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THE GRADED REDEFINED ASSESSMENT OF STRENGTH, SENSIBILITY AND PREHENSION (GRASSP): DEVELOPMENT OF THE SCORING APPROACH, EVALUATION OF PSYCHOMETRIC PROPERTIES AND THE RELATIONSHIP OF UPPER LIMB IMPAIRMENT TO FUNCTION By Sukhvinder Kalsi-Ryan A thesis submitted in conformity with the requirements for the degree of Doctor of Philosophy Graduate Department of Rehabilitation Science University of Toronto ©Copyright by Sukhvinder Kalsi-Ryan (2011)

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Page 1: THE GRADED REDEFINED ASSESSMENT OF STRENGTH, … · Upper limb function is important for individuals with tetraplegia because upper limb function supports global function for these

THE GRADED REDEFINED ASSESSMENT OF STRENGTH, SENSIBILITY AND

PREHENSION (GRASSP): DEVELOPMENT OF THE SCORING APPROACH,

EVALUATION OF PSYCHOMETRIC PROPERTIES AND THE RELATIONSHIP

OF UPPER LIMB IMPAIRMENT TO FUNCTION

By

Sukhvinder Kalsi-Ryan

A thesis submitted in conformity with the requirements

for the degree of Doctor of Philosophy

Graduate Department of Rehabilitation Science

University of Toronto

©Copyright by Sukhvinder Kalsi-Ryan (2011)

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ABSTRACT

THE GRADED REDEFINED ASSESSMENT OF STRENGTH, SENSIBILITY AND

PREHENSION (GRASSP): DEVELOPMENT OF THE SCORING APPROACH,

EVALUATION OF PSYCHOMETRIC PROPERTIES AND THE RELATIONSHIP

OF UPPER LIMB IMPAIRMENT TO FUNCTION

Sukhvinder Kalsi-Ryan

Doctor of Philosophy, 2011

University of Toronto

Graduate Department of Rehabilitation Science

Upper limb function is important for individuals with tetraplegia because upper limb

function supports global function for these individuals. As a result, a great deal of time and

effort has been devoted to the restoration of upper limb function. Appropriate outcome

measures that can be used to characterize the neurological status of the upper limb have been

one of the current barriers in substantiating the efficacy of interventions. Techniques and

protocols to evaluate changes in upper limb neurological status have not been applied to the

SCI population adequately. The objectives of this thesis were to develop a measure; which is

called the Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP).

Development of the scoring approach, testing for reliability and construct validity, and

determining impairment and function relationships specific to the upper limb neurological

were established. The GRASSP is a clinical measure of upper limb impairment which

incorporates the construct of “sensorimotor upper limb function”; comprised of three

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domains which include five subtests. The GRASSP was designed to capture information on

upper limb neurological impairment for individuals with tetraplegia. The GRASSP defines

neurological status with numerical values, which represent the deficits in a predictive pattern,

is reliable and valid as an assessment technique, and the scores can be used to determine

relationships between impairment and functional capability of the upper limb. The GRASSP

is recommended for use in the very early acute phases after injury to approximately one year

post injury. Use of the GRASSP is recommended when a change in neurological status is

being assessed.

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ACKNOWLEDGEMENTS The journey of completing my PhD has not been without tremendous support from my colleagues, mentors, friends and family. I am grateful to the many individuals in the Allied Health and Neurosurgery Departments at the Toronto Western Hospital who have provided me with an extraordinary work environment, which has supported me and my endeavors over the past years. We do not always realize what our true capabilities are, however, often others recognize that,

“Everything you need is already inside” -Bill Bowerman

My committee and supervisor have provided me with great support, guidance and encouragement. It is with their help I have realized my true potential. For this I would like to Thank each member of my committee: Dr. Milos Popovic for providing the knowledge and resources to assist in commercializing this work; Dr. Dorcas Beaton for guiding the process and analysis and helping in developing the GRASSP project from the beginning to the end; and Dr. Michael Fehlings for providing great knowledge of the field and providing opportunities which allowed the GRASSP project to grow. My supervisor Professor Molly Verrier has not only inspired me throughout my PhD studies but throughout my entire professional and academic career. Molly has provided for me the tools to build foundations as a clinician and researcher, has helped me grow through this journey and has taught me, how to learn. Molly was well aware of my potential long before I was. I would like to thank the GRASSP International Research and Design Team who placed their faith in me, to lead the GRASSP project and for their support and provision of resources. Particularly, Dr. Armin Curt who supported my development and growth throughout this project. Also, Depeng Jiang who provided assistance with analysis of the data. I am blessed to have two wonderful extended families. Both my husbands and my own, parents and siblings have supported our family so that I was able to succeed in this endeavor. And finally to my family, I am forever grateful; my husband Timothy, who is my rock and the one who never once stopped supporting my goals and endeavors; and my children Alanzo, Maya and Saphira who have given me the most important things in life. Thank you for helping me attain my goals and providing me with the strength and support to finish what I had started. I would also like to acknowledge the Toronto Rehabilitation Institute Student Scholarship Fund, Ontario Neurotrauma Foundation, Christopher and Dana Reeve Foundation, Rick Hansen Foundation, SCI Solutions Network and the Physiotherapy Foundation of Canada for the academic and research support for the GRASSP project.

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DEDICATION

To my parents, who everyday set an example for me and instilled in me the key to success as being “hard work and only hard work” and that if you believe in something commit yourself to it. “No one ever attains very eminent success by simply doing what is required of him; it is the amount and excellence of what is over and above the required that determines the greatness of ultimate distinction.” -Charles Kendall Adams

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TABLE OF CONTENTS

Abstract ii Acknowledgements iv Dedication v Table of Contents vi List of Tables x List of Figures xii List of Abbreviations xiii Glossary of Terms xiv List of Appendices xviii

CHAPTER I: INTRODUCTION AND LITERATURE REVIEW

1.1 Introduction 1

1.2 Literature Review 2

1.2.1 Epidemiology of Spinal Cord Injury 2

1.2.2 Classification of the SCI population 3

1.2.3 Recovery and Function after Tetraplegia 5

1.2.3.1 Neurological Recovery 6

1.2.3.2 Functional recovery 7

1.2.4 The Components and Function of the Upper Extremity and Relevance

in Tetraplegia 8

1.2.5 Available Outcome Measures for Spinal Cord Injury 14

1.2.6 Development of a Measure for Clinical Research 19

1.2.6.1 Rationale for a New Measure 19

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1.2.6.2 Purpose and the Conceptual Framework of a Measure 20

1.2.6.3 Psychometric Characteristics of Measures 20

1.3 The Graded Redefined Assessment of Strength Sensibility and Prehension

(GRASSP) 22

1.3.1 Conception and Development of the GRASSP 22

1.3.2 Description of the GRASSP 26

CHAPTER II: RESEARCH OBJECTIVES & HYPOTHESES

2.1 Significance and Purpose 27

2.2 Research Objectives and Hypotheses 27

2.2.1 Development of the Scoring System 28

2.2.2 Psychometric Testing 29

2.2.3 Confirmation of Theoretical Framework 30

CHAPTER III: GENERAL METHODS

3.1 Recruitment of Sites and Examiners 31

3.1.1 Training Workshops 31

3.2 Study Protocol 32

3.2.1 Outcome Measures 32

3.2.2 Sample Size 33

3.2.3 Inclusion and Exclusion Criteria 33

3.2.4 Study Participant Recruitment 33

3.2.5 Study Design 34

3.2.6 Data Management 34

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3.3 Sample 35

CHAPTER IV: RESULTS PART 1

4.1 Development of the Scoring Approach for the Graded Redefined Assessment of

Strength Sensibility and Prehension (GRASSP) 39

4.2 Abstract 39

4.3 Introduction 41

4.4 Methods 45

4.5 Results 49

4.6 Discussion 54

CHAPTER V: RESULTS PART 2

5.1 The Graded Redefined Assessment of Strength Sensibility and Prehension

(GRASSP) – Reliability and Validity 59

5.2 Abstract 59

5.3 Introduction 60

5.4 Methods 65

5.5 Results 67

5.6 Discussion 73

CHAPTER VI: RESULTS PART 3

6.1 Sensory and Motor Relationships to Prehension and Upper Limb

Function 78

6.2 Abstract 78

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6.3 Introduction 80

6.4 Methods 83

6.5 Results 89

6.6 Discussion 96

CHAPTER VII: GENERAL DISCUSSION

7.1 Summary of Findings 100

7.1.1 Objective One: Development of the Scoring System 101

7.1.2 Objective Two: Psychometric Testing 102

7.1.3 Objective Three: Confirmation of Theoretical Framework 102

7.2 Impact, Significance and Strengths of the Research 103

7.3 Limitations of the Project 106

7.4 Future Directions 108

7.5 Final Summary 109

REFERENCES 110

APPENDICES 126

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LIST OF TABLES

Table 1: Outcome Measures Used for SCI and Upper Limb Assessment 16

Table 2: Components of the Initial GRASSP and Methods of Administration 25

Table 3: Phases of Development, Objectives and Outcomes for the GRASSP Project 26

Table 4: Description of the Sample and Breakdown of Data received from Participating

Sites (presented by n values) 35

Table 5: AIS Classification of European (n=27) and North American (n=45) Sub Samples

(presented in percent and n values) 36

Table 6: ISCSCI Motor and Sensory Neurological Levels of European (n=27) and North

American (n=45) Sub Samples (presented by percent and n values) 36

Table 7: Demographic, Comparator Measure and GRASSP Results for Total

Sample n=72 38

Table 8: Example of Guttman Scaling Using Scores of Palmar Sensation Items 48

Table 9: Demographics of the Sample Based on ISCSCI sensory and motor levels and AIS

Classification, n=72, (presented as n values and percentages of sample) 50

Table 10: Portion of Sample which presented with and without a Cumulative Predictive

Pattern for each Subtest Total Score in the GRASSP (presented by n value and

Percentage) 51

Table 11: ISCSCI and SCIM benchmarks for GRASSP Discriminative

Score Ranges 53

Table 12: Reliability Values of Subtest Scores Within the GRASSP 69

Table 13: Construct Validity Agreeement/Discordance of Sensory Results

Between GRASSP and ISCSCI (n=72) 71

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Table 14: Level of Agreement Between GRASSP-SWM and ISCSCI-LT

for C6, C7 and C8 71

Table 15: Construct Validity Agreement/Discordance of Strength Results

Between GRASSP and ISCSCI (n=72) 72

Table 16: Concurrent Validity of GRASSP Subtests and Functional Measures 73

Table 17: GRASSP Scoring Details (Subtest and Item Scores and Ranges) 83

Table 18: Demographics of the Sample Based on ISCSCI and AIS Classification,

n=72, (presented as n values and percentages of sample) 90

Table 19: Correlation Matrix of all Variables Included in the Multiple Linear Regression

and Structural Equation Modeling Analysis 91

Table 20: Unadjusted Multiple Linear Regression Values for Sensibility,

Stength and Prehension 92

Table 21: Attributes of the GRASSP Version 1.0 104

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LIST OF FIGURES

Figure 1: Theoretical Framework for the Construct of Sensorimotor Upper Limb

Function used for the Development of the GRASSP 23

Figure 2: Frequency Histograms Describing ISCSCI Sensory and Motor Levels and AIS

Classification For Total Sample (n=72) 37

Figure 3: GRASSP (Components) Version 1.0 42

Figure 4: A Visual Representation of GRASSP Subtest Scores 57

Figure 5: Summary of GRASSP Components 64

Figure 6: Histograms of Sample Distribution 68

Figure 7: Model D, Hypothetical Model of Impairment and Sensorimotor Upper Limb

Function in Tetraplegia to be tested with Structural Equation Modeling 89

Figure 8: Results of Multiple Linear Regression of Impairment Variables and

Upper Limb Function 93

Figure 9: Model D, Structural Equation Model for Impairment and Sensorimotor

Upper Limb Function after Tetraplegia 95

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LIST OF ABBREVIATIONS

AIS: The American Spinal Injury Associations Impairment Scale

CFI: Comparative Fit Index

CUE: Capabilities of Upper Limb Function Questionnaire

FES: Functional Electrical Stimulation

GRASSP: Graded Redefined Assessment of Strength, Sensibility and Prehension

ICC: Intra class correlation coefficient

ISCSCI: International Standards of Neurological Classification of Spinal Cord Injury

ISCSCI-ML: International Standards of Neurological Classification of Spinal Cord Injury

Motor Level

ISCSCI-SL: International Standards of Neurological Classification of Spinal Cord Injury

Sensory Level

RMSEA: Root Mean Standard Error of Approximation

SCI: Spinal cord Injury

SCIM: Spinal cord Independence Measure

SCIM-SS: Spinal cord Independence Measure, Selfcare Subscale

SS: Somatosensory Stimulation

SRMR: Standardized Root Mean Square

TLI: Tucker Lewis Index

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GLOSSARY OF TERMS

AIS: Refers to the classification of spinal cord injury as defined by the American Spinal Injury Association’s Impairment Scale, and is used in conjunction with the ISCSCI motor and sensory levels (A – sensory and motor complete, B – sensory incomplete, C – motor incomplete, D – sensory and motor incomplete). Anatomic Injury: Location of damage to structures in the spinal colum including ligaments, bones, vessels, cartilage and nerves. Capabilities of Upper Extremity Questionnaire (CUE): Self perceived measure of upper limb function specific to tetraplegia (Marion et al., 1998). Compensation: A method to perform an act by using alternative materials and measures in comparison to the normal method to perform that same act. Component: A factor which contributes to a larger concept. Construct: The ideas and concepts which define the basis of a well designed measure. Dermatome: The area of skin on the body which is mainly supplied by a single spinal nerve. Dichotomous Variables: A variable which is derived from only two response levels, “0” or “1”. Dorsal Sensation: The first subtest in GRASSP which assesses three locations on the dorsal surface of the hand, with a score range between 0 to 12. Element: An aspect which is one of many in relationship to a larger concept.

Feedback Control: The situation in the neurological system when output from previous events influence occurrences of the same phenomenon in the present or future.

Feedforward Control: The mechanism related to the neurological system that monitors performance inputs rather than outputs, and provides information to maintain a specified state, thus preventing or minimising problems, and refining movement. Function: An ability to perform goal oriented tasks and self-care tasks independently in any environment for any purpose. Functional Recovery: To regain loss in function in the direction of returning to the original state. Global Function: Ability to perform tasks independently which enable one to provide care for personal well being including tasks related to the whole body.

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Guttman Scaling: The procedure to determine whether a set of items can be rank-ordered in a unidimensional scale (Guttman, 1944; Guttman, 1950). Impairment: A reduction in strength and/or sensation and/or prehension in comparison to the normal neurological state, within the work of this thesis. Independence: The ability to perform functional tasks without the assistance from another individual. Integrated Systems: The incorporation of all the systems which function collectively to perform movement and function. The International Standards for Neurological Classification of Spinal Cord Injury (ISCSCI): A classification measure which defines severity of spinal cord injury according to spinal cord level determined by testing of dermatomes and myotomes. Latent Trait Variable: The unobserved variable, indicated or estimated by other observed variables which is included in path analysis. Level of Impairment: The amount of impairment defined by a measure or value. Level of Injury: The most caudal level, at which sensory and motor spinal cord function are fully intact. Manipulation: Skillful and controlled movements of the five digits and palm of the hand incorporating fine motor control and sensibility. Myotome: A group of muscles innervated by a single spinal nerve. Neural Repair: The restoration or replacement of damaged neural structures. Neurological Integrity: The status of the neurological state specifically in reference to sensation and strength of the upper limb, within the work of this thesis. Neurological Recovery: To regain loss of neurological status (impairment) in the direction of returning to the original state. Palmar Sensation: The second subtest in GRASSP which assesses three locations on the palmar surface of the hand, with a score range between 0 to 12. Path Analysis: One type of structural equation modeling which evaluates the directional dependencies among a set of variables. Polychotomous Variables: A variable which is derived from more than two response levels. Prehension: The act of gripping or grasping something with the hand.

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Prehension Ability: The fourth subtest of the GRASSP which assesses one’s ability to generate three specific prehension patterns, with a score range of 0 to 12. Prehension Performance: The fifth subtest of the GRASSP which assesses one’s ability to perform six tasks and rated according to whether that individual is able to incorporate the expected prehension pattern, with a score range of 0 to 30. Reach: The extension of the arm by way of the shoulder and elbow to approach a target for the hand to perform prehension and manipulation. Recovery: To regain loss. Response Item: The individual component/s that are measured within a test. In the case of GRASSP the response items are the individual muscles, or sensory locations measured. Scaling: The assignment of objects to numbers according to a rule. Semmes Weinstein Monofilaments: Monofilaments of variable stiffness that apply different levels of grams of force used to quantify cutaneous sensation. Sensation: The perception associated with stimulation of a sense organ Sensibility: Functional sensation of the hand, usually associated with palmar sensation. “Sensibility”: Common sense aspects of clinical measure. Sensorimotor: Sensory and motor integration in the context of movement. Spinal Cord Independence Measure (SCIM): Measure of global independence specifically designed for individuals with spinal cord injury (Catz et al., 2004). Spinal Cord Independence Measure Selfcare Subscore (SCIM-SS): Grooming and selfcare subscale within the SCIM which includes the assessment of items related to use of the upper limbs to perform a range of activities of daily living (Catz et al., 2007). Strength: The third subtest of the GRASSP which assesses the muscle force of ten muscles in the arm and hand, with a score range of 0 to 50. Structural Equation Modelling: General, powerful multivariate analysis technique used to determine causal relationships among variables. Tetraplegia: Dysfunction of all four limbs due to the insult or injury to the spinal cord in the cervical region of the spine, including levels from the occiput down to thoracic vertebrae 1. Trait: A distinguishing feature. Traumatic: A physical injury caused by trauma.

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Upper Limb: The complex which includes the shoulder, elbow and hand.

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LIST OF APPENDICES

Appendix 1 126

Appendix 2 160

Appendix 3 162

Appendix 4 165

Appendix 5 180

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CHAPTER I: INTRODUCTION AND LITERATURE REVIEW

1.1 Introduction

Neurological recovery of the upper extremity after tetraplegia is the main factor

which has been influencing the need for a precise, detailed measure of upper limb

impairment specific to tetraplegia. Classification of spinal cord injury (SCI) is established for

individuals by the International Standards for Neurological Classification of Spinal Cord

Injury (ISCSCI) which includes the American Spinal Injury Association’s Impairment Scale

(AIS) (Marino, 2000); this measure incorporates assessment of the trunk and four limbs and

designates severity of injury with respect to the whole body. Thus, researchers have not been

able to determine subtle neurological change in the upper limb using the ISCSCI because it

was not designed to be specific to the upper limb. As a result of the void for an upper limb

impairment measure specific to tetraplegia, the Graded Redefined Assessment of Strength,

Sensibility and Prehension (GRASSP) was developed.

The GRASSP is an assessment strategy with three domains that provides a detailed

profile (integrated sensorimotor function) of the upper limb for individuals with tetraplegia,

both at a single time point and longitudinally. The International GRASSP Research and

Design Team were brought together in May of 2006 by the Christopher and Dana Reeve

Foundation to design and develop the GRASSP (see Appendix 1).

The research presented in this thesis relates to the development of the scoring approach,

psychometric testing, and the relationships between upper limb impairment and function. The

work presented in this thesis falls within the larger GRASSP project. Chapter 1 provides a

literature review of the pertinent issues related to measurement of the upper limb after

tetraplegia and reviews previous development of the GRASSP. Chapter 2 provides the

rationale, objectives and hypotheses of the study. Chapter 3 presents the general methods

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section which details the data collection process and sampling. Chapters 4, 5 and 6 present

the results in the form of three manuscripts. Chapter 7 presents a summary and general

discussion. Initial development of the GRASSP including the: theoretical framework, item

generation and item reduction has been reported in a previous manuscript (Kalsi-Ryan et al.,

2009).

1.2 Literature Review

1.2.1 Epidemiology of Spinal Cord Injury

The incidence of traumatic SCI worldwide is approximately 22 persons/million,

essentially creating 130,000 new spinal cord injured individuals yearly. The prevalence is

estimated at 2.5 million and the average age at time of injury is 33.4 years. Fifty percent of

injuries are caused by motor vehicle accidents and yearly health care costs from four nations

(Canada, USA, Australia, and England) total approximately $10 billion dollars per annum

(Campaign for Cures, 2010). A recent systematic review reported that there is a general trend

world wide towards increased incidence in the elderly due to falls and non-traumatic SCI

(van den Berg, et al., 2010). The International Campaign for Cures of spinal cord injury

Paralysis (ICCP) provides the best possible global data; however, the majority of the data is

garnered from developed countries (Campaign for Cures, 2010). Not only does this prevent

the true international incidence and prevalence of SCI from being captured, the data also fails

to impress the significance and enormous strain that SCI places on society and the economy.

In 2001/2002 the incidence of SCI in Canada was reported to be approximately

1050/year or 35 persons/million (Rick Hansen Registry, 2005). Although there is no exact

figure, it is estimated that 41,000 people live with a SCI in Canada.

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SCI is most prevalent in age groups below 50 years, meaning that individuals will

live close to 40 years with enormous care needs. Not only do these persons require a

significant amount of care, they require it for prolonged periods of time which in turn

generates larger lifetime care costs than other diseases such as stroke. Although Canadian

statistics report that approximately 50% of SCI are cervical injuries, reports from more recent

international reviews including literature from Canada (Wyndaele and Wyndaele, 2006)

report an increase in the ratio of individuals with tetraplegia and incomplete injuries to be

above 50%.

In Canada it is estimated that the lifetime care costs for an individual with paraplegia

is $1.25 million; and for an individual with tetraplegia is around $25 million. Although the

incidence and prevalence of SCI is low in comparison to other diseases, the care costs are

enormous; approximately $1.5 billion per year is spent on managing SCI by the Canadian

Health Care System (Rick Hansen Registry, 2005). With such a significant impact on those

with injury, and the individuals who provide care for people with tetraplegia, across a

lifetime; restoring function is imperative.

1.2.2 Classification of the SCI population

Traumatic SCI encompasses injuries to the spine and spinal cord, which can occur

anywhere along the spinal column (cervical, thoracic, and lumbar) as a result of trauma.

Injuries to the thoracic and lumbar spine result in paraplegia while injuries to the cervical

spine result in tetraplegia. The significant difference between these two general classes of

injury is that an individual with paraplegia would retain normal upper limb function;

however, the level of injury determines whether or not the individual retains postural control.

On the other hand, individuals with tetraplegia not only lose the function of the lower body,

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but also function of the upper limbs which are vital in maintaining independence after a SCI.

Depending on the level of injury the degree of upper limb impairment varies; an injury to the

higher levels of the cervical spine will cause greater impairment in the upper limbs. The

degree of impairment is reduced as the level of injury moves from the occiput towards T1.

When a spinal cord injury occurs the structures including: bone, ligaments, cartilage,

vessels and nerves are damaged by the trauma. The location of the actual damage to the

structures is called the anatomic injury or spinal injury which should be defined separately

from the neurological injury (Middendorp et al., 2010). For example an individual may

sustain a C5 fracture and dislocation, which would be a C5 anatomic injury. The damage that

occurs to the spinal cord may or may not be at the same level. Although, spinal cord damage

can be measured by MRI imaging, maximal spinal cord compression, lesion length and

spinal cord hemorrhage which do correlate with severity of SCI and prognosis according to

the ISCSCI (Miyanji et al., 2007) are not widely used. The neurological level of injury that

occurs as a result of trauma based on spinal cord integrity defined by the impairment at the

periphery is the most universally used method to define SCI. Thus, the neurological level of

injury is defined by the most caudal level of normal neurological intactness.

SCI is defined by the neurological level of injury which is usually defined by the

most caudal level at which sensory and motor function are fully intact according to the

ISCSCI. Classification of the SCI is defined by the AIS which is part of the ISCSCI and

defines whether the injury is complete or incomplete. A complete SCI occurs when there is

no motor or sensory function preserved in the sacral segments S4-S5 (A). There are three

classes of incomplete SCI. An incomplete injury occurs when there is sensory but not motor

function preserved below the neurological level and includes the sacral segments S4-S5 (B),

or motor function is preserved below the neurological level, and more than half of the key

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muscles below the neurological level have a muscle grade less than three (C), or motor

function is preserved below the neurological level, and at least half of the key muscles below

the neurological level have a muscle grade of three or more (D) (Marino, 2000). Based on an

international review of SCI epidemiology, the prevalence of completeness is approximately

40% complete and 60% incomplete (Wyndaele and Wyndaele, 2006).

In addition to the neurological level of injury and the classification of completeness,

there is a zone of partial preservation where there is partial integrity of the spinal cord that

does not contribute to the neurological level assigned by ISCSCI.

Traditionally, individuals with complete SCI do not gain any motor or sensory

function below the neurological level of injury, whereas individuals with incomplete injuries

can due in part to the zone of partial preservation. This essentially results in spontaneous

recovery of sensory and motor deficits. However, the degree of recovery and the way in

which the recovery can influence function varies significantly from individual to individual,

and is not always predictable. Therefore, two elements contribute to a heterogeneous

tetraplegic population: the first is the difference in upper limb intactness secondary to the

neurological level of injury and classification and the second is the varying degree of

recovery. The variance in the tetraplegic group creates many complexities in developing an

upper limb measure of impairment.

1.2.3 Recovery and Function after Tetraplegia

The term recovery refers to the changing state (improvement) of neurophysiology

and/or functional capacity. After tetraplegia, even if an injury is complete it is common to

anticipate some type of recovery. In the case of complete injuries, where no neurological

change is expected, the anticipated recovery is functional. In the case of incomplete injuries

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the anticipated recovery is both neurological and functional. Neurological recovery refers to

changes in impairment, while functional recovery refers to a change in ability; in both cases,

depending on the severity of injury either type of recovery, or both, can be expected.

1.2.3.1 Neurological Recovery

Outside of neural repair there is evidence to support neurological recovery. Motor

recovery of key muscles does occur in the upper limb after complete and incomplete cervical

SCI injuries. Varying degrees of local recovery can be expected in tetraplegic individuals.

Motor recovery can be predicted by the acute motor intactness early after injury (Ditunno et

al., 2000; Ditunno et al., 1987; Fisher et al., 2005). It has also been noted that gains in

strength of elbow and shoulder muscles can continue to occur up to 15 months post discharge

from rehabilitation (Drolet et al., 1999). Individuals with preservation of sensation to pin

prick in a motor segment with grade zero power, showed an 85% chance of motor recovery

to at least grade three (Poynton et al., 1997). Some of the recovery in strength may be

attributed to plasticity within the spinal cord. Corbetta et al. reported that even with greater

than 75% loss in spinal cord area, functional neural connections that traverse the site of cord

injury still exist (Corbetta et al., 2002). Sensory evoked potentials performed in the acute

phase of cervical SCI are indicative of level of SCI and have been found to be predictive for

recovery of hand function (Curt and Dietz, 1996). Although, the regeneration of nerve fibers

is limited in the adult central nervous system, changes in function occurring for several years

after injury can be dependent on the reorganization of circuits which are spared by the lesion

(Green et al., 1999) and cortical reorganization (Jurkiewicz et al., 2007; Raineteau and

Schwab, 2001; Bruehlmeier et al., 1998; Cohen et al., 1991; Levy et al., 1990). With the

cortical reorganization that does occur after SCI, it is theorized that the sensorimotor cortex

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plays a critical role in the recovery of function. Therefore, the spared sensation at time of

injury which is often followed by motor recovery (Poynton et al., 1997) may partially be

related to the changes that occur in the sensorimotor cortex and reorganization of tracts.

Measurement of global neurological recovery has been demonstrated with the ISCSCI

(Marino et al., 2003), which is a classification measure used to define severity of SCI and

was not designed to be specific to the upper limb. As it does not include sensory testing for

the palmar surface of the hand and it measures the strength of a limited number of muscles of

the upper limb and hand. Therefore, a more comprehensive sensorimotor profile of the upper

limb was necessary to report the subtle changes that occur post tetraplegia and to determine

how these subtle changes could affect one’s level of functional independence.

1.2.3.2 Functional recovery

Recovery of function and independence has also been documented for individuals

with tetraplegia. Individuals post-tetraplegia improve their ability to function after a period of

rehabilitative intervention (Ota et al., 1996), and often continue to improve once discharged

into the community. When improvement of function is documented, both complete and

incomplete groups of SCI show improvement (Welch et al., 1986). This would indicate that

an individual who would make no progress in neurological status can make progress in

functional status, due to skill acquisition or adaptation (Müslümanoğlu et al., 1997). Function

in the cervical SCI population is often assessed by measures of

function/independence/burden of care, which are not all SCI specific. The Functional

Independence Measure (FIM) (Keith et al., 1987); is a generic measure used for many

populations with diverse disabilities and measures burden of care. There are also two

measures of function specific to SCI; the Quadriplegia Index of Function (QIF) (Marino et

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al., 1999), and the Spinal Cord Independence Measure (SCIM) (Catz et al., 2004). These

measures rate an individual’s level of function with and without assistance and assistive

devices. Although the QIF and FIM results are related to functional recovery over time, both

measures require more sensitivity to be discriminative (Marino et al., 1993) as compensation

may be the factor influencing the changes. Strength in specific muscle groups can predict

greater functional outcomes; elbow flexion, shoulder flexion and wrist extension all correlate

higher with tasks in both the FIM and the QIF (Beninato et al., 2004; Marciello et al., 1995).

Specifically shoulder strength and elbow extension strength show stronger associations to

functional independence than other muscle groups in the upper limb (Fujiwara et al., 1999;

Welch et al., 1986).

Neurological and functional recovery are well evidenced in the SCI literature,

however, it is predominantly based on global function and impairment as defined by the

ISCSCI, FIM and QIF. There remains little evidence that defines the recovery of upper limb

impairment in tetraplegia.

1.2.4 The Components and Function of the Upper Extremity and Relevance in

Tetraplegia

The key actions of upper extremity function are considered to be reach, grasp and

manipulation skills (Shumway-Cook and Woollacott, 2007). The systems theory of motor

control predicts that there are specific neural and musculoskeletal subsystems that contribute

to the control of these three components.

Voluntary performance of an upper limb function is controlled by complex neural

circuits in the brain inter connecting the sensory and motor systems. The sensory, motor and

motivational systems each have anatomically and functionally distinct subsystems (whereby

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hand manipulation and reach are not controlled by precisely the same subsystem components

in an individual) that perform specific tasks during the performance of voluntary movement

(Shumway-Cook and Woollacott, 2007), such as reaching and grasping. The decision to

initiate a voluntary movement is regulated by the motivational system which acts directly on

the motor system (Kandel et al., 2000). Concurrently the sensory system begins processing

information regarding the targeted task and begins sending information to association areas

of the cortex where movement is planned. The processed sensory information is transmitted

to the motor system. The motor system then executes and regulates the movement based on

continuous sensory information. Direct and indirect pathways relay motor control

information. The direct system regulates the activity of the motor neurons that innervate

muscles of the hand and arm involved in the fine control of movement. The indirect system

plays an important role in the overall regulation of body posture and stability. The indirect

motor system includes synaptic relays, whereas the direct motor system does not.

The general areas of the cerebral cortex which are critical in the control of reach,

grasp and manipulation are the primary motor cortex, the somatosensory cortex, premotor

cortex and areas of the posterior parietal lobe (Filimon, 2010). The cerebellum is also

important for feedforward and feedback control. Afferent fibers carry somatosensory

information from the periphery in the dorsal columns on the same side until the medulla

where the cells synapse in the dorsal column nuclei and cross to the other side and ascend to

the thalamus. In the thalamus sensory input is relayed to the primary sensory areas of the

cerebral cortex as well as information regarding motor behaviour to the motor areas of the

cortex. Axons from the primary motor cortex project directly to motor neurons in the spinal

cord via the corticospinal tract which is a descending tract in the ventral column of the spinal

cord. The descending corticospinal tract crosses to the opposite side of the spinal cord in the

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medulla just caudal to the dorsal nuclei. Approximately 10% of the fibres remain ipsilateral

until termination in the spinal cord. Corticospinal axons terminate on groups of motor

neurons in the spinal cord that innervate specific limb muscles. The corticospinal tract

primarily controls distal muscles that are important for precise movements, such as those of

the hand. Other motor pathways, which originate in the brainstem nuclei mediate postural

adjustments during movement (for a detailed discussion of this subject please see Kandel et

al., 2000, Chapter 19 for more detail).

Upper limb function is generated by the anatomical structures of the arm. The

anatomy of the upper limb includes five main joints: the sternoclavicular joint, the shoulder

joint, elbow joint, the wrist joint and hand joints. The associated musculature that surrounds

these joints are the muscles: of the shoulder girdle, the upper and lower arm; and the wrist

and hand (Moore, 1985; Netter, 1989). The muscles and overlying skin of the upper limb are

innervated by the anterior and dorsal horns which emerge from the cervical spinal cord

between the fourth cervical vertebrae and the first thoracic vertebrae known as the C5 to T1

nerve roots. Nerve roots which emerge on the right side innervate the right side only and

similarly for the left side. The peripheral representations of the nerve roots for muscles are

known as the myotomes and of the skin are known as the dermatomes. Each myotome and

dermatome has specific representations at the periphery. The representation of the myotomes

and dermatomes, although defined can vary from individual to individual. Specifically,

proximal muscles of the upper limb are innervated by C5 and as the muscles become more

distal, the innervation moves caudally to T1 (see Moore, 1985 for more detail). Sensation of

the upper limb is represented by the nerve roots between C5 and T1. The hand is specifically

represented at the levels of C6, C7 and C8. Due to the specific representations of the spinal

cord at the periphery via myotomes and dermatomes, impairment measured at the periphery

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is reflective of the neurological integrity at the cord level. Thus the anatomy is often used as

the basis for neurological assessment at the periphery.

Upper limb function is comprised of three components which contribute to

performance of tasks; reach, prehension and manipulation (Shumway-Cook and Woollacott,

2007). Stability is provided by the proximal structures of the shoulder girdle which enable

the arm to move freely and reach to be a form of transport, which is produced by the shoulder

and elbow joint in association with the musculature and innervation that surround these two

joints. These two joints transport the hand to the location of the task. Prehension is produced

by the wrist and hand structures with the associated joint and skin sensory receptors and

musculature, incorporating the actions of grasp and release. Manipulation is produced by the

sensibility of the palmar surface and motor control of the small muscles of the hand and the

associated joints to produce an extraordinary organ which can perform fine movements and

functions (Brand and Hollister, 1991; Shumway-Cook and Woollacott, 2007). Therefore,

assessment of upper limb impairment requires a measure which acknowledges the

components (sensory and motor) as well as upper limb function (integration).

Not only do the upper limbs perform the functions for which normal individuals use

their hands, but they replace the functions for other parts of the body that may no longer have

even partial function (i.e. leg function for walking, replaced by wheelchair propulsion). The

upper limbs for an individual with tetraplegia represent all self-care activities including

locomotion, bowel and bladder function, recreational activities and vocational activities.

Improvement in upper limb function after cervical SCI is one of the most significant factors

in improving quality of life according to individuals with tetraplegia (Anderson, 2004;

Snoek, 2004). Therefore, the more normal and precise the recovered upper limb function is

after tetraplegia the more functional the individual will be. The field of upper limb

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restoration research is quite new; interventions have only been studied with some emphasis

since the 1960’s due to the fact that survival of high tetraplegics was poor prior to this era

(Lamb and Chan, 1983).

As a result of the emphasis placed on upper extremity function by the SCI population

and society and the increasing potential for optimizing recovery (increased proportion of

individuals with incomplete SCI), intense interest has been generated in the development of

therapies for preserving and restoring upper limb function. Furthermore, the degree of injury

along with the spinal cord structures affected also contributes to the varying degrees of

presentation of impairment and potential for recovery. Therefore, interventions for the

improvement of upper limb function not only need to incorporate compensatory therapeutic

strategies but also restorative interventions that reduce the impairment. The potential to

restore lost upper limb function in SCI is influenced by three factors: 1) a higher rate of

incomplete injuries (Sekhon and Fehlings, 2001; Marino et al. 1999), which will tend to

increase the rates and magnitude of recovery; 2) development of therapeutic interventions

that are applied at the periphery to affect the sensorimotor system (Popovic et al., 2006;

Beekhuizen and Field-Fote, 2005); and 3) development of interventions that are applied to

the central nervous system such as pharmacological agents and biologics with the potential

for neural repair, neuro-protection and regeneration (Schwab et al., 2006; Wells et al., 2003;

Baptiste and Fehlings, 2007).

The potential to target rehabilitative approaches towards specific muscle groups that

have a known potential to recover, and have a greater impact on functional independence is

knowledge available from the current literature that reports and defines recovery (Ditunno et

al., 2000; Drolet et al., 1999; Fujiwara et al., 1999; Welch et al., 1986). Although, the

literature is not all upper limb specific it does provide an understanding of the changing

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neurological integrity (motor) post SCI, which assists in framing clinical decision making for

rehabilitative approaches for the different levels of tetraplegia.

There is scientific evidence to support the efficacy of stimulation therapies (including

functional electrical stimulation (FES), and somotosensory stimulation to the median nerve

(SS)). Stimulation therapies can be used as assistive technologies or can be applied as

therapeutic interventions to influence the sensory and motor integrity of the system. Assistive

technologies are beneficial for individuals with C5, C6 or C7 complete tetraplegia once

neurologically stable. These technologies are not therapeutic interventions; rather they are

assistive devices that improve hand function when in place and active (Alon et al., 2003;

Taylor et al., 2002; Peckam et al., 2001; Popovic et al., 1999). Both SS and FES can be

applied as interventions which can improve the voluntary control and strength of the hand

musculature. There is significant evidence to support SS as an adjuvant to rehabilitation

therapies, particularly massed practice. SS in association with a comprehensive rehabilitation

program that is functionally oriented results in improved sensation, motor function,

functional ability and cortical changes related to the trained function (Beekhuizen and Field-

Fote, 2008; Hoffman and Field-Fote, 2007; Beekhuizen and Field-Fote, 2005). FES as an

intervention during the sub-acute phase of recovery has proven to be more effective than

conventional rehabilitation alone when administered as a therapy in conjunction with

functional tasks (Popovic et al., 2006; Miller et al., 2008).

Stimulation therapies are beneficial not only as assistive technologies for the

neurologically stable individual, but also as therapeutic interventions for individuals with

complete or incomplete tetraplegia during the rehabilitation phase of recovery (4wks to 18

months post injury) (Kalsi-Ryan and Verrier, 2010).

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There is less evidence to support the practice of tendon transfer surgery as an

intervention which can be provided once an individual is neurologically stable. Laffont et al

makes a strong argument that with more active joints the greater one’s ability becomes to

grasp, release and manipulate an object (Laffont et al., 2007). Although, some researchers

feel there is adequate research to support tendon transfer surgery, the evidence for tendon

transfer lacks rigor (Vastamaki, 2006; Rothwell et al., 2003; Meiners et al., 2002; Lo et al.,

1998). One of the barriers for successful research related to tendon transfers is the lack of

appropriate and well developed outcome measures.

As a result of the potential spontaneous recovery and the state of upper limb

restoration research in SCI, the need for a specific upper limb impairment measure in

tetraplegia is paramount. According to Wilson et al. the effectiveness of clinical interventions

can only be optimized if the causal relationships between the clinical variables and outcomes

are made, and measures are the link between these two concepts (Wilson et al., 1995). An

upper limb impairment measure for tetraplegia will enable researchers and clinicians to

achieve a degree of precision in the assessment for this specific area. It will also enable an

understanding, an ability to evaluate, and differentiate characteristics of upper limb

impairment in a quantitative manner.

1.2.5 Available Outcome Measures for Spinal Cord Injury

In light of the neurological recovery that does occur post tetraplegia, the necessity to

assess impairment in the form of neurological integrity is crucial. Measuring the upper limb

with a specific and sensitive measure will allow researchers to evaluate the subtle change

occurring in the upper limb secondary to natural recovery and interventions. Although a

number of SCI specific and upper limb (some tetraplegia) specific measures exist,

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impairment of the upper limb (the construct of interest) is not measured with enough

precision by existing tests. Curtin et al. reported that there was inconsistency in evaluation

and documentation within the rehabilitation therapy community due to inappropriate use of

outcomes measures. The best suited measures required to answer research questions were not

used. Furthermore, the sensitivities of the available measures has not been sufficient to

determine significant but small changes (Curtin et al., 2005). Dunn et al. stated it was crucial

that measures have specificity in order to detect small but clinically significant improvements

in hand function (Dunn et al., 2008).

Many of the measures used to date have not been specifically designed for use in the

SCI population, (Dunn et al., 2008; van Tuijl et al., 2002) and, of the measures that are

specific to SCI, many of the psychometric properties are not well established. Identifying the

measures that are reliable, valid and specific to the tetraplegic upper limb is the key element

to performing successful research in the field. Use of functional tests such as the FIM, SCIM

and QIF alone are not sufficient to determine the efficacy of neurophysiological based

interventions; in that they do not identify the changes in neurological integrity. Although

common measures across interventions and timeframes should be employed, specificity of

the intervention and the phase of recovery also determine the choice of outcome measures.

Table 1 describes the available and commonly used measures in SCI and, their applications,

constructs and psychometric properties if available.

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Table 1: Outcome Measures Used for SCI and Upper Limb Assessment Construct Validity Measure and Description Construct and

Population Mode InR ItR

TrT KG ConcV Res Qualities

Impairment International Standards of Neurological Classification of SCI (ISCSCI) Classification measure, used to determine severity of injury. (Marino et al., 2003; Priebe and Waring, 1991)

Whole Body SCI

M 35%-93%

▲ ■ ♦

Grip and Pinch Dynamometry Measure of grip force (Mathiowetz et al., 1984)

Hand Strength Peripheral Hand Injury

M *0.98 *0.99 ● ♦

International Classification for Surgery of the Hand Upper limb motor strength test and two point discrimination of digits (McDowell et al., 1986)

Upper Limb Motor Tetraplegia

M ■ ● ♦

Function The Van Lieshout Test Upper limb capacity seated in a wheelchair (Post et al., 2006; Spooren et al., 2006)

Upper Limb Function Tetraplegia

M *0.98 *0.87 with Grasp and Release

*R ▲ ■ ● ◘

Grasp and Release Test Functional test specific to ability after neuroprosthetic implantation (Mulcahey et al., 2004)

Hand Function Tetraplegia

M *0.87 ▲ ■ ● ◘

Capabilities of Upper Extremity Questionnaire Self perception of functional ability with upper limbs (CUE) (Marino et al., 1998)

Upper Limb Function Tetraplegia

SR *0.96 *0.94 *0.74 with FIM

▲ ■ ● ◘

The Jebsen Hand Function Test Generic hand function test, outcome of time (Jebsen et al., 1969; Sears and Chung, 2010; Beebe and Lang, 2009)

Hand Function Hand Injury

M ● ◘

The Sollerman Hand Function Test Hand Function Test (Sollerman and Ejeskar, 1995)

Hand Function Musculoskeletal

M *0.98 R ▲ ● ◘

Action Research Arm Test (ARAT) Upper limb reach and grasp test. (Lin et al., 2009)

Upper Limb Function Stroke

M *0.92 *0.97 *0.81 with WMFT

● ◘

Wolf Motor Function Test (WMFT) Hand Function Test (Lin et al., 2009)

Hand Function Stroke

M *0.92 *0.97 *0.81 with ARAT

● ◘

Fugl-Meyer Hand Subtest Hand Function Test (Fugl-Meyer et al., 1975; Lin et al., 2009)

Hand Function Stroke

M *0.92 *0.97

*0.81 with ARAT

● ◘

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Global Function/Independence Functional Independence Measure A generic outcome which measures burden of care. (Keith et al., 1987; Kidd et al., 1995)

Independence All disabilities

O 0.70

The Spinal Cord Independence Measure II (SCIM) Measure of global independence (Catz et al., 2004; Itzkovich et al., 2007)

Independence SCI

O *0.94 *0.79 with FIM

▲ ■ ◘

Quadriplegia Index of Function A measure of global function (Marino et al., 1999)

Independence Tetraplegia

O ■ ◘

Lamb and Chan Questionnaire ADL inventory specific to tendon transfer (Lamb & Chan,1983)

Independence Tetraplegia

SR ■ ● ◘

Legend for Table 1: InR – Inter rater reliability, ItR – Intra rater reliability, TrT – Test retest reliability, KG – Known Groups, ConcV - Concurrent Validity, Res – Responsiveness. Mode is the manner by which the measure is administered: M-clinician administers measure and rates individual, O-clinician observes activity of an individual and rates the individual, SR-self reported measure. Psychometric Properties: * - inter rater reliability above 0.8 intra class correlation coefficient, intra rater or test retest reliability above 0.8 intra class correlation coefficient, concurrent validity above 0.7 correlation with a comparator measure, construct validity established, R-responsiveness established at acceptable level Qualities = Qualities of the Measure: ▲- Psychometric properties evaluated with the SCI population, ■ – Construct of measure specific to SCI, ● – Construct of measure specific to the upper limb, ♦ - Construct of measure specific to impairment, ◘ - Construct of measure specific to function

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While it appears that there are a number of available measures, impairment of the

upper limb is not the defined construct for any of the available assessments. In summary the

measures used often with the SCI population are either too global in nature (incorporate the

whole body), designed for different populations, assess a construct other than impairment of

the upper limb, do not include sensory testing specific to the hand, or do not possess the

psychometric properties required (see Table 1). Measuring function and independence are

very important, however, a sound understanding of the core and integrative elements of

neurological integrity which underlie any level of function are also important to understand

because neurological integrity is the factor being targeted with treatment and how it changes

is of interest. The body of literature established by researchers and clinicians in the field of

“Hand Rehabilitation” definitively places a significant emphasis on impairment as well as

functional assessment. The reason being that the core impairments, and how they relate to

the performance of functional tasks is understood (Lundborg and Rosen, 2007; Mackin et al.,

2003) and known to be a key concept in therapeutic interventions. Sensation plays a

significant role in recovery of function. As such training protocols specifically addressing the

sensorimotor relearning process substantially increase the possibilities for improved

functional outcome after nerve repair. Based on the anatomy of the upper limb and the

integrative nature of refined movement; assessment of core elements (sensation and strength)

and integrative elements (performance of functional tasks) of impairment are essential in

making connections between the state of impairment or residual neurological integrity and

function.

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1.2.6 Development of a Measure for Clinical Research

In order to create a measure that will hold strong psychometric properties once

completed the initial development must be sound. The various steps involved in

measurement development should be included in the process to ensure the measure fulfils its

intended purpose.

1.2.6.1 Rationale for a New Measure

Prior to initiating the process of developing a measure, it is necessary to determine

the rationale for a new measure. “The clearest rationale for a new measure is an absence of a

scale directed toward the phenomenon of interest” (Portney and Watkins, 2000). The

phenomenon of interest in this work was, “the assessment of upper limb impairment as a

result of tetraplegia”. The ISCSCI is one measure of impairment for SCI; however, it is a

classification measure for the whole range of SCI, making it non-specific to the upper limb.

The International Classification for Surgery of the Hand (McDowell et al., 1986) is a detailed

motor and sensory assessment of the hand and forearm which has been designed to screen

and classify individuals specifically for tendon transfer surgery; its use for any other purpose

within tetraplegia has not been reported. Grip and pinch dynamometry are not sufficient to

describe all of the impairment that occurs in the whole upper limb. There are a number of

scales specific to the upper limb (not all specific to SCI) which are commonly used to assess

individuals with tetraplegia (Post et al., 2006; Mulcahey et al., 2004; Jebsen et al., 1969;

Sollerman and Ejeskar, 1995; Lin et al., 2009). However, the construct for these functional

tests is hand function or upper limb function, precluding their use for the assessment of

neurological integrity of the upper limb. Therefore, the rationale for developing the GRASSP

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was based on the absence of an impairment measure specific to the upper limb after

tetraplegia.

1.2.6.2 Purpose and the Conceptual Framework of a Measure

The initial work required to design a measure includes establishing a purpose and a

conceptual framework which is used as the basis for measure development (McHorney,

1999). The purpose of the measure defines the phenomenon that is being assessed. In the

case of the GRASSP, the aim was to assess impairment of the upper limb after tetraplegia.

The conceptual framework (Figure 1) that was developed, defined the construct,

“sensorimotor upper limb function” and the domains that were contained within (McDowell

and Jenkinson, 1996). The theoretical framework provided the roadmap for compiling the

GRASSP, which guided the processes of item generation and reduction (McHorney, 1999;

Streiner and Norman, 1995). Section 1.3 defines the theoretical framework designed for the

development of the GRASSP. Once the actual measure was constructed, the GRASSP was

then tested for sensibility, reliability, validity and ultimately is being tested for

responsiveness.

1.2.6.3 Psychometric Characteristics of Measures

“Sensibility” is the aggregate of properties that make up the common sense aspect of

an instrument including: face and content validity (Rowe and Oxman, 1993). Feinstein

defined that the dimensions of sensibility should include: comprehensibility, replicability,

suitability of scale, ease of usage, face validity, content validity and scale purpose (Feinstein,

1990). “Sensibility” is established by having experienced clinicians administer the measure

and then complete a sensibility questionnaire (see Appendix 2). The results of the

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questionnaire provide the required information for modifications to the test. A sensibility

assessment of the GRASSP was conducted during the training workshop in Toronto (January

2007) and the questionnaire results were incorporated into modifications made to the initial

GRASSP which rendered GRASSP Version 1.0. A measure that has sensibility is practical,

assesses the intended population, is easy to administer and demonstrates a comprehensible

results.

Reliability of a test is when the same measurement is obtained when repeated by the

same rater (intra rater) or different rater (inter rater). Test retest reliability replaces intra rater

reliability when the repeated tests are conducted more than three days apart. (Norman and

Streiner, 1995; Portney and Watkins, 2000). Reliability is considered to be a basic and

essential quality of a scientific measure. Scientific investigation can only be performed with a

reliable measure, as a change in measurement can more confidently be attributed to clinical

change; and the number of individuals required in a clinical trial can be reduced. Reliability

of a measure is established when a measure is administered repeatedly to the same stable

individual by the same and/or different examiners. The agreement among results renders the

reliability of a measure. Most commonly agreement statistics or intra class correlation

coefficients (ICC) are used for analysis. Reliability is a necessary step in establishing the

usefulness of measurement; however, it alone is not sufficient.

Validity is when a measure assesses what it is “intended to measure”. Face validity

exists if the measure appears to assess what it is intended to measure, and content validity

exists if the components represent the construct that the measure is intended for. Face and

content validity are established by a review of the measure, usually by an expert or a panel of

experts; this is often incorporated into the “sensibility” questionnaire. Construct validity is

usually established by comparing the new measure to an existing measure which assesses the

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construct of interest. However, if a comparable measure does not exist, other available

measures in the field of interest can be used (Streiner and Norman, 1995). Unlike the analysis

of reliability a wide variety of approaches can be used to establish construct validity.

1.3 The Graded Redefined Assessment of Strength Sensibility and Prehension

(GRASSP)

The Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP)

is a multi-domain clinical impairment measure of the upper limb for individuals with

tetraplegia (Appendix 1).

1.3.1 Conception and Development of the GRASSP

Figure 1 defines the theoretical framework conceived to assemble the GRASSP.

Integration of systems includes: cognition, sensory and motor substrates which are controlled

by feedforward and feedback processing. The integration is the “medium” with which

functions of the upper limb are performed (Kandel et al., 2000). Sensorimotor control and

sensorimotor learning principles are part of the framework as they are the “process” by which

the body learns and maintains refined movement (Shumway-Cook and Woollacott, 2007).

When these two concepts of the framework are considered they produce the construct of

“senorimotor upper limb function”. The construct of “sensorimotor upper limb function”

being an integrated construct is comprised of three domains, in this case sensation, strength

and prehension. Sensation and strength are the two core elements of impairment and

prehension is the integrated element of impairment. In order to specify the framework for

tetraplegia, characteristics related to the spinal cord segments and recovery after injury were

incorporated. In order to connect impairment to function; characteristics of the task oriented

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approach were incorporated into the framework as well. Consideration of integration and

processing, principles, task orientation and SCI pathology were incorporated into the

theoretical framework to ensure the elements contributing to impairment would be

components of the measure developed.

Subtests of the GRASSP were selected based on how well they assessed the domains

within the construct. Items within the subtests were selected to ensure that the three

components (reach, prehension and manipulation) of upper limb movement were captured

(Shumway-Cook and Woollacott, 2007; Kapandji, 1970; Brand and Hollister, 1991). The

domains (sensation, strength and prehension) represent core and integrated elements of

impairment. The purpose of incorporating an integrated domain was to provide the

opportunity to assess how sensation and strength impairments contributed to an integrated

(prehension) function which may be increasingly important in understanding the recovery

process.

Figure 1: Theoretical Framework for the Construct of Sensorimotor Upper Limb Function used for the Development of the GRASSP

Figure 1 illustrates the concepts, principles and structures associated with upper limb function. All elements contribute to the construct “sensorimotor upper limb function” and the domains within, sensation, strength and prehension.

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Items for the GRASSP were generated from existing tests and measures which were

reviewed to determine suitability. The theoretical framework for the GRASSP (Figure 1)

provided a conceptual roadmap to guide initial item generation. In addition to the theoretical

framework suitability for test selection was based on three rationales: a inter and intra rater

reliability of greater than 0.8, evidence of development of the test and availability of

normative data and the tests ability to measure the underlying construct of the domain. Parts

from the Link Hand Function Test (Link, 2004), The Tetraplegia Hand Measure (Kalsi-Ryan,

2006), generic assessment methods for peripheral hand injury (Mackin et al., 2003) and the

Sollerman Hand Function Test (Sollerman and Ejeskar, 1995) were selected, modified and

incorporated to create the GRASSP.

Components adapted from the Link Hand Function Test included five prehension

tasks. In a similar fashion, the sensory module, part of the motor testing, and the scoring

scale from the prehension tasks were adapted from the Tetraplegia Hand Measure. All

components included in the GRASSP are presented in Table 2. The sensibility domain

included Semmes Weinstein monofilaments (SWM) for light touch and static two-point

discrimination (S2PD) for functional sensation. The strength/tone domain was assessed using

manual muscle testing (MMT) for strength (Daniels and Worthingham, 1995; Kendall et al.

1993) and the Modified Ashworth Scale for tone (Bohannon and Smith, 1993). Both

descriptive and performance-based prehension tests were incorporated to address the

prehension domain. The prehension ability test evaluates whether the thumb and digits can

assume three specific grasps or can perform any active movement at all. The prehension

performance test is a modified version of the Sollerman Hand Function Test (Sollerman and

Ejeskar, 1995). The Sollerman was modified by Link and Kalsi-Ryan et al. during the

development of the Link Hand Function Test and the Tetraplegia Hand Measure. The

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prehension domain in the GRASSP retains the Sollerman concept of evaluating specific

activity of daily living tasks performed with specific grasps for evaluation.

Table 2: Components of the Initial GRASSP and Methods of Administration Components of the GRASSP Method for administration Test

Details

Rationale

Position time required

How to test

Sensibility domain: test sites selected by dermatome Light Touch/ SWM (Mackin et al., 2003)

6 palmar/dorsal test sites

Inter/intra-reliability = 0.965

Supine/ sitting, 10 min

Apply monofilaments to all test locations Summate the score for each hand separately

Static 2 Point Disc (Mackin et al., 2003)

3 palmar test sites

Inter/intra-reliability = 0.989

Supine/ sitting, 5 min

Apply stimulus to all test locations Summate score for each hand

Strength and tone domain: muscle selection based on myotomes Strength (Cuthbert and Goodheart, 2007)

MMT-4 arm & 7 hand muscles

Inter reliability = 0.880

Supine/ sitting, 10 min

Assess each muscle and grade Summate all scores for each hand

Tone (Bohannon and Smith, 1993)

Modified Ashworth for hand & arm

Inter-reliability = 0.750

Supine/ sitting, 5 min

Assess elbow and hand for flexor/ extensor tone

Prehension domain: segmental influence movement pattern Prehension Ability

3 grasps rated on scale of 0–4

Supine/ sitting, 5 min

Have subject perform grasps and rate

Prehension Performance (Sollerman and Ejeskar, 1995)

5 grasps/6 tasks rated on scale of 0–5

Adapted from Sollerman, inter-reliability = 0.980

Sitting, 15 min

Set patient up in sitting at table and have patient perform all 6 tasks for each hand separately

The first phase of item reduction was based on pilot testing and clinical expertise

which rendered the initial GRASSP (Appendix 1 and Table 2), and was used in the cross

sectional study. Further item reduction was conducted by using psychometric analysis to

determine relevance of items and subtests. This stage of item reduction eliminated static two

point discrimination testing, testing for tone, and abductor pollicis brevis from the strength

items. This step rendered GRASSP Version 1.0 (see Appendix 1).

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The GRASSP project includes the entire process associated in the development of the

measure. Table 3 defines the development for each phase.

Table 3: Phases of Development, Objectives and Outcomes for the GRASSP Project Development Phase Objectives Outcomes Phase I – Theoretical Development and Pilot Testing

- Development of the Theoretical Framework - Assembly of the GRASSP Items - Pilot Testing - Item Reduction Based on Linear Regression

Initial GRASSP

Phase II – Cross sectional Study

- Development of Scoring System - Inter/Test Retest Reliability and Construct and Concurrent Validity - Confirmatory Analysis of the Theoretical Framework

- Scoring System Developed and Included in GRASSP Version 1.0 - Inter/Test Retest Reliability, Construct and Concurrent Validity Established - Theoretical Framework Proven to be a Robust Model for GRASSP Development

Legend for Table 3: Bolded sections represent phase of GRASSP Project included in the PhD thesis and conducted by Sukhvinder Kalsi-Ryan.

1.3.2 Description of the GRASSP

The purpose of assembling the GRASSP was to develop a clinical research tool that

could characterize upper limb impairment from the cervical (CO-T1) SCI population, obtain

isolated and integrated sensory and motor impairment data, and define level of impairment

according to the upper limb and spinal cord lesion. The GRASSP was required to: a) be

highly responsive (sensitive) to change over time; b) assess the extent of spontaneous

(natural) recovery; and c) be applicable for use in clinical trials to evaluate the effect of new

therapies. The GRASSP is intended to measure change in neurological status from the acute

to chronic phases of recovery after tetraplegia. The GRASSP is a three domain impairment

measure which contains five subtests and measures each hand separately.

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CHAPTER II: RESEARCH OBJECTIVES & HYPOTHESES

2.1 Significance and Purpose

Upper limb function is of great importance to individuals with SCI (Anderson, 2004;

Snoek, 2004. Specific and precise methods must be implemented to establish efficacy of

methods available to restore upper limb function. However, a challenge that researchers face

is the lack of a precise impairment measure specific to the upper limb after SCI.

Development of the GRASSP was initiated to create an impairment measure to fill this void.

The availability of well developed measures specifically designed to assess the “phenomenon

of interest” is imperative to measure the influence of new interventions. The research

conducted to develop the GRASSP has occurred in two Phases as per Table 3. Phase I

included: development of the theoretical framework, compilation of the items proposed for

the initial GRASSP and pilot testing. Phase II included: item reduction to render GRASSP

Version 1.0, development of the scoring system, psychometric testing, and confirmatory

analysis to determine the design of the theoretical framework.

Items bolded in Table 3 refer to work done by the PhD candidate Sukhvinder Kalsi-

Ryan independent of the larger GRASSP Research and Design Team and items not bolded

represent work done by the GRASSP Research and Design Team collectively. Phase II

represents the work done and included in the PhD thesis.

2.2 Research Objectives and Hypotheses

The content of this thesis establishes the scoring approach and sets initial benchmarks

for levels of GRASSP scores, establishes the psychometric properties of reliability and

validity, and presents relationships of impairment to upper limb function. Additional

objectives and outcomes related to development of the GRASSP are identified in

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Table 3, however, not addressed in this thesis.

2.2.1 Development of the Scoring

The output of a measure is intended to define the phenomenon desired to be measured, in this

case impairment of the upper limb for individuals with tetraplegia. Essentially the score of a

test defines what the state of the phenomenon is. The score or values derived by a measure

should be understandable and represent the state of what they are intended to measure

accurately, so that comparisons with repeated measurement and comparator measures can be

made. If a score is to be cumulated from the items tested, an understanding of what the

cumulated score represents should also be defined. A total score that presents with Guttman

characteristics (Guttman, 1944; Guttman, 1950) predicts item response by knowing only the

total score. Therefore, establishing and understanding the scores of the GRASSP and what

they represented was imperative for the results to be meaningful. Chapter IV presents the

analysis, and results related to the development and explanation of the scoring approach. The

objectives of the analysis in Chapter IV were to:

1) Investigate the cumulative pattern predictability (Guttman pattern) of the items

within each subtest;

2) To identify the discriminative GRASSP score ranges and the associated ISCSCI

levels, AIS classification and SCIM selfcare subscale scores (SCIM-SS); and

3) To determine a method to report GRASSP scores.

The hypotheses were:

H1: Guttman characteristics would not be a dominant pattern of the items

in the GRASSP subtests;

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H2: Discriminative GRASSP scores would not define the sample similarly to ISCSCI

levels, AIS classification and SCIM-SS scores; and

H3: A total GRASSP score would not represent meaningful findings assessed by the

GRASSP subtests.

2.2.2 Psychometric Testing

Psychometric properties of a measure are fundamental qualities which are essential to

establish for a measure to be used in clinical trials and in clinical settings. Therefore,

establishing the reliability and validity of the GRASSP was a necessary process to undertake

in order to qualify the measure for use in clinical and research settings. The objectives of the

analysis presented in Chapter V were:

1) To establish the inter rater and test retest reliability;

2) To establish construct validity using the ISCSCI as a comparator; and

3) To establish concurrent validity with the SCIM and CUE.

Therefore, in Chapter V it was hypothesized that:

H1: The reliability (inter rater and test retest) for all subtests within the GRASSP

would demonstrate an intra class correlation coefficient of at least of 0.80;

H2: The GRASSP sensation and strength subtests would be significantly more

sensitive and precise in defining neurological integrity at the periphery than the ISCSCI

motor and sensory levels; and

H3: The concurrent validity of the GRASSP would be defined by moderate (above 0.6

Pearson correlation coefficient) and significant associations to the CUE, SCIM and SCIM-SS

(this would indicate, as neurological integrity decreases function improves).

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2.2.3 Confirmation of the Theoretical Framework

Assessment of impairment is important to determine the neurological status, but also

important for understanding the relationships between impairment and function. The analysis

presented in Chapter VI explores the relationships between the impairment domains

(sensibility, strength and prehension) as defined by the GRASSP to a latent trait variable of

“sensorimotor upper limb function” and observed functional values (SCIM-SS and CUE) that

represent upper limb function. The objective of the analysis presented in Chapter VI was:

1) to determine the influence of sensibility, strength and prehension impairment on

sensorimotor upper limb function.

Therefore, it was hypothesized in Chapter VI that:

H1: a relationship between sensation, strength and function could be demonstrated

through general linear modeling and structural equation modeling, determining the degree

and type of relationship would provide information to further develop therapeutic

interventions.

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CHAPTER III: GENERAL METHODS SECTION

3.1 Recruitment of Sites and Examiners

All centres were engaged by the members of the GRASSP International Research and

Design Team. Seven centres from Europe and North America were involved in Phase II of

the GRASSP project. Each site engaged two examiners, either occupational or physical

therapists that had experience with the treatment of individuals with SCI. Ethical approvals

were obtained for all sites through local research ethics boards. Fourteen clinicians in total

were engaged in the study (12 occupational therapists and 2 physical therapists).

3.1.1 Training Workshops

All examiners in Europe were trained at a workshop in Zurich, at University Hospital

Balgrist and all examiners in North America were trained at a workshop in Toronto, at the

Toronto Rehabilitation Institute. Workshops consisted of general information regarding the

rationale and study protocol (how the protocol was to be implemented, processes involved in

data management and communications with the central site for assistance and

reimbursement). Demonstration and information regarding the administration of the

GRASSP, ISCSCI, AIS, SCIM and CUE were provided. The examiners were also provided

with the opportunity to perform all measures in the study on individuals with SCI during the

workshop. The workshops were conducted by Sukhvinder Kalsi-Ryan (PhD candidate) in

Toronto and Claudia Rudhe (Clinical Study Nurse) in Zurich.

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3.2 Study Protocol

The GRASSP was the measure of interest and the comparator measures were the

ISCSCI, SCIM and the CUE. The general methodology of the study was designed to address

the testing of reliability and validity of the GRASSP (see Appendix 3 for details regarding

study design).

3.2.1 Outcome Measures

The ISCSCI was selected for use in the study to define the sample according to an

international classification method and to define the severity of injury for individuals

involved in the study. Being the only true measure of impairment for SCI the ISCSCI is the

most meaningful and widely used measure to define SCI and was used as a comparator

measure to establish validity (further details re: ISCSCI are available in Appendix 4). The

SCIM was incorporated into the study to be used as a comparator measure; although, it is a

global measure of independence it is SCI specific and is a well established measure in the

field. The SCIM is a disability scale that has been specifically developed to evaluate the

functional outcomes of patients with traumatic and non-traumatic SCI. The SCIM assesses

function in three core areas: 1) Self-care, which includes feeding, bathing, dressing and

grooming, and is scored between a range of 0 to 20; 2) Respiration and sphincter

management are scored between a range of 0 to 40; and lastly 3) Mobility, also scored

between a range of 0 to 40 (further details re: SCIM are available in Appendix 4) (Catz et al.,

2004). The SCIM was used to provide data to confirm the relationships between impairment

and function. The CUE is a 32 item questionnaire developed to assess difficulty in

performing certain activities with the upper extremities. The CUE is a self perceived measure

of upper limb function which incorporates components of reach, grasp and manipulation. The

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scoring is based on degree of difficultly in performing tasks which is an important domain in

defining functional limitation (Marino et al., 1998). The CUE was selected as a comparator

measure to establish validity and determine relationships between impairment and self

perceived function (further details re: CUE are available in Appendix 4). Properties of the

measures are available in Table 1.

3.2.2 Sample Size

A sample size of 40 individuals was calculated based on an estimated ICC of 0.80 or

greater with an alpha of 0.05. The minimum estimated sample size was 39 for 3 repeated

measures according to Donner & Eliasiw’s estimation curves (Donner and Eliasiw, 1987). As

a result of the multi centre collaboration a greater number of datasets were collected

increasing the sample size to 72 allowing for analysis of item reduction, scoring approach

and impairment/function models.

3.2.3 Inclusion and Exclusion Criteria

Individuals with chronic traumatic tetraplegia who were neurologically (community

dwellers) and medically stable, between the ages of 16 and 65 and able to provide informed

consent were included in the study. Individuals with moderate brain injury who were

neurologically unstable or individuals with any pathology other than tetraplegia causing

upper limb impairment were excluded.

3.2.4 Study Participant Recruitment

Study participants were recruited by the examiners or research coordinators at each

respective site. Study participants were recruited from outpatient programs, programs where

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individuals with chronic tetraplegia were admitted to hospital and the community via

advertisement with SCI specific associations. Potential study participants who met the

inclusion criteria were enrolled consecutively. All participants were screened, informed, and

consented by the research coordinator or examiners.

3.2.5 Study Design

The study protocol in Europe was slightly different from the protocol conducted in

North America. All sites in Europe conducted a protocol which rendered data for inter rater

reliability and construct and concurrent validity. The study participant was assessed twice

with the GRASSP and once with the comparator measures. During the first visit, examiner

one administered the GRASSP. During the second visit examiner two administered the

GRASSP and examiner one administered the comparator measures.

In North America two examiners were engaged at each site. The study participants

were scheduled for two visits. During the first visit examiner one administered the GRASSP

followed by examiner two repeating the administration of the GRASSP. During the second

visit examiner one repeated administration of the GRASSP and examiner two administered

the comparator measures. Examiners were assigned as one and two at each site (see

Appendix 3).

3.2.6 Data Management

All data was de-identified prior to paper entry. All data was initially recorded onto

paper copies of the measures for each study participant. Data collected in Europe were

packaged and couriered to the central site in Toronto, where all data were entered

electronically by the same individual. Data collected in North America were abstracted by

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the respective examiners and entered electronically. All electronic data were transferred to

the central site. All data were pooled to render 72 datasets in total and stored on a secure

server. All analyses were conducted using SPSS 17.0, SAS 9.1 and M-Plus 5.2. Table 4

presents the sample, location of data collection and inclusion for analysis. All data were

collected between January 2007 and September 2007.

Table 4: Description of the Sample and Breakdown of Data received from Participating Sites (presented by n values)

North America

Inter rater

Reliability(n)

Test Retest

Reliability(n)

Construct Concurrent

Validity (n)

Confirmatory Analysis for Theoretical Framework

(n) 1. Rehabilitation Institute of Chicago (Chicago, USA)

10 10 10 10

2. Toronto Rehabilitation Institute (Toronto, Canada)

15 15 15 15

3. Vancouver Coastal Health (Vancouver, Canada)

10 10 10 10

4. Thomas Jefferson University (Philadelphia, USA)

10 10 10 10

Europe 5. University Hospital Balgrist (Zurich, Switzerland)

9 9 9

6. Krakenhaus Hohe Worte (Bayreuth, Germany)

8 8 8

7. Traumacenter Murnau (Murnau, Germany)

10 10 10

Total n Used for Analysis 72 45 72 72

3.3 Sample

A total of 72 datasets were collected. Forty five individuals were enrolled in North

America and 27 were enrolled in Europe. All data was combined for inter rater reliability and

validity analyses. Test retest reliability was established with North American data only.

Tables 5 and 6 describe the European and North American samples separately according to

AIS Classification and ISCSCI sensory and motor neurological levels. Demographic data

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regarding gender, age and time post injury were incomplete across samples therefore; only

ranges for the demographics of age and time since injury were available. However, all data

elements required for all aspects of analysis were consistent among both samples; there were

no missing data elements. The total sample is described according to the ISCSCI sensory and

motor levels and the AIS by frequency histograms in Figure 2. The five figures represent the

motor and sensory levels for both left and right and the classification of injury. Demographic

data and results on comparator measures are summarized in Table 7.

Table 5: AIS Classification of European (n=27) and North American (n=45) Sub Samples (presented in percent and n values) A

% (n) B

% (n) C

% (n) D

% (n) Europe 40(11) 15(4) 19(5) 26(7) North America 37(17) 31(14) 16(7) 16(7) Legend for Table 5: AIS – ASIA Impairment Scale, A – Complete, B – Sensory Incomplete, C – Motor Incomplete, and D – Sensory and Motor Incomplete Table 6: ISCSCI Motor and Sensory Neurological Levels of European (n=27) and North American (n=45) Sub Samples (presented in percent and n values) C2toC4

%(n) C5

%(n)C6

%(n) C7

%(n) C8

%(n) T1

%(n)T2toS5%(n)

Europe 22(6) 15(4) 30(8) 15 (4) 7(2) 11(3) ISCSCI Motor Neurological Level North

America 16(7) 16(7) 31(14) 24(11) 4(2) 9(4)

Europe 48(13) 15(4) 15(4) 7(2) 4(1) 4(1) 7(2) ISCSCI Sensory Neurological Level North

America 49(22) 16(7) 31(14) 2(1) 2(1)

Legend for Table 6: ISCSCI – International Standards of Neurological Classification for Spinal Cord Injury, C2 to S5 – the neurological level according to ISCSCI

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Figure 2: Frequency Histograms Describing ISCSCI sensory and motor levels and AIS Classification for Total Sample (n=72)

Legend for Figure 2: ISCSCI – International Standards of Neurological Classification for Spinal Cord Injury, C2 to S5 – the neurological level according to ISCSCI, AIS – ASIA Impairment Scale, A – Complete, B – Sensory Incomplete, C – Motor Incomplete, and D – Sensory and Motor Incomplete

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Table 7: Demographic, Comparator Measure and GRASSP Results for Total Sample n=72

Demographic Mean SD Range Median

Age * in years 39.7 10.7 16 - 65 42 Time Post Injury *

in years 7.6 6.1 6 months –

20 yrs 6.2

Comparator Measure

SCIM (0-100) 0 – 100 45.1 21.1 11 - 99 38 SCIM-SS 0 – 20 9.8 5.7 0 - 20 9 CUE 0 – 124 78.8 29 4 - 124 78

GRASSP R L R L R L R L Strength 0 – 50 24.3 25.1 13.0 13.5 5-50 1-50 18 19 Dorsal Sensation 0 – 12 6.5 6.7 3.2 3.1 0-12 0-12 6 6 Palmar Sensation 0 – 12 7.1 7.2 3.6 3.3 0-12 0-12 7 7 Prehension Ability 0 – 12 4.9 5.1 4.5 4.3 0-12 0-12 2 2 Prehension Performance

0 - 30 15.6 14.7 9.6 8.9 0-30 0-30 12 12

Legend for Table 7: SD – Standard Deviation, R – right, L – left, *values based on n=42 SCIM – Spinal Cord Independence Measure, SCIM-SS Spinal Cord Independence Measure Self care Subscale, CUE – Capabilities of Upper Extremity Questionnaire

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CHAPTER IV: RESULTS PART 1

4.1 DEVELOPMENT OF THE SCORING APPROACH FOR THE GRADED

REDEFINED ASSESSMENT OF STRENGTH SENSIBILITY AND PREHENSION

(GRASSP)

4.2 Abstract

GRASSP is a clinical impairment measure designed to assess the upper limb

following tetraplegia. Three domains within the GRASSP include five subtests when

administered represent neurological integrity. Defining the numerical values representative of

the spinal cord deficits based on anatomy and defining the predictability of scores through

rank-ordering of the items within subtests was required to give the scoring meaning.

Objectives: 1) To establish the frequency of predictable item response for each subtest

within the GRASSP; 2) to establish the discriminative GRASSP score ranges and compare to

the ISCSCI and SCIM-SS; and 3) to derive a method to present GRASSP scores. Methods:

A cross sectional study was conducted; all participants were tetraplegic and neurologically

stable (n=72). The study protocol included administration of the GRASSP, ISCSCI and

SCIM during the same session. Analysis: Guttman scaling was applied to all items in each

subtest to determine cumulative predictive patterning. The sample was organized by subtest

total (ascending order) for each subtest, in order to establish ranges of GRASSP scores.

Results: All subtests within the GRASSP demonstrated a significant degree of predictable

item response based on the Guttman matrices; predictable item response ranged between

78% and 90% for the five subtest total scores (dorsal sensation, palmar sensation, strength,

prehension ability and prehension performance). GRASSP score ranges were defined

according to spinal cord levels (rostral to caudal) which were not congruent with the

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discrimination of levels derived by the ISCSCI sensory and motor testing, however, similar

to the discrimination of scores derived by the SCIM-SS total. The five subtest scores were

cumulative in nature, therefore, a cluster bar graph of subtest total scores was used to present

GRASSP results. Conclusion: Items within each of the five subtests can be added and

defined by subtest total scores. The subtest total scores are interpreted to mean more

impairment or less impairment when moving from a lower numeric value to a higher numeric

value respectively. Subtest total scores can be interpreted by way of a cluster bar graph.

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4.3 Introduction

It is recognized that there is a deficiency of adequate outcome measures for the

assessment of impairment of the upper limb for individuals with tetraplegia (Dunn et al.,

2008; Miller et al., 2008; van Tuijl et al., 2002; Curtin et al., 2005). Due to this deficiency

many researchers are faced with the challenge of using inadequate outcomes to follow

neurological recovery post tetraplegia. Due to the fact that impairment is not usually the

construct measured in existing assessments, definitive relationships between impairment and

function remain a phenomenon that is not well understood.

Impairment of the upper limb is extremely important to understand and measure in

order to progress the development of new restorative techniques. In order to measure upper

limb impairment there are a number of components and subcomponents which need to be

considered as part of the measure. There are specific neural and musculoskeletal subsystems

which contribute to the control of upper limb function (Shumway-Cook and Woollacott,

2007). Impairment of the upper limb must be measured by multiple domains to be

comprehensive. Assessing the impairment of the upper limb with precision is the first step in

determining the contribution of impairment to function. Thus, the representation of

impairment should define the construct in this case “sensorimotor upper limb function” with

numeric values which have context.

The ISCSCI (Marino, 2000) is a diagnostic measure used to define the severity of

SCI, by defining the most caudal level of normal neurological spinal cord function. The

ISCSCI does not measure the upper limb comprehensively, particularly sensation of the

palmar surface of the hand. As ISCSCI was not intended to be used as a measure of upper

limb impairment, a new approach was required. Therefore, in an effort to respond to this gap

in available impairment outcome measures, the GRASSP was developed (Kalsi-Ryan et al.,

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2009). The GRASSP is a clinical measure of upper limb impairment which can be

administered in a clinical setting and incorporates three domains that are vital to upper limb

function: sensibility (sensation), strength (motor) and prehension. The GRASSP includes

Semmes Weinstein Monofilament (SWM) testing on both the dorsal and palmar surface of

the hand, motor testing of 10 muscles of the hand and arm, performance of three prehensile

positions (grasps) and performance of six task oriented prehension skills. Figure 3 presents a

summary of the domains, subtests and items of the GRASSP.

Figure 3: GRASSP (Components) Version 1.0

Figure 3 presents the domains, 5 subtests, items and scoring.

The GRASSP was developed to contain more than one domain to accommodate the

multiple elements related to upper limb impairment in tetraplegia. Three domains are

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represented by five subtests with each subtest containing up to ten items. Right and left hands

are tested separately, resulting in five subtest results for each hand. Because the response

range for items among subtests is not consistent, defining the meaning of GRASSP subtest

scores through the process of scaling was required in order to determine the optimal and most

meaningful method of presenting the responses. The separate domains (sensation, strength

and prehension) are not intended to have internal consistency, instead they have definitive

contributions and interactions with one another as well as to overall upper limb function.

Figure 1 in Chapter 1 presents the theoretical framework which defines the concepts,

theories, construct and domains considered when designing the GRASSP. Therefore, adding

scores across subtests for a global score would not represent the multi dimensional construct

of “sensorimotor upper limb function” adequately. Attention to the scoring system and best

possible options for use are significant in development of the measure as a whole, however,

the meaning of individual subtest total scores is of greater significance to defining

neurological deficit than a single global score. The manner in which the scoring approach is

defined should reflect the deficit as close as possible (Samejima, 1969). When there are,

numerous domains within a single measure and numeric values are used to represent

neurological integrity, development and explanation of the scoring approach is a

requirement.

Measurement refers to the assignment of objects to numbers according to a rule

(Stevens, 1946). Guttman scaling (Guttman, 1944; Guttman, 1950) is one method used in

developing a measure. The Guttman scaling methodology was applied to each subtest for the

interpretation of the numeric values derived by the response items, in order to establish a

continuum for the concept that was being measured. Essentially, determining a scale to have

Guttman characteristics means that the total score is predictive of the order of item response

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(Trochim, 2010). Guttman scaling is traditionally applied to dichotomous variables to

determine whether a set of items can be rank-ordered on a one-dimensional scale. However,

the concept can be applied to polychotomous variables (van Schuur, 2003) as well. The

process creates a scale where, when the second item response is positive, the preceding

response would also be positive. With polychotomous variables the process creates a scale

where, when the response is at a specific level, each preceding variable has a response of the

same level or close to it. There is some variation due to the complexity of polychotomous

variables. However, establishing a polychotomous scale to show a Guttman pattern means

that the scale predicts item response based on the total score. The total cannot be predictable

of item response 100% of the time. However, awareness of the frequency of a predictable

pattern provides insight to the examiner as what a subtest total score should mean and what it

could mean. Rasch analysis is one statistical method that can be used to determine the

predictable pattern of item response in a unidimensional scale (Norquist, et al., 2004),

however, a rather large sample size is required to conduct this analysis. Mokken Scale

Analysis is another statistical method that can be used with both dichotomous and

polychotomous variables to determine predictability of item response, again a large sample

size (at least n=200) (van Abswoude et al., 2004) is required for this analysis. Therefore,

Guttman scaling was performed manually.

Known group’s method is a typical method to support construct validity and is

provided when a test can discriminate between groups of individuals known to have differing

levels/severity of a trait (Portney and Watkin, 2000), in this case severity of SCI. In the initial

work done to establish known groups for the GRASSP, ranges of GRASSP subtest scores

were benchmarked against the ISCSCI sensory and motor levels and SCIM-SS. The purpose

of this step was to define the place of GRASSP scores against a known measure of

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impairment (ISCSCI) in SCI and a known functional measure (SCIM-SS) specific to SCI.

The ISCSCI assigns impairment according to the most caudal “normal” neurological level;

any sensory and motor function below the designated level is not accounted for except by the

zone of partial preservation which is also a sensory or motor level. Therefore, the ISCSCI

does not provide a true representation of impairment measured over the body. Using ISCSCI

to identify levels of GRASSP scores would not provide distinct groupings, only ranges,

whereas the GRASSP impairment measure accounts for the partial neurological status

between neurological levels, by presenting the deficit as a numeric value which represents

impairment or lack there of in the upper limb.

Based on the available measures in the field and the available sample, the scoring

system was developed with Guttman scaling and benchmarking ranges of GRASSP scores to

well known standards used in the field. The three objectives addressed in this chapter were:

1) to establish the frequency of predictable item response for each subtest within the

GRASSP; 2) to define the meaning and ranges of GRASSP subtest total scores according to

the ISCSCI and SCIM-SS; and 3) to define the methodology that would be used to interpret

GRASSP scores.

4.4 Methods

Ethical approval was attained at all institutions participating in the study. Seven

centres participated in the trial (three European and four North American). Data was

collected on a cross section of individuals with chronic traumatic tetraplegia, who were

medically and neurologically stable, and able to provide informed consent (n=72).

Individuals with moderate brain injury and/or any other pathology affecting the upper limb

were excluded. Sample size calculation was based on an estimated intra class correlation

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coefficient of 0.80 or greater with an alpha of 0.05. The minimum estimated sample size was

39 for 3 repeated measures according to Donner & Eliasiw’s estimation curves (Donner and

Eliasiw, 1987). Due to the multi-national collaboration 72 datasets were collected. Two

workshops (one in Europe and one in North America) were conducted to train the examiners

regarding the study protocol and appropriate use of all study measures. Instructions and

demonstrations in the administration of the primary measure, GRASSP and secondary

measures, SCIM, ISCSCI and the CUE were provided to all examiners. All data were de-

identified and sent to the central site from all participating centres where it was aggregated.

European and North American data was pooled to render 72 data sets.

Analytic Plan: A priori the following was hypothesized: 1) a cumulative predictive

pattern of response items would not exist thereby causing the developers to establish an

alternative method for summating subtest scores to present results; 2) subtest total scores

would define groups of the sample according to upper limb impairment, not necessarily

according to level of lesion as designated by ISCSCI; and 3) a method to present and

interpret the results of the GRASSP scores would be derived.

Guttman scaling methodology (see Appendix 5 for details of method used) was

applied to the five subtests and the items within (dorsal sensation, palmar sensation, strength,

prehension ability and prehension performance) separately. With the number of items in each

subtest being small and the sample being relatively small for this type of analysis, the rank-

ordering was done manually. Guttman scaling was performed by: 1) re-ordering the items in

each subtest to reflect spinal cord levels (anatomy, rostral to caudal) 2) matrices were

constructed for each subtest and the items within which displayed all responses for the total

sample and each matrix was sorted so that individuals who responded with more impairment

were moved to the top and those with less impairment were moved to the bottom (Trochim,

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2010). See Table 8 for an example of the process and Appendix 5 for all matrices. The

process was repeated until all individuals in the sample fit a pattern of cumulative

predictability; individuals that did not show cumulative predictability were considered the

“exceptions” and were separated (matrices for all five subtests are available in Appendix 5).

Cumulative meaning items that were rostral anatomically were intact prior to more caudal

items being intact. When the process was complete the matrices showed a cumulative pattern

when read from left to right across the columns (items) for each individual. The frequency of

cumulative pattern predictability determined whether the subtest scale could be used as a

cumulative score and interpreted to have item prediction.

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Table 8: Example of Guttman Scaling Using Scores of Palmar Sensation Items Table 8 illustrates the Palmar Sensation (PS) item and total scores of the first 60 of 72 individuals in the sample. The table on the left side presents the sample as the data was entered and the table on the right side presents the sample ordered by cumulative predictability of the item scores, with descending order of less impairment. This process was repeated for all five subtests.

Subtest total scores were placed in ascending order to establish the ranges of

GRASSP scores and associated with ISCSCI sensory and motor levels, zone of partial

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preservation scores, AIS classification and SCIM-SS. Table 11 defines the item scores and

ranges, the subtest total scores and ranges for each subtest and the meaning of ranges within

the scores. The numeric value derived from the subtest total score was intended to represent

the neurological integrity of the upper limb which would represent the spinal cord levels

secondary to the dematomal and myotomal patterns followed. For example, if the total

possible score for dorsal sensation is 12, the meaning of the numeric value would be as

follows: 0-4 would represent any degree of innervation between C5 and C6 with 4

representing normal sensation of C6, 5-8 would represent normal C6 innervation and any

degree of innervation between C6 and C7 with 8 representing normal C7 sensation and so on

and so forth. Therefore, the range of numeric values represents a neurological level of

sensation with the lower end of the range representing more deficit and the higher end of the

range representing less deficit.

4.5 Results

Sample - The data used in this analysis included a multi centre/multi national cross

section with the total sample consisting of 72 individuals with chronic tetraplegia ranging

from 6 months to 20 years post injury. Distribution of the sample according to the ISCSCI is

defined in Table 9. Approximately 52.5% of the individuals fell into the C6 - C7 motor level

group and approximately 66% fell into the C4 - C6 sensory level group. The AIS indicates

that approximately 61.1% of the sample was incomplete.

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Table 9: Demographics of the Sample Based on ISCSCI sensory and motor levels and AIS Classification, n=72 (presented as n values and percentages of sample)

ISCSCI Levels Motor Level

n (%)

Sensory Level

n (%)

AIS Classification

n (%) Right Left Right Left A B C D

C2-C4 10 (14) 14 (19) 29 (40) 29 (40) C5 10 (14) 9 (13) 11 (15) 9 (13) C6 23 (32) 21 (29) 17 (24) 19 (26) C7 17 (24) 16 (22) 8 (11) 6 (8) C8 4 (5) 5 (7) 1 (2) 2 (3)

T1 and below 8 (11) 7 (10) 6 (8) 7 (10)

28 (39)

18 (25)

12 (17)

14 (19)

Legend for Table 9: ISCSCI – International Standards for Neurological Classification of Spinal Cord Injury, AIS – ASIA Impairment Scale

The Guttman Scaling process defined the frequency of cumulative predictability for

each subtest and Table 10 defines the predictable and non-predictable portions of the sample.

The characteristics of the individuals as designated by the ISCSCI sensory and motor levels,

AIS and zone of partial preservation scores are also defined for the predictable and non

predictable portions of the sample. The portion of the sample that showed cumulative pattern

predictability in the subtest items were not defined by any specific characteristics according

to the ISCSCI and AIS designations, although the portion of the sample that showed non-

predictive patterning did reveal some characteristics as defined by the ISCSCI and AIS.

Individuals with non-predictive patterning of palmar sensation were incomplete (B, C or D).

Individuals with non-predictive patterning of strength tended to have normal strength in the

upper cervical region. The remaining subtest non-predictable patterning portions of the

sample did not present with any specific and distinct characteristics according ISCSCI and

AIS designations.

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Table 10: Portion of Sample which presented with and without a Cumulative Predictive Pattern for each Subtest Total Score in the GRASSP (presented by n value and percentage of sample) Subtest Predictive

N (%)

ISCSCI Characteristics of

Predictive

Non-Predictive

N (%)

ISCSCI Characteristics Non-Predictive

AIS S/M Level

ZPP AIS S/M Level

ZPP

Dorsal Sensation

63 (87) A-D C4-T1 C5-C8 9 (13) A,B,C C4-T1 C8

Palmar Sensation

65 (90) A-D C4-T1 C5-C8 7 (10) B,C,D C5,C6 C8

Strength 56 (78) A-D C4-T1 C5-T1 16 (22) A-D C4-C7 C6-T1

Prehension Ability

59 (82) A-D C4-T1 C5-T1 13 (18) A-D C6,C7, T1

C6, C7, T1

Prehension Performance

60 (83) A-D C4-T1 C5-T1 12 (17) A,B,C C6,C7, C8

C6, C7, C8

Legend for Table 10: ISCSCI – International Standards for Neurological Classification of Spinal Cord Injury, AIS – ASIA Impairment Scale, Predictive – Group of sample with cumulative predictive pattern; Non-predictive - Group of sample without cumulative predictive pattern (exceptions); ZPP – Zone of Partial Preservation Score; S/M Level – Sensory or Motor Level as designated by ISCSCI Shaded cell is referred to in the discussion

During development of the GRASSP, items that were included represented

dermatomal and myotomal patterns (Moore, 1985). Therefore, items a priori had or

represented a degree of neurological integrity. The values in Table 11 define the subtest

scores, ranges and the intended meaning of scores based on their representation of the spinal

cord. Each subtest had ranges within it that represented neurological integrity of the upper

limb as defined by the state of deficit in the peripheral limb. Because the location of anatomy

assessed is associated to spinal cord levels the peripheral representation also defines spinal

cord level. However, the range between levels was also accounted for by the GRASSP. In the

case of the strength subtest total score (50) a total score between 0-9 represents innervation

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rostral to C5 and 10 represents C5 innervation, 11-15 represents innervation between C5 and

C6 and 15 represents C6 innervation and so on and so forth. The intended meaning of scores

which are defined for all the subtests and a glossary for what the numeric values should

represent is provided. These ranges of scoring are based on the items and associated

dermatomes and myotomes. It was not determined how often the scores represented their

intended meaning, with the limited sample. However, it was certain at this stage of score

development that an increase in subtest total score value represented: 1) an increase in

neurological integrity or decrease in deficit, and 2) the increase was moving in the direction

from rostral to caudal approximately 80% of the time with this specific sample.

ISCSCI motor and sensory level designations, AIS and zone of partial preservation scores

were also used to benchmark the ranges of GRASSP scores. The ISCSCI and AIS did not

discriminate the levels of GRASSP scores similarly. The difference in groupings was

predominantly due to the method in designation of levels and scores. The SCIM-SS was also

used to benchmark the levels of GRASSP scores as it represented upper limb function. The

SCIM-SS did provide more definitive groupings in relation to the GRASSP subtest scores.

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Table 11: ISCSCI Sensory and Motor Levles and SCIM-SS Benchmarks for GRASSP Discriminative Score Ranges Subtest

# of items, item score range subtest score range

Intended Meaning of Score (levels of GRASSP scores)

SCIM-SS Score

ISCSCI and AIS Classification S or M Level ZPP

Dorsal Sensation 3, 0-4 0-12

0-4 – C6 5-8 – C7 9-12 – C8

0-10 5-15 10-20

A-D A,B,D A-D

C4-C7 C4-C7 C4-T1

C4-C8 C7-C8

C8 Palmar Sensation

3, 0-4 0-12

0-4 – C6 5-8 – C7 9-12 – C8

0-10 5-15 10-20

A,B,D A-D A-D

C4-C6 C4-C7 C4-C8

C5-C8 C7-C8

C8 Strength 10, 0-5 0-50

0-10 – C5 11-15 – C6 16-25 – C7 26-40 – C8 41-50 – T1

0-5 5-10 5-15 10-20 10-20

A A,B

A,B,C B,C,D B,C,D

C4-C5 C4-C6 C6-C7 C4-C8 C6-T1

C5-C7 C5-C7 C6-C8 C7-T1

T1 Prehension Ability

3, 0-4 0-12

0-6 – C5-C6 7-12 – C7-T1

0-10 11-20

A-D A-D

C4-C7 C7-T1

C5-C8 T1

Prehension Performance 6, 0-5 0-30

0-5 – C5-C7 6-10 – C5-C7 1-15 – C5-C7 16-20 – C5-T1 21-25 – C5-T1 26-30 – C5-T1

0-10 0-10 0-10 11-20 11-20 11-20

A A,B

A,B,C A,B,C B,C,D A-D

C4-C5 C5-C7 C5-C7 C6-C8 C6-C8 C5-T1

C5-C7 C6-C7 C6-C8 C7-T1 C7-T1

T1 Legend for Table 11: ISCSCI – International Standards for Neurological Classification of Spinal Cord Injury, AIS – ASIA Impairment Scale, SCIM-SS – Spinal Cord Independence Measure Selfcare Subscale, ZPP – Zone of Partial Preservation Score; S or M Level – Sensory or Motor Level as designated by ISCSCI, AIS – Classification (A,B,C,D), Shaded cells are referred to in the discussion.

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4.6 Discussion

The GRASSP is an impairment measure for the upper limb after tetraplegia which

includes three domains (sensation, strength and prehension) and five subtests. Each subtest

includes anywhere from three to ten items with various item ranges and all item response

ranges are polychotomous. The GRASSP was designed so that numeric values would

represent impairment; a numeric value of zero or close to zero represents more deficit and a

numeric value close to or at the maximum value represents less or no deficit.

Because impairment is being represented by numeric values it was essential to define

the meaning of the numeric values that are rendered by the GRASSP. Items for each subtest

were generated to ensure there was representation of all spinal cord levels with at least two

items. Although it was not expected that such a strong representation of an anatomical

pattern would be seen in the GRASSP results, it was present. The initial part of score

development for the GRASSP entailed the process of determining the scale characteristics.

Frequency of cumulative pattern predictability for each subtest was used to determine if the

subtests presented with Guttman characteristics. All five subtests within the GRASSP

presented with Guttman characteristics when the items were ordered according to spinal cord

anatomy. The Guttman pattern mimicked the anatomical spinal cord levels moving from

rostral to caudal for the sensation and strength domains. Therefore, incorporating the

anatomical concepts in the development of the GRASSP has provided a basis to understand

the cumulative numeric values; however, it is not the only factor in interpretation of the

scores because the impairment and numeric values are derived over the upper limb. The

numeric values have some merit in representing the level of spinal cord integrity;

nonetheless, they also represent the neurological integrity over the upper limb which may not

be a one to one correlation to the level of injury. Thus numeric values should be considered

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as general representations of the level of innervation at the spinal cord as per Table 11 and

the value should be interpreted as a portion of normal sensory or motor function. For

example someone with six out of twelve for palmar sensation would have about half of the

normal sensation in the hand and it would be C6 to partial C7 innervation.

Ideally, if a larger sample were available, Rasch analysis or the Mokken Scale

Analysis would be more appropriate methods to determine the predictability of item

response. Therefore, the sample size is one limitation of this particular analysis. However,

this work does provide the preliminary evidence to proceed with a Rasch or Mokken Scale

Analysis when the available sample is large enough.

When interpreting subtest total scores for dorsal sensation, palmar sensation, strength,

prehension ability and prehension performance a score closer to zero represented more

deficit, while a score closer to the maximum represented less deficit. These numerical values

when interpreted according to Table 11, enable the assessor to understand the general degree

of impairment an individual would possess.

In addition, the ISCSCI characteristics of the individuals who did not demonstrate

cumulative predictable patterning were still presented so that there is an understanding that

subtest totals were only predictable approximately 80% of the time. Subtest totals

represented the individual with enough predictability that the numeric value could be

interpreted to represent level cumulativeness (rostral to caudal). The remaining 20% of the

time the pattern was unpredictable. Since the ISCSCI designated sensory and motor levels

according to the most normal caudal level of innervation, ISCSCI levels did not definitively

define the predictable and non predictable groups. However, classification at times defined

the unpredictable individuals. For individuals who were incomplete (B, C, D), palmar

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sensation was manifested in a less predictable pattern; similarly for individuals that were A,

B or C, strength and prehension were also manifested in a less predictable pattern.

Since cumulating the subtest items was qualified by the scaling process, the total

subtest scores were also benchmarked for the first time. Table 11 presents the range of each

item and subtest total. Ranges of the subtest totals were intended to represent specific sensory

and motor levels (both partial and full) numerically. The intended meaning of the numeric

values, otherwise known as the levels of GRASSP scores are presented in Table 11. Ranges

of GRASSP scores do show some congruency with SCIM-SS groupings which represent

upper limb function. Function is more discriminative at the upper and lower cervical ranges

of tetraplegia whereas the scores and levels that represent the mid-cervical region tend to be

less discriminative. This is seen in both the sensation and strength data. The group of

individuals with sensation that generally represent C6 innervation or rostral to that (0-4)

generally score between 0-10 on the SCIM-SS. The group of individuals with sensation that

generally represents C7 to C8 innervation (9-12) generally score between 11 and 20 on the

SCIM-SS The group of individuals with sensation that generally represents C6 to C7

innervation score on the SCIM-SS somewhere in between those two distinct groups (5-15).

In the strength scores we see something similar where the upper and lower cervical levels of

innervation (C5, C8, T1) are more discriminative with SCIM-SS scores than the mid-cervical

levels of innervation (C6, C7).

Due to the fact that subtest items can be added for subtest total scores and cannot be

added up across subtests the most meaningful way to observe GRASSP subtest totals is to

plot the scores on a cluster bar graph for each hand. Scores are normalized before they are

plotted on the graph. Normalizing the subtest scores before combining was a method

employed by Rosen and Lundborg in the development of a multi-domain measure for

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peripheral hand injury (Rosen and Lundborg, 2003). Figure 4 illustrates three individuals

from the sample (right hands only) and the associated subtest scores. This method allows one

to view multiple individuals or repeated measures of the same individual collectively in one

diagram. Scores defined in this method enable the assessor to make comparisons over time.

Figure 4: A Visual Representation of GRASSP Subtest Scores

Figure 4 illustrates three representative cases from the sample. The legend defines the ISCSCI sensory/motor/AIS scores for the right side only. In summary, items of each subtest can be summated; approximately 80% of the time

the scores follow a cumulative predictive pattern which means the subtest total is cumulative

across spinal cord levels rostral to caudal. Individual ranges of subtest total scores represent

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innervation according to spinal cord level and a percent of the total score established during

development of the measure.

The discriminative GRASSP score ranges in some cases better reflect neurological

status; specific subtests within the GRASSP reflect impairment better than other subtests. For

example as the ISCSCI sensory and motor level is more caudal the scores of the GRASSP

strength subtest tend to increase, see Table 11. Table 10 shows that individuals who present

with a non predictable pattern for palmar sensation tend to be incomplete (B, C or D). SCIM-

SS divisions tend to represent levels of GRASSP scores more discriminatively for the dorsal

and palmar sensation and strength subtest scores, see Table 11. It will be important with a

larger sample to see if these trends are confirmed as definitive known groups in the future.

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CHAPTER V: RESULTS PART 2

5.1 THE GRADED REDEFINED ASSESSMENT OF STRENGTH SENSIBILITY AND

PREHENSION (GRASSP) – RELIABILITY AND VALIDITY

5.2 Abstract

With the advent of new interventions targeted at both acute and chronic SCI, it is critical

that techniques and protocols are developed that reliably evaluate changes in upper limb

impairment/function. The GRASSP protocol, which includes five subtests, is a quantitative

clinical hand impairment measure designed for use in acute and chronic SCI. Objectives of the

study were to: 1) establish the inter rater and test retest reliability and 2) establish the construct

and concurrent validity with the ISCSCI, SCIM and the CUE. The study protocol included

repeated administration of the GRASSP on a cross section of individuals with tetraplegia who

were neurologically stable (n=72). Two examiners assessed the individuals over a seven day

period; a complete ISCSCI, CUE and SCIM were also administered. Reliability was tested with

intra class correlation coefficients; construct validity was established by comparing the value of

the additional components in the GRASSP to the ISCSCI, and concurrent validity was tested

with Pearson correlation coefficients. Inter rater and test retest reliability for all subtests within

the GRASSP were above the hypothesized value of 0.80 (0.83-0.96 and 0.86-0.99, respectively).

Construct validity was confirmed by discordance of the sensibility and strength subtests within

the GRASSP; the subtests showed concurrence with the SCIM, SCIM self-care subscale and

CUE. Impairment revealed the strongest concurrence with self perception of function (0.57-0.83,

p < 0.0001). The GRASSP demonstrates reliability, and construct and concurrent validity for use

as a standardized upper limb impairment measure for individuals with tetraplegia.

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5.3 Introduction

Individuals with tetraplegia, researchers and society in general acknowledge that residual

hand and upper extremity function are critical determinants of independence for people with

tetraplegia (Anderson, 2004; DeVivo, 1997). As a result, any gain in arm and hand function is

important to enhance quality of life (Anderson, 2004; Snoek et al., 2005) for this population. For

this reason, there are many concentrated efforts towards the development of methods to restore

upper limb function after spinal cord injury (SCI) (Popovic et al., 2006; Taylor et al., 2002;

Prochazka et al., 1997). Scientists conducting research in SCI report that there is a lack of

appropriate outcome measures for the assessment of impairment and function for the upper limb

after cervical SCI (Dunn et al., 2008; Miller et al., 2008; van Tuijl et al., 2002). Researchers are

faced with the challenge of using inadequate outcomes to prove efficacy of novel interventions

and as a result, measures that are non-specific to tetraplegia are common limitations in efficacy

studies using new therapies (Prochazka et al., 1997; Fujiwara et al., 1999; Kohlmeyer et al.,

1996).

The upper limb acts as a kinetic chain with the proximal joints, placing the more distal

ones in space for prehension and manipulation of the environment (Kapandji, 1970). The

components of upper limb function are defined as reach, prehension and manipulation

(Shumway-Cook, 2007; Brand and Hollister, 1999). However, no single method of assessment

has been developed to capture these impairments in a manner sensitive to small but important

changes that might occur as treatment in SCI advances. Acknowledgement of the integration of

levels of impairment into functional tasks is important for individuals with tetraplegia as many

adaptive techniques make use of available motor and sensory power to execute a task.

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Concurrently, there is no agreed upon outcome that captures the sensory, motor and functional

findings in a manner that will be sensitive to neurological change in these patients.

The need for a sensitive battery is more important because of two main factors. First,

there is now greater potential for neurological recovery as there are an increasing proportion of

incomplete injuries; almost 50-60% of SCI are incomplete (Marino et al., 1999; Sekhon and

Fehlings, 2001). Second, novel interventions are also targeting a means to enhance neurological

recovery and require outcomes that can substantiate these gains in order to prove efficacy

(Steeves et al., 2007).

Although a number of researchers throughout the world have been working on the

development of upper limb measures specific to the SCI population, the measures developed are

predominantly functional tests of capacity. The Link Hand Function Test (Link, 2004) and the

Van Lieshout Test (Post et al., 2006) are quantitative functional tests for the upper limb. The

Grasp and Release Test (Smith et al., 1996) and the Toronto Rehab Hand Function Test (TR-

HFT) are also tests of capacity, but are specifically designed to evaluate outcomes after

functional electrical stimulation (Popovic et al., 2006). The TR-HFT is the only test which

evaluates stereognosis through the tasks. All of these tests are useful during the post acute and

rehabilitation phases, however, they are not feasible for use in the acute phase when subtle

changes in impairment are critical to establish the relationships of multiple interventions. Due to

the fact that impairment represents the subsystems which comprise the components of upper

limb function (reach, prehension and manipulation), assessing the impairment is an important

factor in defining what subcomponent of upper limb function is affected by an intervention

and/or natural recovery.

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Measuring hand impairment and function post injury is complex and dependent on

multiple factors such as the interaction between the sensory and motor aspects of movement. The

ISCSCI (Marino, 2000) is the current standard used to assess recovery after SCI by designating

the most normal caudal level of sensory and motor functioning. The ISCSCI classifies by

normal spinal cord level and in doing so, may be relatively insensitive to measure upper limb

impairment in a manner that can quantify change. An outcome measure that is sensitive and

responsive to change is warranted; one that can be used to determine the extensive individual

variability in sensory and motor change post injury. This measure should be able to track the

natural history of recovery and the response of individuals receiving treatment.

The GRASSP was developed by a team of six researchers to fill this void and in 2006 the

International GRASSP Research and Design Team was brought together to establish an upper

limb impairment measure. The GRASSP is a clinical measure of upper limb impairment which

incorporates three domains vital to upper limb function: sensibility (sensation), strength (motor)

and prehension (grasp and pinch). During the theoretical development of the GRASSP an

anatomical, neurophyisological and functional approach were incorporated into all domains

included. Sensory elements which represented physiology and function were incorporated

including palmar test locations and a sensory modality with well established measurement

properties (Mackin et al., 2003). Motor elements with a stronger representation of neurological

levels (Moore, 1985) and an increased number of muscles tested per myotome were included to

enhance accuracy and precision of the measure. In order to ensure that the presence (absence) of

movement of the hand during the early stages post injury was not missed, a prehension ability

test of three grasps was incorporated. A prehension performance test was incorporated to make

certain that movement was assessed within a functional paradigm and to determine how

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movements were performed and contextualized. The GRASSP includes Semmes Weinstein

Monofilament (SWM) testing on the dorsal and palmar surface of the hand, motor testing on 10

muscles of the upper limb (three arm, seven hand), performance of three prehensile positions and

performance of six task oriented prehension skills. All tests are graded using a scoring system

that focuses on how movement is performed. Each subtest renders a total score which can be

used for comparison with corresponding subtest scores and the use of a cluster bar graph has

been employed for reporting results of repeated measurements. Please see Figure 5 for a

summary of the components of the GRASSP and an example of the current scoring system.

The GRASSP has been developed in stages. The overall objective was to develop a

comprehensive outcome measure capable of the following: able to assess upper limb

impairment/function that is responsive to change, able to assess the extent of natural recovery

over the acute to chronic phases, capable of being used in both clinical research, and the

evaluation of novel interventions. Development has also included evaluation of the psychometric

properties of reliability, validity and responsiveness. Theoretical and clinimetric development of

the GRASSP including the rationale and analysis used to determine inclusion of subtests has

been previously reported (Kalsi-Ryan et al., 2009). The three objectives addressed in this

manuscript are: 1) to establish the inter rater and test retest reliability of the subtests within the

GRASSP; 2) to establish the construct validity (agreement and discordance of GRASSP) against

the ISCSCI and 3) to establish the concurrent validity of the GRASSP with the SCIM (Catz et

al., 2004) and CUE (Marino et al., 1998).

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Figure 5: Summary of GRASSP Components

Figure 5 presents the domains, items, scores and global scoring.

Although, the ISCSCI is not specific to the upper limb, it was selected because of its use

as a primary outcome measure in many SCI studies. The SCIM was selected as a measure of

function and independence for comparison to the impairment elements in the GRASSP. The

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CUE was selected as a self-perceived measure of function due to the fact that consumer input in

terms of an individual’s own evaluation of their functional status is becoming increasingly

important in the field (Anderson, 2004). Although the measures selected for validity comparison

do not share the same constructs as the GRASSP, these measures were the only available

measures with well established psychometric properties.

5.4 Methods

Ethical approval was attained at all institutions participating in the study. A cross-

sectional multi centre trial was conducted to establish the reliability and validity of the GRASSP.

Inclusion/Exclusion: Individuals with chronic traumatic tetraplegia who were neurologically and

medically stable, between the ages of 16 and 65 and able to provide informed consent were

included in the study. Individuals with moderate brain injury who were neurologically unstable

or individuals with any other pathology causing upper limb impairment were excluded from the

study. A sample size of 40 people was calculated based on an estimated ICC of 0.80 or greater

with an alpha of 0.05. The minimum estimated sample size was 39 for 3 repeated measures

according to Donner & Eliasiw’s estimation curves (Donner and Eliasiw, 1987). As a result of

the multi centre collaboration a greater number of datasets were available, allowing the n value

to increase to 72.

Seven centres participated in the trial (3 European and 4 North American). Two

workshops (one in Europe and one in North America) were conducted to train the examiners

regarding the study protocol and appropriate use of all study measures. Instructions and

demonstrations on the administration of the primary measure, GRASSP and secondary measures,

SCIM, ISCSCI and CUE were provided to all examiners. Training was provided to reduce the

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observer variability (Wright and Feinstein, 1992). The protocol conducted in Europe consisted of

two examiners assessing each study participant once; during the first visit examiner one

administered the GRASSP and during the second visit examiner two administered the GRASSP

and all secondary measures. European data was used in the analysis to establish inter rater

reliability and validity.

The protocol conducted in North America consisted of two examiners assessing each

study participant a total of three times. During the first visit examiner one and two administered

the GRASSP approximately one hour apart and during the second visit examiner one

administered the GRASSP and all of the secondary measures. North American data was used in

the analysis of inter rater, test retest reliability and validity. The European and North American

data was pooled to render 72 data sets for the analysis of inter rater reliability, construct and

concurrent validity. Forty five data sets were used for the analysis of test retest reliability. All

data were de-identified, entered into excel tables and sent to the central site. Data was aggregated

and analyzed using SAS 9.1.

Analysis – A priori we anticipated the following: 1) Inter rater and test retest reliability

for subtest scores would be greater than or equal to an ICC value of r=0.80. According to

Streiner and Norman, reliability is considered to be good if the ICC is above 0.75 (Portney and

Watkin, 2000; Steiner and Norman, 1995). 2) Construct validity (Patrick and Erickson, 1993;

Steiner and Norman, 1995) would be demonstrated by GRASSP sensibility and strength subtests

defining sensory and motor impairment with only a slight to moderate agreement when

compared to the ISCSCI.

Reliability was analyzed by conducting intra class correlation coefficients for non-

parametric variables with a two-way random effect on the GRASSP subtest total scores (Portney

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and Watkin, 2000). The GRASSP was designed to have a broader range of items and response

levels related to the upper limb in comparison to the ISCSCI, therefore, it would be expected that

the GRASSP sensibility and strength subtests and items would define the sample with greater

accuracy. Construct validity was analyzed by comparing the descriptive frequency data of the

ISCSCI sensory and motor test items with the corresponding GRASSP subtest items. Instead of

comparing total scores or levels derived, item comparisons were conducted to ensure summed

data did not influence results. Kappa coefficients were also conducted in the sensory

comparisons to determine the degree of agreement and discordance between both measures.

Agreement is established by the following standards as established by Landis and Koch: [ .00 -

poor, .01-.20 – slight, .21-.40 – fair, .41-.60 – moderate, .61-.80 – substantial and .81-1.00 –

almost perfect (Landis and Koch, 1977)]. Concurrent validity was analyzed by conducting

Pearson correlation coefficients between GRASSP subtest scores with SCIM total scores, SCIM

SS, and CUE scores. The a priori hypothesis was that concurrent validity with functional tests

would be demonstrated by a moderate association of GRASSP subtest scores with the SCIM,

CUE, and SCIM-SS.

5.5 Results

Sample - The data used in this analysis included a multicentre/multinational cross section of data;

the total sample consisted of 72 individuals with chronic tetraplegia ranging from 6 months to 20

years post injury. Distribution of the sample according to the ISCSCI is defined in Figures 6.1

and 6.2, with Figure 6.1 showing subgroups according to ISCSCI sensory levels and Figure 6.2

showing the distribution of the sample according to the ISCSCI motor levels (right and left data

are presented side by side). Approximately 52.5% of the individuals fall into the C6 - C7 motor

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levels while approximately 66% fall into the C4 - C6 sensory levels. The ISCSCI Impairment

Scale (AIS) which defines completeness of the sample identified 39% (n=28) of the sample as

AIS A complete and 61% (B-25% n=18; C-19% n=14; D-17% n=12) of the sample as AIS B, C

or D incomplete.

Figure 6: Histograms of Sample Distribution. 6.1 6.2

Figure 6.1 defines the sensory level distribution of the sample (n=72) as designated by ISCSCI and histogram 6.2 defines the motor level distribution of the sample as designated by ISCSCI. Both left and right are presented. Note: motor levels between C1 and C4 are based on sensory function.

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Reliability – Inter rater and test retest reliability were established for each subtest total,

right and left sides separately. Table 12 lists the non-parametric ICC values for the subtests

within the GRASSP, including the confidence interval for each value. ICC for inter rater

reliability ranged between 0.84 to 0.96 and test retest reliability ranged between 0.86 to 0.99 with

a significance level of p < 0.0001 for all values.

Table 12: Reliability Values of Subtest Scores within the GRASSP Subtest Inter rater Reliability Test Retest Reliability

ICC CI ICC CI SWM Right 0.84 0.75-0.89 0.95 0.91-0.97 SWM Left 0.91 0.86-0.94 0.86 0.76-0.92 Strength Right 0.95 0.93-0.97 0.98 0.98-0.99 Strength Left 0.95 0.92-0.97 0.98 0.96-0.98 Prehension Ability Right 0.95 0.92-0.97 0.98 0.96-0.99 Prehension Ability Left 0.95 0.92-0.97 0.98 0.97-0.99 Prehension Performance Right 0.95 0.92-0.97 0.93 0.88-0.96 Prehension Performance Left 0.96 0.93-0.97 0.96 0.93-0.98 Legend for Table 12: All values with significance level of p<0.0001

Construct validity is defined by the broader range of findings of impairment determined

by the sensibility and strength subtests within the GRASSP. Precision of the GRASSP was

established by comparing the sensibility and strength subtest items to the sensory and motor

upper limb items in the ISCSCI. It is known that the ISCSCI derives neurological levels based on

the complete intactness of normal innervations and in doing so, sensory and motor intactness

below the most normal level is not incorporated in defining the sensory and motor level.

Essentially, the impairment is not fully defined by the designation of a level in the ISCSCI. With

GRASSP, levels are not derived from the numeric values and as a result, in order to compare the

tests, items within each subtest were compared. It should be noted that individuals with a sensory

level of C5 or any level rostral to C5 would score 0 on the sensory testing in the GRASSP. The

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individual sensory (SWM) test locations and the individual muscles tested in the GRASSP were

compared to the sensory test locations for light touch and muscles for the upper limb in the

ISCSCI respectively. Referring back to the introduction for sensibility, the following two

additional components were added to the GRASSP: a greater number of response levels based on

the modality used and a greater number of test locations specific to the hand. ISCSCI sensory

and motor levels were used only to group the sample for presentation of the data; the items are

presented both in subgroups and as the whole sample. All comparisons were made for right and

left separately. Each study participants sensory information was compared (both dorsal and

palmar components from GRASSP were combined) and three conditions of comparison existed:

1) There was agreement between GRASSP sensibility and ISCSCI sensory items (absent,

impaired or normal) 2) There was discordance between GRASSP sensibility and ISCSCI sensory

items due to the added palmar test locations; and 3) There was discordance between GRASSP

sensibility and ISCSCI sensory items due to the increased response levels used in the GRASSP.

Table 13 defines the proportions of the subgroups and the whole sample that fall into these three

different conditions. On average 54% of the sample showed discordance in sensory innervation

when assessed with GRASSP due to the additional components of sensory testing included.

Table 14 shows the level of agreement between ISCSCI-Light Touch (ISCSCI-LT) and

GRASSP-SWM for the C6, C7, and C8 dorsal test locations. The kappa coefficients of C6, C7,

and C8 reveal that the level of agreement is not substantial; the statistical analysis indicates the

two tests demonstrate different results. Essentially ISCSCI-LT and SWM provide different

results regarding the sensory status of individuals with tetraplegia.

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Table 13: Construct Validity Agreement/Discordance of Sensory Results between GRASSP and ISCSCI (n=72)

AGREEMENT DISCORDANCE ISCSCI

Sensory Levela

N

N (%) 1

N (%) 2

N (%) Right Total Sample 72 32 (44) 16 (22) 24(33)

Left Total Sample 72 34 (47) 13 (18) 25 (35) Right C1 – C4 29 14 (19) 7 (10) 8 (11) Left C1 - C4 29 12 (17) 6 (8) 11 (15)

Right C5 11 5 (7) 4 (6) 2 (3) Left C5 9 5 (7) 3 (4) 1 (1)

Right C6 17 6 (8) 5 (7) 6 (8) Left C6 19 8 (11) 4 (6) 7 (10)

Right C7 8 4 (6) 0 (0) 4 (6) Left C7 6 3 (4) 0 (0) 3 (4)

Right C8 and below 7 3 (4) 0 (0) 4 (6) Left C8 and below 9 6 (8) 0 (0) 3 (4)

Legend of Table13: ISCSCI – International Standards for Neurological Classification of Spinal Cord Injury, Agreement – GRASSP and ISCSCI are consistent with assessment of sensation, Discordance 1 – due to added palmar test locations in GRASSP; Discordance 2 – due to the increased response levels (SWM) used in the GRASSP; aISCSCI levels are used only to subgroup the whole sample

Table 14: Level of Agreement between GRASSP-SWM and ISCSCI-LT for C6, C7 and C8 ISCSCI-LT GRASSP-

SWM C6 C7 C8

Right C6 Left C6

0.412 0.442

Right C7 Left C7

0.474 0.459

Right C8 Left C8

0.511 0.503

Legend of Table 14 presents the Kappa coefficients for the comparisons made between C6, C7 and C8 test locations on the dorsal surface of the hand. The comparisons are made between the LT and SWM measurements made over the same test locations. All values have a significance level of p < 0.001.

Each study participants strength information was compared and three conditions of

comparison existed: 1) There was agreement between GRASSP strength items and ISCSCI upper

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limb motor items; 2) There was discordance between GRASSP strength items and ISCSCI upper

limb motor items due to the added muscles in GRASSP; and 3) There was discordance between

GRASSP strength items and ISCSCI upper limb motor items due to the derivation of a level

from the motor testing in the ISCSCI. Table 15 defines the proportions of the subgroups and the

whole sample that fall into these three different conditions. On average 53% of the sample

showed a different degree of motor innervation when assessed with GRASSP due to the

additional muscles of the motor testing and the use of a summative numeric score to define

strength.

Table 15: Construct Validity Agreement/Discordance of Strength Results between GRASSP and ISCSCI (n=72)

AGREEMENT DISCORDANCE ISCSCI

Motor Levela

N

N (%) 1

N (%) 2

N (%) Right Total Sample 72 36 (50) 19 (26) 17(24)

Left Total Sample 72 34 (47) 20 (28) 17 (24) Right C1 - C4 10 1 (1) 6 (8) 3 (4) Left C1 – C4 14 6 (8) 6 (8) 1 (1)

Right C5 10 3 (4) 2 (3) 5 (7) Left C5 9 3 (4) 1 (1) 5 (7)

Right C6 23 13 (18) 3 (4) 7 (10) Left C6 21 11 (15) 5 (7) 4 (6)

Right C7 17 9 (12) 6 (8) 2 (3) Left C7 16 6 (8) 7 (10) 3 (4)

Right C8 4 2 (3) 2 (3) 0 (0) Left C8 5 1 (1) 1 (1) 3 (4)

Right T1 and below 8 8 (11) 0 (0) 0 (0) Left T1 and below 7 7(10) 0 (0) 0 (0)

Legend for Table 15: ISCSCI – International Standards for Neurological Classification of Spinal Cord Injury, Agreement – GRASSP and ISCSCI are consistent with assessment of strength, Discordance 1 – due to added muscles in GRASSP; Discordance 2 – due to deriving a level from numeric score; aISCSCI levels are used only to subgroup the whole sample

Concurrent Validity: Table 16 displays all of the concurrent validity values. Right and

left data were combined for this analysis and Pearson correlation coefficients were conducted to

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establish the association between GRASSP subtests and the CUE, SCIM and SCIM-SS. It was

noted that the total SCIM score shows the least association with subtests of the GRASSP,

however, the association is positive and is significant with a p-value of less than 0.0001. The

SCIM-SS shows a stronger association with the subtests of the GRASSP. This is similar to the

result reported by Rudhe and van Hedel (2009) showing the specificity of the self-care subscale

in SCIM to the upper limb motor testing done in the GRASSP. The CUE shows the strongest

associations with the GRASSP subtests which represent a strong association between self-

perceived function and impairment. As the secondary measures become more specific to the

upper limb, it is noted that the association becomes stronger for all domains. Subtests within the

GRASSP demonstrate moderate to substantial concurrent validity with the SCIM and the CUE.

This is indicative of a positive relationship between impairment, function and independence. It is

pertinent to note that the strongest associations linking impairment (GRASSP subtests) are those

between self perceived function (CUE), confirming that individuals perception of their own

ability is comparable to quantitative testing in the chronic SCI population.

Table 16: Concurrent Validity of GRASSP Subtests and Functional Measures Subtest Score SCIM SCIM-SS CUE

SWM Total (R + L) 0.57 0.74 0.77 Strength Total (R + L) 0.59 0.74 0.76 Prehension Performance Total (R + L) 0.68 0.79 0.83 Legend for Table 16: All values with significance level of p < 0.0001, Pearson Correlation Coefficient; Moderate Concurrence=0.61- 0.79, Substantial Concurrence=0.80-1.00; SWM - Semmes Weinstein Monofilaments, R - Right, L - Left

5.6 Discussion

In order for the GRASSP to be accepted as an adequate measure to define upper limb

sensorimotor deficit associated to cervical SCI, psychometric testing with the tetraplegic

population was a requirement. As a result of this study, the psychometric properties of reliability

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and validity have been established. The GRASSP was designed to be a sensitive clinical

impairment measure specific to the upper limb with a sound theoretical framework and relevant

domains.

Reliability is considered good for group level analysis when the ICC is greater than 0.75

(Streiner and Norman, 1995) and good for individual decision making at a level of 0.90

(Nunnally, 1996). Semmes Weinstein Monofilament testing (Mackin et al., 2003), motor testing

(Brandsma et al., 1995) and prehension skills (Sollerman and Ejeskar, 1995) have been shown to

be reliable with populations and components non specific to SCI. This study provides strong

evidence to support the reliability of the GRASSP when administered by trained clinicians

(ICC’s ranged between .84 - .98) and repeated assessments done by the same or different

assessor/s render reliable results. A change in the measurement of the GRASSP can confidently

be attributed to a clinical change in impairment of the upper limb; And the sample size required

for clinical trials using the GRASSP as an outcome measure would be reduced.

Validity - Two types of validity were established in this study. First, construct validity

was demonstrated by using the theoretical basis to develop a measure that was able to define a

broader range of findings (more sensitive), and in this particular case broader than the current

“gold standard”, ISCSCI. Greater accuracy was one of the underlying requirements set for the

GRASSP during the developmental phase as it was intentionally created to be a more accurate

representation of impairment in the case of sensation. This was to be accomplished by using a

more reliable sensory modality (SWM) with a greater range of response levels and by including

palmar test locations. To ensure a more accurate strength test, more than one muscle per

myotome was incorporated. Although the sample is small when grouped by ISCSCI level, the

specific muscles: anterior deltoid (C5), extensor digitorum, flexor policis longus (C8) and first

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dorsal interosseus (T1) provide important information regarding innervation. The greatest

amount of discordance was level specific (C5, C8 and T1) and predominantly due to the above

mentioned muscles. The added value of the additional elements to the sensibility and strength

testing showed that upper limb impairment was more accurately defined by the GRASSP than

previous approaches. ISCSCI sensory assessment fails to accurately represent the sensory status,

as sensation from only the dorsal side of the hand is assessed. In addition, the use of light touch

and pinprick as the test modalities in the ISCSCI is likely to affect the robustness of the construct

validity. Furthermore, the ISCSCI motor assessment inflates motor impairment (individual’s

appear more impaired than they really are), due to the method by which myotomal levels are

assigned.

Concurrent validity of a measure is determined by comparing a new test to related,

existing measures in the field. Since a specified upper limb measure of impairment for

tetraplegia did not exist, the best available functional measures were used. Concurrent validity is

determined when a new test shows the anticipated associations to the comparator measures used.

The subtests within the GRASSP show positive and significant associations with the functional

measures used in the field. The subtests which reflect impairment show moderate associations

with the SCIM and CUE, and the subtests which measure impairment within a functional

paradigm (prehension) show stronger associations with the SCIM and CUE. Finally, self

perception of function had the highest association with the GRASSP lending support to the

theory that patients can detect meaningfulness during reporting based on their perceptions.

The purpose of the GRASSP is to describe a profile of upper limb impairment after

tetraplegia. The GRASSP defines the impairment of the upper limb and how the sensory and

motor components affect hand function and is intended for use with the acute, post-acute and

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chronic tetraplegic individual. Repeated use over time should be able to provide a recovery

profile, whether due to spontaneous recovery, pharmacological interventions, or restorative

upper limb therapies. The GRASSP has been designed to capture changes in neurological

recovery rather than function alone although not all changes in neurological status are large

enough to be realized functionally. Furthermore, improved function, in some cases, may not be

associated with neurological recovery and functional measures in interventional studies are not

sensitive enough to detect small gains. Therefore, measuring impairment over the post injury

course is imperative to determine how much neurological recovery is actually occurring, and

how it relates to functionality.

We tested the GRASSP with a sample of individuals with chronic SCI in order to

diminish the effects of maturation when establishing reliability, thereby ensuring that the

individuals in the sample were considered stable as per the criteria of Wright and Feinstein,

(1992). The strength of the relationship between impairment and function may not be as strong in

more acute populations. Our ongoing longitudinal study is examining the temporal changes in

the three domains to determine their relationship to functional outcome of the upper limb.

We have shown the reliability of the GRASSP, demonstrating its use as a repeatable

measure. The strategies employed to reduce observer variability including the engagement of

experienced clinicians as examiners (occupational therapists/ physiotherapists) with SCI

experience, and the comprehensiveness of the training undoubtedly contributed to our findings.

Having relevant clinicians involved in assessment of neurological status improves consistency.

The results have provided the necessary evidence to confirm that the GRASSP has the

psychometric properties of reliability and validity and is ready for widespread use in cross

sectional studies. The global score will continue to be used as a composite of five subtest scores

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as there is importance in having a score or set of scores that distinguish change among the

different domains tested by the GRASSP. Sensation and strength scores can be utilized to define

deficit of the upper limb as it relates to spinal cord function and the prehension scores can be

utilized to determine how the components (sensation and strength) impact function. The

individual domains are important to upper limb function individually, therefore, presenting five

subtest total scores on a cluster bar graph will remain the process of presentation of the GRASSP

scores.

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CHAPTER VI: RESULTS PART 3

6.1 RELATIONSHIPS OF SENSORY AND MOTOR IMPAIRMENT TO

PREHENSION AND UPPER LIMB FUNCTION

6.2 Abstract

It is understood that the degree of impairment is negatively associated to declined

function such that as impairment decreases functional ability improves. The proportion of

change in function that is attributed to sensation and strength has not been well defined for

the upper limb after tetraplegia. While the association of strength to function is well

established in SCI, the association of sensation to function is not. As a result, the role of

sensation and the need to assess it has received less attention in the field. Objectives: 1) to

examine the relationship of impairment (sensibility, strength, and prehension) domains

within the GRASSP to upper limb function. Methods: A cross sectional study was

conducted; all participants had varying degrees of tetraplegia and were neurologically stable,

(n=72). The study protocol included administration of the GRASSP, ISCSCI, CUE and

SCIM during the same session. Hypothetical models which represented the relationships of

impairment and function were tested with both analyses. Analysis: Multiple linear regression

analysis and structural equation modeling were conducted to estimate the effect of the

impairment domains on upper limb function. Results: Multiple linear regression confirmed a

strong association between sensation and strength to prehenssion, but not a strong association

of strength to upper limb function. Structural equation modeling confirmed the association

of sensation, strength and prehension were strong with upper limb function. Structural

equation modeling showed a perfect fit with the data and the goodness of fit indices were

well above the accepted thresholds in [square brackets] (Chi-square = 14.3, p = 0.11,

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[insignificant p-value]; Comparative Fix Index = 0.99, [above 0.96]; Tucker-Lewis Index

=0.97, [above 0.96]; Root Mean Square Error of Approximation = 0.09, [less than 0.10];

Standardized Root Mean Square = 0.02, [less than 0.09]). The model explained 72% of the

variance in “sensorimotor upper limb function”. Conclusions: The results indicated both

sensation and strength influenced upper limb function directly and indirectly and supported

the hypothesis that prehension was the mediator of sensation and strength for upper limb

function. Strength and sensation played significant roles in ability to perform prehension

tasks which subsequently had a strong association to upper limb function. The results are

significant because the effect of sensation and strength on prehension and upper limb

function provide substantive evidence that supports: 1) therapeutics to be targeted not only

towards strengthening of musculature of the upper limb and also towards promoting sensory

recovery of the palmar surface of the hand, 2) therapy to be applied within a meaningful

functional context, and 3) focus on interventions that target the components of upper limb

function that require the integration of sensory and motor function.

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6.3 Introduction

Upper limb function is integral to global function and independence for individuals

who suffer from traumatic tetraplegia, therefore, restoration of upper limb function is of great

significance to this population (Anderson, 2004). The more normal and exquisite the upper

limb function becomes after tetraplegia, the more functional and independent an individual

can become. Assessment and restoration of upper limb function for individuals with

tetraplegia entails a multi faceted approach. To date, the impact that an improvement in

impairment has had on function has been defined as positive (Dahlberg et al., 2003; Tooth et

al., 2003; Curt and Dietz, 1996; Schonherr et al., 1999; Mizukami et al., 1995), however, the

amount of change in impairment that influences a specific or meaningful change in function

remains undefined. Furthermore, the type and nature of changed impairment that influences

function also remains undefined. Ultimately, the relationship between impairment status and

functional status is not well established or understood (Ota et al., 1996; Sinnott et al., 2004)

and a stronger understanding of impairment and its role in upper limb function could provide

valuable information to support clinical decision making. This is turn would enhance

recovery through the application of targeted therapeutic interventions (Kirshblum and

O’Connor, 2000).

Exploring the role of specific impairment domains (sensation, strength and

prehension) which contribute to “upper limb function” (reach, prehension, and manipulation)

was the concept of interest. It was conceptualized in the theoretical framework (Figure 1,

Chapter 1) that all three domains did play a role in upper limb function but the contribution

of each component was unknown and where the intermediate relationship (integration)

existed among impairment domains was not fully understood. We did hypothesize within the

framework that sensation and strength are integrated and the mediator was prehension. There

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is limited literature that discusses these relationships specific to tetraplegia; motor strength

and its relationship to global function is often documented (Fisher et al., 2005) while, the

sensory relationships specific to global function and upper limb function remain under

reported. The specialized field of tendon transfer in tetraplegia reports the significance of

intact sensation (measured by two point discrimination) pre-operatively and its positive

impact on outcomes post-operatively (Moberg, 1976; Sollerman and Ejeskar, 1995).

Furthermore, some preliminary evidence from the Field-Fote laboratory, at the Miami

Project, Cure for Paralysis has reported improvements in sensation, measured by Semmes

Weinstein Monofilaments after a three week intensive massed practice and somatosensory

stimulation protocol. They also found that overall hand function was most improved for

individuals receiving massed practice and somatosensory stimulation, versus just massed

practice or somatosensory stimulation, or conservative management alone (Beekhuizen and

Field-Fote, 2005; Hoffman and Field-Fote, 2007; Beekhuizen and Field-Fote, 2008).

The relationship between the recovery of sensation of the hand is considered to be

activity-dependent (Lundborg, 2000); alterations in hand activity and tactile experience play

a role in the recovery of hand function. The feedback system between the hand and the brain,

otherwise known as sensation operates with continuous proprioceptive and tactile input,

which is coordinated with the feed forward systems in the brain. These two systems are

prerequisites for the regulation of grip force, grasp, and grip speed (Johansson, 2002;

Lundborg and Rosen, 2007). These concepts are well defined within the peripheral hand

injury literature; however, have yet to be established for individuals with tetraplegia. Thus,

based on the significance of sensation to the recovery of hand function in other populations,

sensation was included as a separate domain within the construct of the GRASSP. There is

some evidence to support intact sensation precedes motor recovery (Poynton et al., 1997)

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specific to SCI, which can be related to post injury cortical and tract plasticity. Ultimately,

establishing the significance of sensation and its role in recovery in tetraplegia is not as

advanced as in other upper limb and hand research fields such as: stroke and peripheral hand

injury.

One reason why impairment had not been clearly connected to function for the

tetraplegic population was because specific tests which quantify impairment with sensitivity

had not been used in the SCI population, particularly sensory tests. Furthermore, the methods

used to analyze the relationships between impairment and function have not been

sophisticated enough to define the factors which clinicians would know to be significant and

sometimes mediators. The GRASSP (Kalsi-Ryan et al., 2009) was developed to incorporate

three domains which, in detail, assess sensation, strength and prehension of the upper limb

for individuals with tetraplegia. The impairment data from the GRASSP has provided an

approach to examine sensorimotor components and their relationship to upper limb function.

Ultimately, the objective of this analysis was to determine the association between

impairment domains (sensation, motor and prehension) and the concept of “sensorimotor

upper limb function” for individuals with chronic tetraplegia. Table 17 provides the scores of

each subtest in the GRASSP for reference.

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Table 17: GRASSP Scoring Details (Subtest and Item Scores and Ranges) Subtest Item Score

Number of Items

Subtest Total Score

Range

Intended Meaning of Score

Dorsal Sensation 0-4 3 0 - 12 0-4 – C6 5-8 – C7 9-12 – C8

Palmar Sensation 0-4 3 0 - 12 0-4 – C6 5-8 – C7 9-12 – C8

Strength 0-5 10 0 - 50 0-10 – C5 11-15 – C6 16-25 – C7 26-40 – C8 41-50 – T1

Prehension Ability 0-4 3 0 - 12 0-6 – C5-C6 7-12 – C7-T1

Prehension Performance

0-5 6 0 - 30 0-5 – C5-C7 6-10 – C5-C7 11- 15 – C5-C7 16-20 – C5-T1 21-25 – C5-T1 26-30 – C5-T1

6.4 Methods

Ethical approval was attained at all institutions participating in the study and the

analysis was conducted on a dataset collected to develop and establish the psychometric

properties of the GRASSP. A sample size of 40 people was calculated based on an estimated

ICC of 0.80 or greater with an alpha of 0.05. The minimum estimated sample size was 39 for

3 repeated measures according to Donner & Eliasiw’s estimation curves (Donner and

Eliasiw, 1987). Design: A cross sectional, multi centre trial was conducted to collect

impairment and functional data on a sample of n = 72. Seven centres participated in the trial

(three European and four North American). Inclusion/Exclusion: Individuals with chronic

traumatic tetraplegia who were neurologically and medically stable, between the ages of 16

and 65 and able to provide informed consent were included in the study. Individuals with

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moderate brain injury who were neurologically unstable, and those with any other pathology

causing upper limb impairment were excluded from the study. As a result of the multi centre

collaboration a greater number of datasets were available, allowing the n value to increase to

72. Data collection and management: Two workshops (one in Europe and one in North

America) were conducted to train the examiners regarding the study protocol and appropriate

use of all study measures. Instruction and demonstration in the administration of the primary

measure, GRASSP and secondary measures were provided. The ISCSCI (Marino, 2000), The

SCIM (Catz et al., 2004), and CUE (Marino et al., 1998) were provided to all examiners

involved in the study. All data were collected by the examiners, de-identified and entered

into excel tables; once entered all data was transferred to the central site for pooling. Data

from all centres were aggregated, cleaned and analyzed using SPSS 17.0 and M-Plus 5.2.

The GRASSP is a multi domain impairment measure specific to the upper limb for

individuals with tetraplegia; details of the development and content are available in a

previous manuscript (Kalsi-Ryan et al., 2009) The ISCSCI is a classification measure which

describes the severity of injury for individuals with SCI; this measure was used to describe

the sample in the results. The SCIM is a global measure of function specific for individuals

with SCI, used to define the global function and independence of the sample in this study.

Inter rater reliability is above 0.8 when assessed by agreement statistics for most SCIM

items, and ICC for the total score is 0.94. Concurrent validity of the SCIM with the FIM is

0.79 (Itzkovich et al., 2007). Within the SCIM, there are three subscales (self care,

respiration and sphincter management, and mobility) and in this analysis the SCIM self care

subscale (SCIM-SS) was used as one of the representations of upper limb function. The

SCIM-SS includes items solely related to the use of the upper limb; therefore, comparisons

between the GRASSP subtests are made with the SCIM-SS, rather than the total SCIM score.

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Subscales of the SCIM are reliable and useful quantitative representations of the specific

constructs of independence in SCI (Catz et al., 2007). Some researchers have found the

subscales to be more specific for targeted analyses (Rudhe and van Hedel, 2009; van Hedel,

2009).

The CUE is a subjective questionnaire that determines ones own perception of

functional ability. The questions asked are related to one’s perception of how difficult a task

may be. The CUE is embedded with questions that fall into the three components of upper

limb function reaching tasks, prehension tasks, and manipulation tasks, scores for each task

are added for a total CUE score. Psychometric properties of the CUE have been reported as

0.92 for test retest reliability, tested by Cronbach’s alpha and 0.74 for concurrent validity

with the Functional Independence Measure, tested by Pearson correlation coefficient (Marino

et al., 1998). GRASSP, SCIM and CUE results collected during the same visit were extracted

from the dataset for the analysis of impairment and “upper limb function”. All measures used

in the study are available in Appendices 1 and 3.

Analytic Plan: A priori we anticipated there would be a positive relationship between

the impairment domains and upper limb function; specifically, strength would play a stronger

role than sensation in upper limb function. However, the strength of the relationship was

unknown. We anticipated that there was an intermediate relationship where strength and

sensation would influence prehension and as such, prehension would then have an

association with upper limb function. Based on the intermediate role that prehension plays in

the construct of “sensorimotor upper limb function” it was anticipated the core and integrated

elements of impairment would have unique roles in “sensorimotor upper limb function”.

Two methods of analysis were used to explore the relationships between impairment

and function: Multiple linear regression and structural equation modeling. Three

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hypothesized models were designed for multiple linear regression. The relationship between

several independent variables and a single dependent variable were examined, however, due

to the fact that only one dependent variable per model could be explored, three models were

tested and the collective results were used to define the relationships between impairment

and function. Selection of the independent and dependent variables was based on the

theoretical framework both the domains construct. The independent variables used in the

multiple linear regression were the palmar sensation subtest total score, the strength subtest

total score, and prehension performance subtest total score, right side data only (see Table

17). The SCIM-SS was used as a representation of upper limb function and the CUE was

used as a representation of self perceived upper limb function. In model A the palmar

sensation subtest total and strength subtest total scores were used as the independent

variables with the prehension performance subtest total score as the dependent variable. In

models B and C the palmar sensation subtest total, strength subtest total and prehension

performance subtest total scores were used as the independent variables with the SCIM-SS

and CUE respectively, as the dependent variables. Multiple linear regression was conducted

to determine the role of the impairment variables and their influence on upper limb function.

The second analysis approach examined the relationship between the same variables

and structural equation modeling was used. Structural equation modeling is a general

approach to multivariate data analysis, used to study complex relationships among variables.

Structural equation modeling has become an important data analysis technique, and can be

used as a language to formulate social science theories; and can define the relationships and

pathways between variables. Structural equation modeling is used to describe directed

dependencies among a set of variables and provides an opportunity to test models with

multiple dependent variables and provides a value of both direct and indirect effects of all

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variables. Some of the variables can be hypothetical or “unobserved”. The “unobserved”

variable is called the latent trait variable. In this case the latent trait was sensorimotor upper

limb function. The SCIM-SS and CUE were the indicators of the latent trait. Essentially

structural equation modeling is a confirmatory technique which confirms a specified model

(the hypothesis). The results define redundancies and pinpoint aspects of conflict with the

data (Wothke, 2010). The fit of the model is confirmed by the analysis, which is known as

the “goodness of fit” (Hooper et al., 2008). Statistics of fit determine how well the specified

model (hypothesis) fits the actual data. A chi-square test is conducted to evaluate the overall

model fit, which assesses the magnitude of discrepancy between the sample and fitted

covariance matrices. A large chi-square with an insignificant value when compared to p<0.05

is indicative of a good fit of the model. The chi-square, although not the most rigorous index

of fit is used and often accompanied by other indices. The root mean square error of

approximation (RMSEA) evaluates how well the model fits the population’s covariance and

is sensitive to the number of estimated parameters in the model. A value less than 0.10 is

indicative of a fair fit (Black, 1993). The RMSEA is used when the number of estimated

parameters is low in the case of this model, only one parameter is estimated. The

standardized root mean square residual (SRMR) is the square root of the difference between

the residuals of the sample covariance matrix and the hypothesized covariance model. A

value of less than 0.09 is indicative of a good fit. The SRMR is used when there are varying

ranges of scales among indicators, which is the case in the model tested. The comparative fit

index (CFI) accounts for the sample size, all latent variables are uncorrelated and compared

to the sample covariance matrix with the null model and the Tucker-Lewis Index (TLI) of fit

is used when a small sample size is being analyzed and can point out a poor fit when other

indices are pointing to a good fit. A value above 0.96 indicates a good fit for both of these

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indices. The CFI considers the small sample size and the TLI considers simple models. Thus,

the selection of indices was specific to the model hypothesized (Hooper et al., 2008). All

hypotheses were examined simultaneously by specifying one structural equation model

labeled Model D (Figure 7). In this analysis, we incorporated one latent variable of

“sensorimotor upper limb function”, which brought several benefits to the measurement of

variables in this model, hence the accuracy of its structural relations (Tomarken and Waller,

2005).

Figure 7 defines the hypothetical model for which structural equation modeling was

conducted to determine the relationship of impairment to upper limb function. In structural

equation modeling it is necessary to establish a latent trait variable otherwise known as an

unobserved value which is indicated or estimated by observed variables. In the case of our

model, we established our latent trait variable to be “upper limb function”. “Upper limb

function” was indicated by the SCIM-SS and the CUE component (reach, prehension,

manipulation) scores. In structural equation modeling it is more reliable to have at least three

variables estimate the latent trait (Sudano, 2010); therefore, the CUE was split into the three

components (reach, prehension, manipulation) that represent upper limb function (Shumway-

Cook and Woollacott, 2007; Kapandji, 1970).

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Figure 7: Model D, Hypothetical Model of Impairment and Sensorimotor Upper Limb Function in Tetraplegia to be tested with Structural Equation Modeling.

Legend for Figure 7: Palmar sensation is represented by the palmar sensation subtest score, strength is represented by the strength subtest score, and prehension is represented by the prehension performance subtest score within the GRASSP. SCIM-SS is the self care subscale total, CUE-reach, the responses for reaching tasks totaled, CUE-prehension, the responses for grasp tasks totaled and CUE-manipulation, the responses for manipulation tasks totaled within the CUE. The latent trait variable is sensorimotor upper limb function. This model represents the hypothesized association of palmar sensation, strength and prehension, and the relationship of the three impairment domains to sensorimotor upper limb function in the same model. The strength of associations is not pre-determined.

6.5 Results

Sample - The data used in this analysis included a multi centre/multi national cross

sectional sample. The total sample consisted of 72 individuals with chronic tetraplegia

ranging from 6 months to 20 years post injury. Distribution of the sample according to the

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ISCSCI is defined in Table 18. Approximately 52.5% of the individuals fall between the C6 -

C7 motor levels while approximately 66% fall between the C4 - C6 sensory levels. The AIS

which defined completeness, classified 39% (n=28) of the sample to be AIS A complete, and

61% (B-25% n=18; C-19% n=14; D-17% n=12) of the sample as AIS B, C or D incomplete.

Table 18: Demographics of the Sample Based on ISCSCI and AIS Classification, n=72 (presented as n values and percentages of sample)

ISCSCI Levels Motor Level

n (%)

Sensory Level

n (%)

AIS Classification

n (%) Right Left Right Left A B C D

C2-C4 10 (14) 14 (19) 29 (40) 29 (40) C5 10 (14) 9 (13) 11 (15) 9 (13) C6 23 (32) 21 (29) 17 (24) 19 (26) C7 17 (24) 16 (22) 8 (11) 6 (8) C8 4 (5) 5 (7) 1 (2) 2 (3)

T1 and below 8 (11) 7 (10) 6 (8) 7 (10)

28 (39)

18 (25)

12 (17)

14 (19)

Legend for Table 18: ISCSCI – International Standards for Neurological Classification of Spinal Cord Injury, AIS – ASIA Impairment Scale

Prior to conducting both analyses all variables were correlated with one another.

Table 19 presents the Pearson correlation coefficients between the measures of upper limb

function and the variables for the impairment domains. The values in table 18 reveal that

sensory, strength and prehension are significantly and positively associated with each other,

and they are all correlated with the measures of upper limb function.

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Table 19: Correlation Matrix of all Variables Included in the Multiple Linear Regression and Structural Equation Modeling Sensory Strength Prehension SCIM CUE

Total CUE Reach

CUE Prehension

CUE Manip

Sensory 1 - - - - - - - Strength 0.685 1 - - - - - - Prehension 0.656 0.811 1 - - - - - SCIM 0.636 0.692 0.689 1 - - - - CUE Total 0.693 0.705 0.730 0.855 1 - - - CUE Reach 0.578 0.518 0.597 0.785 0.924 1 - - CUE Prehension

0.653 0.731 0.708 0.754 0.922 0.753 1 -

CUE Manipulation

0.692 0.771 0.731 0.769 0.858 0.617 0.839 1

Legend for Table 19: All correlation values are Pearson correlation coefficients with p<0.0001. Sensory represents the palmar sensation subtest score, strength represents the strength subtest score, and prehension represents the prehension performance subtest score within the GRASSP. CUE-reach, the responses for reaching tasks totaled, CUE-prehension, the responses for grasp tasks totaled and CUE-manipulation, the responses for manipulation tasks totaled within the CUE. The CUE Total is the total CUE score.

Multiple linear regression analysis rendered the strength of association between the palmar

sensation, strength and prehension variables to upper limb function. Figure 8 presents the

models and the relationships between the independent and dependent variables; each model

presents different variables to explore the multiple associations. The standardized coefficient

was used to report the strength of association and the significance level is denoted by the

asterix. The SCIM-SS is representative of upper limb function and the CUE is representative

of self perceived upper limb function Table 20 presents the unadjusted values derived from

the multiple linear regression analyses, these values differ from the standardized coefficients

which were used to determine the linear relationships between the independent and

dependent variables.

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Table 20: Unadjusted Multiple Linear Regression Values for Palmar Sensation, Strength and Prehension when Compared to SCIM-SS and CUE values Prehension SCIM-SS CUE Palmar Sensation 0.499 0.393 2.661 Strength 0.505 0.122 0.420 Prehension - 0.179 1.119 Legend for table 20: Palmar sensation represents the palmar sensation subtest score, strength represents the strength subtest score, and prehension represents the prehension performance subtest score within the GRASSP. SCIM-SS – represents the Spinal Cord Independence Measure selfcare subscale and CUE – represents the Capabilities of the Upper Extremity Questionnaire total score.

Figure 8 presents the results of the multiple linear regression analysis. Model A

defines palmar sensation and strength to have strong and significant associations to

prehension, therefore, palmar sensation and strength of the upper limb play a significant role

in mediating prehension. Model B defines palmar sensation and prehension as having strong

and significant associations, and motor as having no direct association to upper limb function

as represented by the SCIM-SS. Model C defines palmar sensation and prehension as having

strong and significant associations, and motor as having no direct association to upper limb

function as represented by the CUE.

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Figure 8: Results of Multiple Linear Regression of Impairment Variables and Upper Limb Function.

Legend for Figure 8: Palmar sensation represents the palmar sensation subtest score, strength represents the strength subtest score, and prehension represents the prehension performance subtest score. SCIM-SS is the self care subtest score in the SCIM and the CUE is the total score for the questionnaire. Model A represents the model tested to determine the association of palmar sensation and strength impairment to prehension. Model B represents the model tested to determine the association of palmar sensation, strength and prehension to the SCIM-SS. Model C represents the model tested to determine the association of palmar sensation, strength and prehension to the CUE.

Multiple linear regression was used to determine the relationships of the domains as

they were defined in the theoretical framework through the three hypothesized models in

Figure 8. Multiple linear regression was not conducted as a stepwise process where variables

are eliminated when they are insignificant in a model. Collectively, the three models

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combined showed that palmar sensation and strength contributed significantly to prehension.

However, only palmar sensation and prehension contributed significantly to upper limb

function as defined by the SCIM-SS and CUE. The role of strength was not confirmed as a

significant contributer upper limb function.

Structural equation modeling rendered the strength of association between

impairment, function and the latent trait variable of sensorimotor upper limb function. Figure

9 presents the structural equation modeling results for model D which defined the effect of

impairment on sensorimotor upper limb function. The structural equation modeling showed a

perfect fit with the data and the goodness of fit indices were well above the accepted

thresholds. Chi-square = 14.3, p = 0.11; Comparative Fix Index = 0.99, Tucker-Lewis Index

= 0.97 and the Root Mean Square Error of Approximation = 0.09, Standardized Root Mean

Square SRMR = 0.02. The model explained 72% of the variance in “sensorimotor upper limb

function”. Prehension has a significant positive effect on upper limb function and strength

and palmar sensation both have a direct and indirect effect through prehension on upper limb

function.

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Figure 9: Model D, Structural Equation Model for Impairment and Sensorimotor Upper Limb Function after Tetraplegia.

Based on the structural equation modeling, palmar sensation showed a direct and

indirect relationship to upper limb function. The relationship mediated through prehension is

larger (.19+.32) than the direct relationship (.31); but both direct and indirect relationships

are statistically significant. The relationship mediated through prehension is larger (.68+.31)

than the direct relationship to upper limb function, but both direct and indirect relationships

are statistically significant. Therefore, sensorimotor upper limb function can be predicted by

palmar sensation and strength through prehension. As structural equation modeling clarified

the relationship of strength with respect to upper limb function, structural equation modeling

is the preferred model to confirm the hypothetical model (Figure 7). The structural equation

modeling accounted for all variables in one model which demonstrated that strength is

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related to upper limb function and why in contrast strength was not a significant factor in

upper limb function with multiple linear regression.

6.6 Discussion

It was hypothesized that sensation and strength are mediated through prehension

when affecting function, which was a feature of the theoretical framework for GRASSP

development. The data confirmed this hypothesis. A priori we assumed it was important to

measure all domains of impairment to reflect function accurately. There is little evidence

available to define the inter-relationship between sensation and strength on upper limb

function in tetraplegia. As interventions are more likely to target neurological substrates to

enhance recovery, the most common outcome that should be assessed to determine efficacy

is degree of impairment. Impairment change and how impairment impacts function and

independence is one factor that is used to determine whether an intervention demonstrates

efficacy. To date there is not a strong understanding of how degree of sensory and motor

impairment influence function. Although, some researchers have recognized that poor

functional gains after tendon transfer for increased movement are likely to be related to poor

sensory function (Sollerman and Ejeskar, 1995; McDowell et al., 1986).

The present research provides the evidence to verify that there is a relationship

between sensorimotor impairment and function of the upper limb for individuals with chronic

tetraplegia. It should now be possible to determine if a positive change in sensation results in

improved upper limb function. The way in which sensation and strength are integrated

through prehension and how they directly impact upper limb function is supported by

confirming Model D. The relationships of sensation and strength mediated through

prehension show that strength is a stronger factor. These strong relationships of upper limb

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function mediated through prehension support the concept of rehabilitation processes

incorporating the use of functional tasks specifically prehension retraining protocols. Using

the structural equation modeling approach across the recovery period could assist in

determining the magnitude of impairment change that will lead to different levels of

functional change.

Sensation is reported to have a significant impact on hand function (Shumway-Cook,

2007; Brand and Hollister, 1991). Recovery of sensation after peripheral hand injury is very

important for the return of function (Moberg 1986; Lundborg and Rosen, 2007). And there is

some evidence to suggest that improvement in sensation during recovery is mediated at the

cortical and tract level (Beekhuizen and Field-Fote, 2008 and Green et al., 1999). The

relationship of hand sensation to upper limb function has not been well established for

individuals with tetraplegia. Structural equation modeling substantiates that sensation is

important, as a component to both prehension and upper limb function. As there is a

significant relationship between sensation and prehension (.19 p<0.05) and then a significant

relationship between prehension and upper limb function (.32 p<001), the role of palmar

sensation is definitive. Therefore, it is of great importance that recovery of sensation be

enhanced after SCI. Targeted sensory retraining of the hand within a functional paradigm

(task specifically-prehension) may be necessary to refine functional ability during the

rehabilitation phase. In this analysis it is noted that having good sensation indirectly impacts

upper limb function, not only prehensile and manipulation tasks. Albeit not specific to the

upper limb, Poynton in 1997 demonstrated that patients with sensory sparing in dermatomes

regain at least a grade 3 in strength for the associated myotome over time, suggesting that the

mere presence of sensation enhances sensorimotor recovery.

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The recovery of upper limb strength after tetraplegia has been reported to be very

important for the restoration of function (Fisher et al., 2005; Taylor et al., 2002; Rothwell et

al., 2003). The impact that strength has on function in tetraplegia is so well established; that

other factors such as sensation are not always considered to have the same importance in

recovery of function. Strength plays the dominant role in prehension and this is probably true

for many other motor tasks because intact sensation without strength is not functional. The

meaning of the analysis supports the theory that if strength is available it should be within a

functional paradigm to be optimal.

The research findings provide strong evidence to support two aspects of therapeutic

approaches for individuals with tetraplegia. First, interventions should target both the motor

and sensory aspects of recovery. Therapies need to be applied so that the palmar surface of

the hand is stimulated, to promote activity optimizing sensory activity leading to recovery.

The most ideal interventions would provide sensory stimulation while the hand engages in

functional tasks; this method would target the mechanisms that in theory influence cortical

plasticity and reorganization. Secondly, interventions targeted towards recovering motor

function must be in a functional context, with varying degrees of force generation and

sequencing of muscle activation. Reaching transports the hand to the location of the task. The

reach enables the prehension which is modulated by the sensation and strength of the hand.

Once prehension has been engaged, sensibility of the hand and strength of the small muscles

in the hand enable manipulation. Therefore, therapy interventions should incorporate task

oriented protocols which engage the entire upper limb and incorporate sensorimotor

functions.

The GRASSP assesses impairment with acuity in three domains. During the

development of the GRASSP the theoretical framework guided item generation to be

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anatomically, neurophysiologically and functionally relevant. Sensorimotor upper limb

function has been tested in this research using data from a sample with chronic SCI. The

structural equation modeling confirms the concepts and components of the construct

particularly the domains and their individual and integrative importance.

The robust findings in model D from this analysis were possible because the data

comprehensively represented the impairment of the upper limb in tetraplegia. Quantifying

impairment more precisely has enabled the investigators to establish the strength of the

relationships and integration of palmar sensation, upper limb strength and prehension to

upper limb function. The next steps will be to test the degree of these relationships and

integration during the course of recovery.

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CHAPTER VII: GENERAL DISCUSSION

7.1 Summary of Findings

Upper limb impairment after tetraplegia was defined as the “phenomenon of interest”

that we intended to measure; subsequently, becoming the purpose of the GRASSP. The

theoretical framework was developed which incorporated the functional, anatomical and

neurophysiological mechanisms of normal upper limb function; and the pathophysiology of

SCI. The framework incorporated concepts and theories of sensorimotor control/

sensorimotor learning (Kandel et al., 2000), and the interactions between the

cognitive/sensory/motor systems that play significant roles in normal upper limb function

(Shumway-Cook and Woollacott, 2007). The core elements of impairment (sensation and

strength) and the integrated element of impairment (prehension) were included as domains of

the construct. The three components of upper limb function (reach, prehension and

manipulation) were represented within the items of the domains of the construct. Therefore,

the information rendered by the GRASSP represents the sensation, strength and prehension at

the periphery. However, how these domains relate to the concepts which define the construct

“sensorimotor upper limb function” and allow us to develop knowledge in how best to

influence the concepts, theories and components that define upper limb function.

The overall objective of this thesis was to complete the development of the GRASSP.

Development of the GRASSP has been a staged process and the findings in this thesis have

finalized the measurement properties and the concepts important for practical use of the

measure. Data was collected over an eight month period with a protocol designed for the

study of reliability and validity. The dataset provided a number of data elements which were

used for multiple analyses. The initial analysis which was not included in this thesis

evaluated the items in the initial GRASSP to finalize inclusion and exclusion of the items in

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GRASSP Version 1.0 (Appendix 1). The following sections will comment on my

accomplishments of the specific objectives listed in Chapter 2.

7.1.1 Objective One: Development of the Scoring System

The first set of analyses reported in this thesis, indicated how the scoring system was

determined for reporting output from the GRASSP. It was established that assigning a spinal

cord level to numeric values would diminish the true meaning of scores. Therefore, it was

first determined that the items showed a predominant cumulative predictive pattern, thus, the

subtest items could be summed and used as subtest total scores to define impairment of the

upper limb. Theoretical basis of the GRASSP and spinal cord anatomy provided the

definitions for the levels of GRASSP scores. The ISCSCI and AIS did not discriminate the

sample similarly to the GRASSP. The GRASSP discriminative score ranges were not

concordant with the ISCSCI due to the differences in how impairment is defined by both

measures. The GRASSP defines the impairment as a numeric value which incorporates any

amount of neurological intactness between levels, whereas, the ISCSCI defines the

impairment based on the most caudal “normal” spinal cord level. For the purpose of

quantifying impairment; a numeric value which represents all of the impairment is an optimal

method to define upper limb impairment. Essentially, numeric values derived at the periphery

which represent the spinal cord spatially show greater precision in defining impairment.

Based on the subtest scores being meaningful as totals, a method to define all scores in one

place was derived. Because scores could not be added for one global score as there is no

internal consistency among domains, normalizing the subtest total scores and plotting the

values on a bar graph was the method derived to present GRASSP output. Summary of

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objective one; the scoring system of the GRASSP has been developed to render numeric

values which are meaningful, robust and interpretable.

7.1.2 Objective Two: Psychometric Testing

Psychometric properties were then established to ensure that GRASSP subtest scores

were reliable and valid. Reliability of a measure ensures that the change noted between

assessments can be attributed to a clinical change rather than error in measurement. As

hypothesized inter rater and test retest reliability for all subtests within the GRASSP were

above an ICC of 0.80 (0.83-0.96 and 0.86-0.99 respectively). Therefore, confirming that the

GRASSP can be administered as a repeated measure by the same or multiple examiners to

determine change in a clinical setting or in a clinical trial. This level of reliability would

provide values for a smaller sample size calculation, which is beneficial in SCI research

where incidence and prevalence is low and large samples are difficult to recruit. Construct

validity was confirmed by discordance of the sensibility and strength subtests within the

GRASSP to the ISCSCI sensory and motor items; the subtests showed concurrence with the

SCIM, SCIM-SS and the CUE. Impairment domains had the strongest concurrence with self

perception of function (0.57 - 0.83, p < 0.0001). Summary of objective two; the GRASSP has

demonstrated reliability, construct and concurrent validity for use as a standardized upper

limb impairment measure for individuals with tetraplegia.

7.1.3 Objective Three: Confirmation of Theoretical Framework

With the availability of detailed impairment data regarding the upper limb, some

principles of sensorimotor relationships to upper limb function specific to tetraplegia were

defined. It was determined that sensation and strength played a dual role in mediating upper

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limb function, one which was mediated through prehension and one which directly affected

upper limb function. It was also determined that in the model of measurement, prehension

was one point where sensation and strength converge, to play an integrative role in upper

limb function. The statistical methodology provided the opportunity to establish the

integrative relationships among impairment and function which substantiate current theories

of neuro-rehabilitation. Summary of objective three; sensation and strength and subsequently

prehension all play unique and indirect and direct roles in upper limb function.

Development begun with a theoretical framework which guided the process of

GRASSP development. In summary a novel impairment measure for the upper limb has been

developed. The data captured by the GRASSP provides relevant information in the form of

numeric values. The output is representative of the degree of intactness at the periphery and

spinal cord. The GRASSP is both reliable and valid, therefore, provides meaningful

impairment data that can be used to follow individuals over time, which measures what it is

intended to measure with a broader range of items with greater response levels. Therefore,

the GRASSP is a measure which can be used clinically and in clinical trials as an outcome.

The impairment data that is rendered by the GRASSP is accurate, precise and describes

impairment under a finer lens, enough to establish relationships between function and

impairment. These relationships between impairment and function are meaningful, during

recovery and for the evaluation of the application of new interventions.

7.2 Impact, Significance and Strengths of the Research

The lack of a precise impairment measure specific for the upper limb after tetraplegia

has made it challenging for researchers to quantify the neurological change of the upper limb

and then relate the change to functional gains. The GRASSP measures upper limb

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impairment for individuals with tetraplegia during the acute to chronic phases of recovery.

The findings of the measure can be used to make the connection between natural recovery

and interventions and their potential influence on impairment. The GRASSP is a clinical

measure and it can easily be incorporated into multiple clinical practice settings. The most

significant outcome of my PhD work has been the production of the GRASSP Version 1.0.

Table 21 summarizes the attributes of the measure. The contribution of the GRASSP Version

1.0 to the field of SCI research will have a significant impact on the next generation of

clinical trials which include participants with tetraplegia, and studies related to developing

methods to restore upper limb function. The GRASSP will provide an opportunity for

researchers to assess the more subtle changes that occur as a result of interventions and

natural recovery. The GRASSP can be administered earlier in the course of recovery than

most current outcomes measures.

Table 21: Attributes of the GRASSP Version 1.0 Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) Purpose of the Measure Designed to measure impairment of the upper limb after

tetraplegia Theoretical Framework Defines the underlying anatomical and neurophysiological

concepts and theories which play a role in upper limb function. Explains why the construct for the measure is “sensorimotor upper limb function”. Defines core and integrated elements of impairment which contribute to upper limb function.

Description of Measure Construct: Sensorimotor Upper Limb Function Domains: Hand Sensation, Strength of Upper Limb and Prehension Tasks. Multi-modality measure, consisting of five subtests.

Scoring Consists of five subtests (dorsal sensation, palmar sensation, strength of upper limb, prehension ability, prehension performance). Each subtest renders a numerical value that represents the impairment manifested at the periphery and spinal cord.

Reliability Inter rater and test retest reliability for all subtests within the measure are above 0.80.

Validity Construct Validity - Sensation and strength domains have greater sensitivity in defining the impairment of the upper

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limb than the current available measures for SCI. Concurrent Validity – The subtests within the measure hold concurrent validity with measures of function used with the SCI population (SCIM, CUE).

Uses of the Measure The intended use for GRASSP is as a clinical assessment of impairment of the upper limb after tetraplegia. The numerical values rendered by the measure can be used to establish relationships between impairment and function for individuals with the chronic tetraplegia.

The GRASSP characterizes the upper limb for individuals after tetraplegia and can be

used as early as an individual is responsive to being able to participate in clinicial

assessment. This allows impairment information to be extracted as soon as possible after

injury. Data collection early after injury allows one to establish a reliable baseline which can

be used to compare to subsequent assessments done in the same facility or across facilities.

Measuring the three separate domains adds value to upper limb assessment. Sensory

and motor domains define the neurological deficit as it relates to anatomy (dermatomes and

myotomes) and prehension defines how the deficits impact function. The relationships of the

three domains characterize the cause of the functional deficit. The GRASSP was not

designed to measure or evaluate compensation or one’s ability to accomplish a task, rather

how the task is performed and the quality of the performance. The value in the information

gathered by GRASSP allows one to understand more about the neurological integrity of the

upper limb and its impact on function, which may in turn allow clinicians and researchers to

understand how to influence the deficit. The multi domain feature of the GRASSP means the

measure can be used in two ways, one to test new approaches (determine what aspect of

deficit is influenced) and two, to follow the natural recovery process. The GRASSP provides

greater precision or sensory reporting than existing tests because of the use of Semmes

Weinstein Monofilaments, the strength testing provides greater robustness to the motor

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testing due to the testing of additional muscles. The prehension testing defines the

functionality of the neurological integrity. These features of the GRASSP make it a superior

impairment measure for use in clinical trials assessing neurological change in the upper limb.

Reliability of a measure is an important property in the evaluation of change over

time. As such, the reliability of the GRASSP defines it as a measure for use with the SCI

population to follow natural recovery and the effects of interventions. The construct validity

of the GRASSP ensures that the data collected represents sensation, strength and prehension

domains appropriately. Therefore, the GRASSP can be used in the assessment of impairment

with confidence that the domains assess with accuracy and precision.

Concurrent validity with the SCIM is moderate and positive and indicates as

impairment decreases, function and independence improve. Concurrent validity with the

CUE (self perception of function) was the strongest. This finding is significant because it

indicates at least in a chronic sample that “what” an individual reports about their function is

important and correlates with quantitative measures of impairment. The high level of

concurrence between GRASSP and CUE is significant because it provides credence of

consumer involvement in establishing whether the effect of interventions will be

meaningful..

The GRASSP renders data that characterizes the impairment of the upper limb with

greater detail than any available SCI specific measure to date. This enables researchers to

understand the process of spontaneous recovery, determine the effects of interventions and

make connections between impairment and function with greater accuracy, precision and

meaning.

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7.3 Limitations of the Project

Although this work presents a novel impairment measure of the upper limb for

individuals with tetraplegia, which has incorporated the many stages of measurement

development and shows substantial promise as a new outcome measure in the field, the work

also has limitations.

Limitations of the GRASSP itself are defined by the purpose of the measure. The

GRASSP has been designed as a clinical measure so implementation and access to the test is

simple and inexpensive. However, a clinical measure no matter how reliable always includes

some degree of human error. Implementation of the measure is clearly defined in the

instruction manual; however, administration of the measure may differ slightly due to the

level of understanding and preference of the clinicians administering the test.

Some of the concepts that were considered, but not included in the development of

the measure were stereognosis and haptics. Sensation after injury is often compensated for by

vision and the GRASSP does not account for visual input and its influence on performance.

Despite the sample size being sufficient for the reliability analysis; when the sample

was sub grouped into cervical levels according to ISCSCI the sub group numbers were not

large enough to confirm definitively some of the results noted. In order to conduct a more

rigorous statistical method such as: Rasch Analysis or Mokken Scale Analysis, to determine

the true predictability of the items and subtests, a much larger sample would be required.

The sample used in this study included individuals with chronic tetraplegia; therefore,

future results of similar analyses may differ with more acute individuals. Individuals with

chronic tetraplegia often develop compensatory patterns and functions otherwise known as

“maladaptative patterns”, which are not always accommodated for by the GRASSP.

Although, the prehension domain is designed to differentiate between maladaptive and

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normal movement patterns, individuals with chronic tetraplegia have very strong

compensatory behaviours which may not be deciphered from normal behaviours.

Furthermore, abilities to complete tasks in the GRASSP are based on experience through

activities of daily living. For individuals who live in the community many of the tasks are

familiar. Whereas individuals who are still acute would be challenged with the same tasks as

they may not have had the opportunity to practice or to perform them. This difference for

acute and chronic individuals may warrant slight modifications in scoring in the future.

The GRASSP was designed by incorporating many elements of physiology and SCI

pathology, however, being a clinical measure there are limitations with respect to how the

GRASSP measures impairment. The prehension performance subtest of the measure only

includes timing and scoring of tasks; force of prehension during tasks is not measured,

therefore, force generated could enlighten clinicians even more regarding what elements to

target in therapeutic interventions.

7.4 Future Directions

One remaining psychometric property, responsiveness, has not been established for

the GRASSP to date. A longitudinal study that will provide the data to evaluate the

responsiveness of the GRASSP is warranted. Currently, a longitudinal study to establish

responsiveness of the GRASSP is being conducted. The current trial includes serial testing

of individuals from the time of injury to one year post injury. The data will be used to

establish the responsiveness of the GRASSP, define a recovery profile of the upper limb after

tetraplegia, and establish elements of minimally clinical important difference. The trial will

provide data to determine the most appropriate scoring of the GRASSP for individuals during

the acute phase after tetraplegia; the impairment relationships to function throughout the

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continuum of recovery, which can inform clinical decision making; the temporal association

of recovery of the upper limb and how it influences function; and when the optimal

timeframe for intervention and type of modality might be.

This study focused on the development of GRASSP in traumatic tetraplegia.

However, individuals with non traumatic tetraplegia often present with similar upper limb

impairments. The GRASSP will be applied in two non traumatic SCI longitudinal studies to

examine the impairment changes that occur after surgical and drug interventions.

Modifications to the measure may be required to accommodate the non traumatic group.

7.5 Final Summary

What is currently lacking is an impairment measure with robust measurement

properties that assesses the domains most likely to change with new therapeutic interventions

which are directed towards neural repair and recovery. The GRASSP fills this void.The

GRASSP is a measurement tool used to determine the status of hand function which has the

psychometric properties to be implemented in upcoming studies investigating the

fundamental underlying mechanisms and state of integrated sensorimotor hand impairment.

When the sensitivity to detect change in sensorimotor impairment has been established, the

GRASSP will have the potential to be an important assessment tool to specifically detect

changes in sensorimotor function over the post injury process. In clinical trials where the

primary outcome of sensorimotor integration needs to be decoupled to determine efficacy of

interventions, the GRASSP will be useful to determine the integrated contribution of the

underlying neural substrates of sensation and motor function. This new knowledge gained

has the potential to characterize the effectiveness of sensory and motor therapeutic

interventions.

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Appendix 1

A: Initial GRASSP

B: GRASSP Version 1.0

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A: Initial GRASSP

GRADED and REDEFINED ASSESSMENT

Of STRENGTH, SENSIBILITY and PREHENSION

(Initial GRASSP)

Collaboration: Armin Curt, Susan Duff, Michael Fehlings Sukhvinder Kalsi-Ryan, Claudia Rudhe-Link, Molly Verrier, Lisa Ann Weurmser

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TABLE OF CONTENTS

Introduction 2

Purpose of the Measure 2

Design and Development of the GRASSP 2

Modules 2

Timelines for Testing 3

Instructions for implementation of the GRASSP 3

Upper Extremity ASIA 3

Strength 4

Muscle Tone 7

Sensibility 7

Prehension 9

Scoring Sheets 13

Demographics 13

Upper Extremity ASIA 13

Strength and Muscle Tone 14

Sensibility 15

Prehension 16

Summary and Total Scores 16

References 17

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INTRODUCTION Initiated by the North American Clinical Trials Network (NACTN) and the European Clinical Trials Network (EUCTN), a meeting was held on May 12 and 13, 2006 in Chicago (local organizer Drs. Zev Rymer and Lisa-Ann Wuermser, financially supported by the Christopher Reeves Foundation (CRF)) to discuss the measurement of hand impairment and function in patients suffering from cervical spinal cord injury (cSCI). Members of the networks and independent clinical specialists in hand measurement and therapy, as well as researchers with expertise in engineering and computer technology discussed the development of a comprehensive protocol to assess upper limb impairment and recovery post cSCI. The result of the meeting was a task force to further develop a clinical assessment protocol of hand function by modifying existing tools and introducing new measures that would allow for the quantification of change in hand function for individuals with cSCI. The GRASSP is a combined effort by six clinicians/researchers who have contributed their work (results of tool development through previous research, in some instances graduate studies), skills, and time. The GRASSP is a mosaic of the Link Hand Function Test (LiHFT) (Claudia Rudhe-Link, Zuerich, Switzerland), Testing of Strength & Muscle Tone (Susan Duff, Philadelphia, US), and The Tetraplegia Hand Measure (THM) (Sukhvinder Kalsi-Ryan, Toronto, Canada). PURPOSE OF THE MEASURE The overall objective for the assembly of the GRASSP was to develop a clinical research tool that could capture information on hand function from the cervical (C0-T1) spinal cord injury (SCI) population, obtain integrated sensory and motor impairment data, and discriminate the population according to the level of lesion. The purpose of this project was to design a hand function tool: 1) that was highly responsive (sensitive) to change over time; 2) that could assess the extent of spontaneous (natural) recovery; and 3) be applicable for use in clinical trials to evaluate the effect of novel interventions (pharmacological and surgical). DESIGN AND DEVELOPMENT OF THE GRASSP The GRASSP is a framework that assembles different clinical tools to measure the various aspects of complex sensori-motor hand function. The GRASSP is embedded with currently existing measures of upper limb function (ASIA motor and sensory scores of the upper limb) (Marino et al. 2002). It also includes clinical tools that should provide information useful for comparison to other upper limb testing protocols. For the development of the GRASSP each of the three modules was assigned to one of the measurement developers (Strength/Muscle Tone – Susan Duff, Sensibility- Sukhvinder Kalsi-Ryan, and Prehension – Claudia Rudhe-Link) under the direction of Armin Curt, Molly Verrier, and Lisa Ann Wuermser. Although, individuals were responsible for separate modules all members of the task force made significant contributions to all components of the GRASSP. MODULES The GRASSP is comprised of three separate modules, Strength/Muscle Tone, Sensibility, and Prehension. Multiple modules allow for a comprehensive assessment

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at multiple time points in the post-injury continuum. Each module can be tested according to the scheduled timeline provided by a trial protocol. TIMELINES OF TESTING The schedule provided below exemplifies how the tests could be sequenced in a given trial (Table 1 shows a potential scheduling of examinations). It’s possible that the very early period following SCI might be monitored by a subset or even different measures than in the advanced and chronic stages of SCI. Table 1: Time of Examination

Modules Impairment Impairment & Capacity Sub-acute – weeks Time of Examination Acute 72hrs-

10 days 4 8 12 24 52ASIA muscles X X X X X X Proximal Arm X* X X X X X Extrinsic Hand Muscles X X X X X Intrinsic Hand Muscles X X X X X

Strength & Muscle Tone

Muscle Tone/Modified Ashworth X X X X X ASIA sensory –LT/PP X X X X X X Semmes Weinstein Monofilaments X X X X X

Sensibility

Static Two Point Discrimination X X X X X Qualitative Grasp X X X X X X Prehension Quantitative Grasp X X X X X

5. Only to be tested if not contradicted by physician Modules – The modules complement the ASIA and functional (SCIM/FIM) testing. ASIA – ASIA items are shown in italic

INSTRUCTIONS FOR IMPLEMENTATION OF THE GRASSP: Consent: Always obtain consent from the subject (patient) and collect the necessary demographic data based on interview with the patient/family and chart review. Positioning the Patient: In acute period the patient is lying supine with both arms exposed to the shoulders and should be tested in this position. During most other testing sessions the subject should be seated in his/her own seating system with his/her appropriate supports. During all testing, the entire upper extremity should be exposed (up to the shoulder). An adjustable table which can move in and out of wheelchair space will be required to perform the assessment. The subject’s hands should be positioned on the table, with approximately 30 degrees of shoulder flexion, 65 to 70 degrees of elbow flexion and the hands and distal half of the forearms supported on the table. This position can be modified slightly to ensure comfort for the individual being tested. The room where the testing will be done should be well lit. Length of the Testing: The time required to complete all of the tests in one session is approximately 45 – 60 minutes (depending on patient ability). It is not recommended to break the testing up into two sessions over two days as individual’s response can vary and recovery can potentially affect the results. For the best outcome it is recommended to complete the testing in one session, however, between tests the individual and the examiner can break and stretch.

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UPPER EXTREMITY ASIA: Muscle Testing: All of the ASIA muscles are tested within the required GRASSP muscles, therefore, refer to the instructions in the Strength and Tone section and use the scale also. Light Touch and Pinprick: Prepare the patient as above. A safety pin and cotton swab should be applied to test locations as per ASIA standards (Marino et al. 2002). Dermatomes C2 to T1 should be tested for the purpose of this work. The specific locations (dorsal aspect of the hand at position 1, 2 and 3) are amplified in Figure 1. The response is then recorded as intact, impaired or absent as described in Table 2. Pinprick testing is confirmed by performing dull/sharp testing and determining if sharp is intact. If there is uncertainty then dull/sharp should be repeated up to 10 times for one location to be certain of the sensation. Figure 1: ASIA Sensory Test Locations, labeled by dermatome

STRENGTH and MUSCLE TONE

Muscles specific to the upper limb and hand were added to the ASIA repertoire of testing to establish greater sensitivity to potential change post-injury. Strength will be assessed with Manual Muscle Testing (MMT). An isotonic muscle contraction will be required by the subject to grade muscle strength. Specifically, resistance should be given at the distal end of the moving bone while the subject moves the limb through the specific range (Daniels and Worthingham, 1995). Muscle tone will be assessed using the Modified Ashworth Scale (Bohannon and Smith, 1987). The following tables define the scaling for the two tests, the muscles to be tested and the instructions for testing each muscle. Muscle Testing Prior to beginning muscle testing the subject should be oriented to the test by demonstration on an active body part. If the testing will be done in supine the examiner should stand comfortably at the bedside. If the subject is seated, the examiner may choose to stand next to the wheelchair or sit next to/across from them.

Response Normal Feels stimulus but not the same as normal location

No response

Response Label

Normal Impaired Absent

Score 2 1 0

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During assessment of the distal arm musculature the subjects’ distal forearm should rest on an adjustable table. Begin by testing the muscle for a grade three (range against gravity), ensuring the joints are isolated. If the individual is able to move through full range of motion (ROM) against gravity then the same movement should be tested with resistance for a grade 4 or 5 through full ROM. The examiner will grade the individual according to the scoring key. Resistance is given at the distal end of moving the bone during an isotonic contraction. Table 2 defines the muscles to be tested and the stabilization and resistance required for testing these muscles and the scoring key to be used. Remember that for finger muscles gravity does not have an effect, which defines grade 2 as: movement of the corresponding body part but not through the full range of motion and grade 3 as: movement through full ROM. All MMT scoring should be recorded on the score sheets in the next section. Note: 1) Range of motion for anterior deltoid is considered to be to 90 degrees of elevation and MMT scoring should be based on 90 degrees of elevation as full ROM. 2) For elbow extension if the starting position (full elevation) is not feasible then elbow extension can be tested in 90 degrees of shoulder elevation. Table 3: Strength Testing and Instructions Muscle Action Nerve

Radicular segments

Action Stabilization Starting position

Resistance Point

Anterior Deltoid

Arm elevation for reaching & pointing

Axillary n C5-6

Shoulder abduction – 90°/ flexion in supine

Trunk 00 shoulder adduction/ flexion

Anterior, distal humerus

Elbow extensors

Reaching Radial n C6-C8

Extend elbow

Humerus Elbow flexion, shoulder abduction (hand behind the head, or 90° abd and full inward rotation of the humerus

Distal forearm

Elbow flexors

Hand to face/mouth, bring objects toward trunk

Musculo- Cutaneous C5-6

Flex elbow Humerus Full Elbow extension, shoulder adduction, forearm in supination

Distal, volar forearm

Wrist extensors

Stabilize for prehension, Orienting hand to grasp

Radial n C6-C8

Extend wrist

Forearm Wrist in flexion, forearm in pronation

Distal, dorsal 3rd metacarpal

Extensor Digitorum

Hook grasp, Object release

Radial n C6-C8

Extend MP’s digits 2-5

2-5 Metacarpals

Flexion IP’s / MP’s digits 2-5, forearm in pronation (fingers hanging over

Dorsal Proximal phalanges digits 2-5

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edge of table)

Finger flexors (3rd FDP)

Pad to pad (3-jaw chuck), Cylindrical Grip, Hook Grasp

Median n C7-T1

Flex DIP joint of 3rd digit

MP, PIP joint 3rd digit

3rd digit DIP extension, 3rd PIP/MP supported in 00 extension on table

3rd volar finger pad

Flexor Pollicis Longus

Spherical Grasp, Lateral Pinch, Tip to Tip Pinch

Median n C6-C8

Flex thumb IP joint

Thumb Proximal phalanx/ metacarpal

00 thumb IP extension, MP supported in 00 extension

Volar thumb pad

Finger abductors (5th)

Spherical Grasp, Cylindrical grasp

Ulnar n C8-T1

Abduct 5th digit

5th metacarpal

5th digit adducted, MP’s extended, forearm in pronation

Distal, ulnar, 5th proximal phalanx

First Dorsal Interossei

Spherical grip, Lateral Pinch

Ulnar n C8-T1

Abduct index

2nd metacarpal

Index adducted next to long finger, MP’s extended, forearm in pronation

Distal, radial, 2nd proximal phalanx

Adductor Pollicis Brevis

Lateral Pinch Ulnar n C8-T1

Adduct toward index

Wrist/ forearm

Thumb abduction, wrist and forearm in supination

Distal, ulnar, thumb proximal phalanx

Opponens Pollicis

Tip to Tip, Pad to Pad, Spherical grasp, Cylindrical grasp

Median n C6-C7

Rotate 1st metacarpal toward 5th digit pad

wrist/ 2-5 metacarpals

Thumb in a resting posture against 5th metacarpal, wrist and forearm in supination

Distal, volar proximal phalanx with derotating pressure

ASIA Muscles in italics (Daniels and Worthingham, 1995; Kendall, McCreary, and Provance, 1993) Table 4: Scoring Key for Manual Muscle Testing

0 Absent – No palpable muscle contraction 1 Trace – Palpable Muscle Contraction 2 Poor – Moves full ROM with gravity eliminated 3 Fair – Moves full ROM against gravity without added resistance 4 Good – Moves through full ROM against gravity against moderate resistance 5 Normal – Moves through full ROM against gravity against maximal resistance

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MUSCLE TONE Muscle tone will be assessed during passive range of motion (PROM) of the limbs and evaluated using the Modified Ashworth Scale as per the following instructions (Bohannon and Table 5: Muscle Tone Testing, Instructions and Scoring Key Muscle Action Test Regime Elbow Flexors Reaching to mouth Passively extend the elbow Finger Flexors Grasp Passively extend the fingers

Scoring for Muscle Tone 5 No increase in muscle tone 4 Slight increase in muscle tone, manifested by a catch and release or minimal

resistance at the end of movement (ROM) when the affected part is moved in flexion or extension

3.5 Slight increase in muscle tone, manifested by a catch following resistance throughout the remainder (less than half of ROM)

3 More marked increase in muscle tone through most of the ROM but affected part is easily moved

2 Considerable increase in muscle tone, passive movement difficult 1 Affected part rigid in flexion or extension 0 Unable to test

SENSIBILITY Sensory testing should always be conducted in a room that is at a comfortable temperature (as close to room temperature as possible). When applying the stimulus to the hands the examiner must ensure that he/she does not touch the hand as this can alter the individual’s ability to sensate accurately. Prior to beginning the testing the subject should be oriented to the test by demonstration on an area of intact sensation such as the face. The examiner will be standing beside the bed or seated across from the subject. The test is performed with the subjects eyes closed or occluded. The forearm and hand should be supported in supination or pronation with a towel or a pillow (not with the examiners hands). A circumferential 2 inch �elcro strap may be used to secure the hand to the pillow allowing for access to the palm and finger tips during the second part of the testing. Semmes Weinstein Monofilaments (SWM) – The monofilaments should be applied to the 6 points distal to proximal (test points 1 to 6 in Figure 2). The filament should be applied until it bends: applying for 1.5 seconds, holding for 1.5 seconds, and removing for 1.5 seconds. Filament 3.61 is to be applied three times at all test locations, 2/3 positive responses indicates intact sensibility of that force. The assessor should determine if the participant has sensation by asking “do you feel a touch?” and following by “where do you feel the touch?”. The remaining three filaments are applied once. The first filament which is applied three times, all dorsal test locations (points 1-3) can be tested once and then repeated in the same order, and then repeated a third time, after that, the hand can be turned and the palmar side of the hand can be tested in the same way. After recording all three applications of the filament 3.61, it can be determined if the test location is positive to that filament. Delayed responses more than three seconds are abnormal. The 3.61 filament is first

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used in all test locations. If the patient feels the filament in all areas the examination is complete. It will not be necessary to use the other filaments. If the patient does not respond to the 3.61 filament the next heavier filament is used. Only test locations which do not respond to the previous filament need to be tested with the next filament. The exam continues until the patient recognizes a force in all test locations or until it is established that he/she does not feel even the heaviest filament. When the response is positive for a particular filament a check can be put in the associated box. When all the test locations have been tested the filament force should be written into the final box labeled g/F followed by the associated score in the score box (see Table 6). Figure 2: Diagram for Sensibility Test Locations

Table 6: Scoring of Pressure Sensibility with the Semmes Weinstein Monofilaments

Static Two Point Discrimination (S2PD) – The examiner should begin with the 5mm stimulus and apply it to each point (test locations 7 to 9, Figure 2) and record whether the individual detects 1 or 2 points, by asking the participant if they feel one or two points. A lateral hold of the digit might be necessary, which should be applied at the IP joint of the digit. The examiner records nothing in the box if the individual does not detect two points and a check mark if he/she does. If the subject feels two points then move to the next test location and proceed. If the subject feels only one point then the examiner should apply the next level of stimulus to the same test location and repeat this pattern until there is a positive response for the location or there is no response at the last level of stimuli. Complete one point before moving to the next point. At the end of the testing record the associated score in the appropriate box as per Table 7. Table 7: Scoring of the Static Two Point Discrimination Discriminator Distance 5mm 8mm 12mm 15mm No response Score 4 3 2 1 0

Filament Label

3.61 4.31

4.56

6.65 No Respon

se Filament Force

0.217

g/F

2.35

g/F

4.19

g/F

279.4

g/F

No Respon

se Score 4 3 2 1 0

Semmes Weinstein Monofilaments Static Two Point Discrimination

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PREHENSION Prehension is assessed both qualitatively and quantitatively. Qualitative Prehension The aim of this subsection is to ensure that the early movement is captured before an individual may be ready for a seated assessment. No specific positioning of the patient is required, but appropriate positioning of the hand for movement should be ensured. The patient is asked to form the following prehension patterns with each hand separately. The requested movement and grasp patterns can be demonstrated by the examiner. The purpose of this testing is to establish which components of the finger-hand-forearm can be actively or passively positioned and directed to allow a grasp function and if the movement is wrist dominant. The intent is to establish whether the participant can perform a limited movement that does or does not include the components to develop an active grasp. The assessor should be looking to isolate, wrist, fingers and thumb. The basic pattern for grasping might be visible although the patient yet can not quite grasp. Table 8: Qualitative Grasp, Instructions and Scoring Qualitative Grasps

Muscles Myotome Task

Cylindrical Grasp FDS, FDP, OPPONENS

C7-T1 Neutral wrist position and finger movements performed with gravity eliminated

Lateral Key Pinch

ADP, FPL, Index FDS

C6-T1 Neutral wrist position and finger movements performed with gravity eliminated

Tip to Tip Pinch Index FDP, OPPONENS

C7-T1 Neutral wrist position and finger movements performed with gravity eliminated

Scoring: 0 – Subject is not able to position the wrist or fingers in any specific pattern for the requested grasp. 1 – Subject is able to move the wrist actively and fingers passively assume the requested prehension pattern or the subject is able to begin a potential grasp with use of the wrist and no subsequent finger movement. 2 – Subject is able to partially or completely move the fingers actively into the requested prehension pattern (combination of wrist movement and intrinsic hand muscle activation) but fails to generate force because the grasp is acquired through passive positioning from the activating the wrist. 3 – Subject is able to actively position the fingers and/or thumb into the requested prehension pattern with normal wrist movement for a grasp, touching the opposite finger(s) or the palm with some noticeable active force. 4 – Subject is able to perform the grasp with normal strength (like in a normal shaking hand)

Quantitative Prehension Patient positioning · The patient is positioned in a sitting position symmetrically in front of a table. Additional support for trunk stability is allowed. This includes for example the use of a belt but also sitting in bed supported by the back rest or using the bed side table to set up the test.

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· A change in position, concerning the person’s angle to the table, is not allowed during the standardised test administration. · The patient is asked to use his favourite grasping form when performing the tasks. · The test is conducted twice, for each hand individually. · The stabilisation of the objects/test board, if necessary, is done by the examiner. · The test board is placed parallel to the edge of the table, in front of the patient. Moving the board in a parallel line to the table’s edge is permitted. Turning or rotating of the board is not permitted (see picture). · All other items are placed on the table in front of the patient. Procedure The required material for the different tasks is placed on the table in front of the patient just prior to the performance of each task. Prior to the first test administration, the patient is allowed to perform each task once as a rehearsal, without being scored. This will allow familiarization with the task and reduce the learning effect. The rehearsal time is limited to 1 minute for each task. The precise administration procedure for each task can be found in the table below. The examiner clocks the time required to accomplish each task. The clocking starts at a clear signal “start” and ends when the task is fully completed. The material can only be touched or grasped after the “start” signal. The initiation of each task is defined by clear activity, such as moving pegs, lifting up coins, manipulating the bottle of water in the hand. To score a 1 at least one part of the task must be done i.e. lifting up a coin, grasping and/or moving a coin, holding/lifting the bottle. Only moving the hand is not regarded as “done part of the activity”, neither is just placing the hand on the test equipment. The examiner observes task performance focussing on the form of the grasp. The time required for task performance is recorded on the score sheet and the task is scored according to the scoring key in Table 9. Grasp performance leads to a score with an associated time that is recorded separately. The maximum score for each task is 5 points with a maximal total score of 60 points. To judge the quality of the performance, the examiner must refer to the description of the “expected performance”. This description defines the typical form of grasp used and performance with an unaffected hand (see Table 9). One minute and 15 seconds is allowed for the completion of each task, if the individual is unable to complete the task within 1 minute and 15 seconds score accordingly and move on to the next task. Dropping of objects: If a patient drops an object and it falls onto the table, still reachable for the patient to retrieve, the task is continued without stopping the clock (In North America the drops are counted and the number is entered in the # of drops column). If the object falls onto the floor or the lap of the patient and cannot be reached by the patient, the clock is stopped. The examiner can pick up the object and the task may be repeated. If the drop lands again on the floor or lap of the patient during the repeated execution, the task is judged as “not conducted” (0 points) and comments are noted.

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Table 9: Quantitative Grasp, Instructions and Scoring Task / Instruction “Expected Normal” Performance

5. Take the bottle and pour the water into the cup, approx. ¾ full.

(lower rim of the black plastic ring)

Cylindrical grasp

The filled, already opened bottle (0.5L) and the cup are placed onto the table in front of the patient. ¾ filled corresponds to the lower rim of the black plastic ring around the cup. The task is completed if the water is poured in the cup and cup and bottle are put back down onto the table. The cup is stabilized by the examiner. 2. Unscrew the lids of the 2 jars and place them on the table.

Spherical grasp

The two jam jars are placed onto the table in front of the patient. The lids should sit tightly on the jar but should not require much strength to be opened (check before task administration!). The task is completed when both lids and jars lay on the table. The jars are stabilized by the examiner. 3. Pull the 9 pegs, one by one, out of the block and place them back into the markings on the opposite side.

Pad to Pad Prehension / Tripod pinch

The peg board is placed on the table in front of the patient. It does not matter if the pegs are moved from right to left or left to right; the patient can choose his preference. The task is completed when all 9 pegs are placed in the opposite board. The board is stabilized by the examiner or use of dycem. 4. Take the key from the table, insert it in the lock and turn it 90°.

Picking up the key from the table or sliding it over the table’s edge and putting it into the slot using Lateral Pad to Pad Prehension

The test board is placed on the table, parallel to the table’s edge, in front of the patient. The distance from the table’s edge to the test board is not important. The key is put on the table in front of the patient. The turning direction of the key is of no importance. The task is completed when the key was rotated 90°. The board is stabilized by the examiner or use of dycem.

5. Pick up the 4 coins, one by one, from the table and put them through the slot.

Picking up the coins from the table or sliding them over the table’s edge and putting them into the slot using Pad to Pad Prehension

The position of the test board is as described for task no. 4. The coins are placed side by side onto the table in front of the patient. The task is completed when all coins are dropped into the slot. The board is stabilized by the examiner or use of dycem. 6. Pick up the 4 nuts, one by one, from the table and screw them onto the matching screws.

Picking up nuts from table or sliding them over the table’s edge and screwing using Pad to Pad Prehension or Tip to Tip Prehension

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The position of the test board remains the same as described for task no.4 and 5. The 4 nuts are placed side by side onto the table in front of the patient. The task is completed when all nuts are screwed onto the matching screws, the screw’s-end aligned with the nuts. Rotating the test board is not permitted in this task either. The board is stabilized by the examiner or by dycem. Scoring (a maximum of 1 minute and 15 seconds is allowed for each task) 0-the task can not be conducted at all 1 – the task can not be completed, (less than 50% of the task) and the expected grasp is not used 2 – the task is not completed, (50% or more of the task) and the expected grasp is not used 3 – the task is conducted (completed) using tenodesis or an alternative grasp other than the expected grasp 4 – the task is conducted using the expected grasp with difficulty (lack of smooth movement or difficult slow movement) 5 – the task is conducted without difficulties using the expected grasping pattern and unaffected hand function Note: 50% of task 1 is when the participant has begun to pour the water, 50% or task 4 is when the participant is able to get the key to insertion point.

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SCORING SHEETS 1 – Demographics Subject ID: Assessment Number (circle)

1 2 3

Assessor ID: (circle) 1 2 Date Patient Name Age Gender Hand Dominance Pre-injury Post-injury Injury Date Injury Type Brief Description

Surgery and Date

Comments

ASIA Classification Motor Level R

Motor Level L

Sensory Level R

Sensory Level L

Motor Score R

Motor Score L

Sensory Score R

Sensory Score L

CUE Score SCIM Score 2 – ASIA Upper Extremity Scoring Myotome/ Dermatome Myotome LT-Dermatome PP-Dermatome

ASIA Level Right Left Right Left Right Left C2 C3 C4

C5 elbow flexor C6 wrist extensor

C7 Elbow extensor C8 Finger flexor

T1 Finger abductors Totals

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3 – Strength – score 0 to 5 as per instructions; enter 0 to 5 in each box

Muscle Tone – score 0 to 5 as per Modified Ashworth Scale, Enter 0 to 5 in each box.

Right Muscle Group Left (T1-R) Elbow flexors (T1-L)(T2-R) Finger flexors (T2-L)(TT-R) Total out of 10 per arm (TT-L)

Manual Muscle Testing RIGHT MUSCLE GROUP LEFT

(ST1-R) Anterior Deltoid C5/6 (ST1-L)(ST2-R) Elbow Extensors C7 (ST2-L)(ST3-R) Elbow Flexors C5 (ST3-L) Proximal Arm (ST4-R) Wrist Extensors (ST4-L)(ST5-R) Extensor Digitorum (DIII) (ST5-L)(ST6-R) Finger Flexors (DIII) (ST6-L)(ST7-R) Flexor Pollicis Longus (ST7-L) Extrinsic Hand Muscles (ST8-R) Finger Abductors (ST8-L)(ST9-R) First Dorsal Interossei (ST9-L)(ST10-R) Adductor Pollicis Brevis (ST10-L)(ST11-R) Opponens Pollicis (ST11-L) Intrinsic Hand Muscles (Stotal-R) Total out of 55 per arm (Stotal-L)

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4 – SENSIBILITY Monofilament and Two Point Discrimination Test Scores 4.1 SWM Threshold Sensed Right Hand AREA 3.61(4) 3.61(4) 3.61(4) 4.31(3) 4.56(2) 6.65(0) NR(0) Score

1 (S1-R)

2 (S2-R)

3 (S3-R)

4 (S4-R)

5 (S5-R)

6 (S6-R)

Total out of 24 (SWMT-R)

4.2 SWM Threshold Sensed Left Hand AREA 3.61(4) 3.61(4) 3.61(4) 4.31(3) 4.56(2) 6.65(0) NR(0) Score

1 (S1-L)

2 (S2-L)

3 (S3-L)

4 (S4-L)

5 (S5-L)

6 (S6-L)

Total out of 24 (SWMT-L)

4.3 Static Two Point Discrimination Sensed Right Hand

AREA 5mm (4) 8mm (3) 12mm (2)

15mm (1)

NR (0) Score

7 (S7-R)

8 (S8-R)

9 (S9-R)

Total out of 12 (2PDT-R)

4.4 Static Two Point Discrimination Sensed Left Hand

AREA 5mm (4) 8mm (3) 12mm (2)

15mm (1)

NR (0) Score

7 (S7-L)

8 (S8-L)

9 (S9-L)

Total out of 12 (2PDT-L)

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5 – PREHENSION 5.1 – Qualitative Grasp

Right Qualitative Grasps Left (QLG1-R) Cylindrical Grasp (QLG1-L)(QLG2-R) Lateral Key Pinch (QLG2-L)(QLG3-R) Tip to Tip Pinch (QLG3-L)(QLT-R) Total out of 12 (QLT-L) 5.2 – Quantitative Grasp Task/ Instruction Expected

Prehension Time Right

Score Right

Drops Right

Time Left

Score Left

Drops Left

1. Take the bottle and pour the water into the cup, approx. ¾ full.(lower rim of the black plastic ring)

Cylindrical grasp

(TR-1) (QN1-R) (TL-1) (QN1-L)

2. Unscrew the 2 lids of the jam jars and put them onto the table.

Spherical grasp

(TR-2) (QN2-R) (TL-2) (QN2-L)

3. Pull the 9 pegs, one by one, out of the foam and stick them back into the markings on the opposite side.

Tip to Tip Prehension

(TR-3) (QN3-R) (TL-3) (QN3-L)

4. Take the key from the table, insert it in the lock and turn it 90°.

Lateral Pad to Pad Prehension

(TR-4) (QN4-R) (TL-4) (QN4-L)

5. Pick up the 4 coins, one by one, from the table and put them through the slot.

Pad to Pad Prehension.

(TR-5) (QN5-R) (TL-5) (QN5-L)

6. Pick up the 4 nuts, one by one, from the table and screw them on the matching screws.

Pad to Pad Prehension or Tip to Tip Prehension

(TR-6) (N6-R) (TL-6) (QN6-L)

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6 SUMMARY AND TOTAL SCORES Right Left

STRENGTH-Upper limb (55/55) MUSCLE TONE – Elbow/Finger Flexors (10/10) SENSIBILITY ASIA – LT (16/16) SENSIBILITY ASIA – PP (16/16) SENSIBILITY Pressure – Monofilaments (24/24) SENSIBILITY Two Point Discrimination (12/12) PREHENSION – Qualitative Grasp (12/12) PREHENSION – Quantitative Grasp (30/30) TOTAL SCORE-(175/175)

REFERENCES 1. Marino, R.J., Barros, T., Biering-Sorensen, F., Burns, S.P., Donavan, W.H., Graves, D.E., Haak, M., Hudson, L.M., and Priebe, M.M. International Standards for Neurological Classification of Spinal Cord Injury. Sixth Edition 2002. 2. Mackin, E., Callahan, A., Skiver, T., Schneider, L. & Osterman, A. (2002) Hunter-Mackin-Callahan Rehabilitation of the Hand and Upper Extremity, Fifth Edition. St. Louis, Missouri: Mosby. 3. Daniels L, Worthingham C. (1995). Daniels and Worthingham’s Muscle Testing: Techniques of Manual Examination, 6th Ed. Philadelphia: WB Saunders Co. 4. Bohannon RW, and Smith MB. (1987). Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys. Ther. 67(2): 206-7. 5. Kendall F, McCreary EK, Provance PG. (1993). Muscles: Testing and Function, 4th Ed. Philadelphia: Williams & Wilkins.

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B: GRASSP Version 1.0

GRADED and REDEFINED ASSESSMENT

Of STRENGTH, SENSIBILITY and PREHENSION Version 1.0

(GRASSP Version 1.0)

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International GRASSP Research and Design Team: Sukhvinder Kalsi-Ryan University of Toronto, Graduate Department of Rehabilitation Science Toronto Western Hospital Toronto Rehabilitation Institute Armin Curt University of British Columbia Vancouver Coastal Health ICORD Susan Duff Thomas Jefferson University Michael Fehlings Toronto Western Hospital, Krembil Neuroscience Program University of Toronto Claudia Rudhe Balgrist University Hospital, Zürich Molly Verrier University of Toronto, Department of Physical Therapy Toronto Rehabilitation Institute Funding: Christopher and Dana Reeve Foundation, Rick Hansen Foundation, Toronto Rehabilitation Institute Student Scholarship Fund Supporting Organizations: North American Clinical Trials Network, European Clinical Trials Network, ICORD, Krembil Neurosciences Centre

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TABLE OF CONTENTS

GRASSP Design Team 1

Introduction 3

Purpose of the Measure 3

Design and Development of the GRASSP 3

Modules 4

Instructions for implementation of the GRASSP 4

Strength 4

Sensibility 7

Prehension 8

Scoring Sheets 13

Demographics 13

Strength 13

Sensibility 14

Prehension 15

Summary and Total Scores 16

References 16

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INTRODUCTION Initiated by the North American Clinical Trials Network (NACTN) and the European Clinical Trials Network (EUCTN), a meeting was held on May 12 and 13, 2006 in Chicago (local organizer Drs. Zev Rymer and Lisa-Ann Wuermser, financially supported by the Christopher and Dana Reeve Foundation) to discuss the measurement of hand impairment and function in patients suffering from cervical spinal cord injury (cSCI). Members of the networks and independent clinical specialists in hand measurement and therapy, as well as researchers with expertise in engineering and computer technology discussed the development of a comprehensive protocol to assess upper limb impairment and recovery post cSCI. The result of the meeting was a task force to further develop a clinical assessment protocol of hand function by modifying existing tools and introducing new measures that would allow for the quantification of change in hand function for individuals with cSCI. The GRASSP is a combined effort by six clinicians/researchers who have contributed their work (results of tool development through previous research, in some instances graduate studies), skills, and time. The GRASSP is a mosaic of the Link Hand Function Test (Link, 2004) and The Tetraplegia Hand Measure (Kalsi-Ryan et al. 2004). PURPOSE OF THE MEASURE The overall objective for the assembly of the GRASSP was to develop a clinical research tool that could capture information on hand impairment from the cervical (C0-T1) spinal cord injury (SCI) population, obtain integrated sensory and motor impairment data, and discriminate the population according to the level of lesion. The purpose of this project was to design a hand impairment tool: 1) that was highly responsive (sensitive) to change over time; 2) that could assess the extent of spontaneous (natural) recovery; and 3) be applicable for use in clinical trials to evaluate the effect of novel interventions (pharmacological and surgical). The GRASSP is recommended for use in the very early acute phases out to approximately one year post injury. Use of the GRASSP is recommended when a change in neurological status is being assessed. DESIGN AND DEVELOPMENT OF THE GRASSP The GRASSP is a framework that assembles different clinical tools to measure the various aspects of complex sensori-motor hand function. The GRASSP is embedded with currently existing measures of upper limb function. For the development of the GRASSP each of the three modules was assigned to one of the measurement developers (Strength – Susan Duff, Sensibility- Sukhvinder Kalsi-Ryan, and Prehension – Claudia Link-Rudhe) under the direction of Armin Curt and Molly Verrier. Although, individuals were responsible for separate modules all members of the task force made significant contributions to all components of the GRASSP. MODULES The GRASSP is comprised of three separate modules, Strength, Sensibility, and Prehension. Multiple modules allow for a comprehensive assessment at multiple time points in the post-injury continuum. Each module can be tested according to the scheduled timeline provided by a trial protocol. INSTRUCTIONS FOR IMPLEMENTATION OF THE GRASSP: Consent: Always obtain informed consent from the subject (patient) and collect the necessary demographic data based on interview with the patient/family and chart review. Positioning the Patient: In the acute period the patient is lying supine with both arms exposed to the shoulders and should be tested in this position. During other test sessions the subject should be seated in his/her own seating system with his/her appropriate supports. During all testing, the entire upper extremity

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should be exposed (up to the shoulder). An adjustable table which can move in and out of wheelchair space will be required to perform the assessment. The subject’s hands should be positioned on the table, with approximately 30 degrees of shoulder flexion, 65 degrees of elbow flexion and the hands and distal half of the forearms supported on the table. This position can be modified slightly to ensure comfort for the individual being tested. The room where the testing will be done should be well lit. Length of the Testing: The time required to complete all of the tests in one session is approximately 30 - 45 minutes (depending on patient ability). It is not recommended to break the testing up into two sessions over two days as an individual’s response can vary and recovery can potentially affect the results. For the best outcome it is recommended to complete the testing in one session, however, between sub-tests the individual and the examiner can break and stretch. In the early phases of injury (0-21 days) it is recommended to only perform the partial GRASSP which consists of the sensory, strength and qualitative prehension portions (15-20 minutes) of the test. After the early phase the full GRASSP is recommended. STRENGTH Muscles specific to the upper limb and hand were added to the ASIA (Marino et al. 2004) repertoire of testing to establish greater sensitivity to potential change post-injury. Strength will be assessed with Manual Muscle Testing (MMT) (Daniels & Worthington, 1995). An isotonic muscle contraction will be required by the subject to grade muscle strength. Specifically, resistance should be given at the distal end of the moving bone while the subject moves the limb through the specific range (Daniels and Worthingham, 1995). The following table defines the scaling for the muscle testing and the instructions for testing each muscle. Muscle Testing Prior to beginning muscle testing the subject should be oriented to the test by demonstration on an active body part. If the testing will be done in supine the examiner should stand comfortably at the bedside. If the subject is seated, the examiner may choose to stand next to the wheelchair or sit next to/across from them. During assessment of the distal arm musculature the subjects’ forearm should rest on an adjustable table. Begin by testing the muscle for a grade three (range against gravity), ensuring the joints are isolated. If the individual is able to move through full range of motion (ROM) against gravity then the same movement should be tested with resistance for a grade 4 or 5 through full ROM. The examiner will grade the individual according to the scoring key. Resistance is given at the distal end of the moving bone during an isotonic contraction. Table 1 defines the muscles to be tested, the starting position, the stabilization and resistance required for testing these muscles and the scoring key to be used. Remember that for finger muscles gravity does not have an effect, which defines grade 2 as: movement of the corresponding body part but not through the full range of motion and grade 3 as: movement through full ROM. All MMT scoring should be recorded in the scoring sheets section. Note: 1) Full range of motion for anterior deltoid should be established and then measured based on available range (available should be considered full range). 2) For elbow extension if the starting position (full elevation) is not feasible then elbow extension can be tested in 90 degrees of shoulder elevation.

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Table1: Strength Testing and Instructions

ASIA Muscles in Italics (Daniels and Worthingham, 1995; Kendall, McCleary and Provance, 1993)

Muscle Action Stabilization Starting position Resistance Anterior/Mid Deltoid C5-6

Shoulder abduction 90°/ flexion in supine

Trunk 00 shoulder abduction/ flexion Anterior, distal humerus

Elbow flexors (Biceps) C5-6

Flex elbow Humerus Full Elbow extension, shoulder adduction, forearm in supination

Distal, volar forearm

Elbow extensors (Triceps) C6-C8

Extend elbow Humerus Elbow flexion, shoulder abduction (hand behind the head, or 90° abd and full inward rotation of the humerus

Distal forearm

Wrist extensors C6-C8

Extend wrist Forearm Wrist in flexion, forearm in pronation

Distal, dorsal 3rd metacarpal

Extensor Digitorum C6-C8

Extend MP's digits 2-5

2-5 Metacarpals

Flexion IP's / MP's digits 2-5, forearm in pronation (fingers hanging over edge of table)

Dorsal Proximal phalanges digits 2-5

Opponens Pollicis C6-C7

Rotate 1st metacarpal toward 5th digit pad

wrist/ 2-5 metacarpals

Thumb in a resting posture next to 2nd metacarpal, slightly abducted, forearm in supination

Volar proximal phalanx with derotating pressure

Flexor Pollicis Longus C6-C8

Flex thumb IP joint

Thumb Proximal phalanx/ metacarpal

00 thumb IP extension, MP supported in 00 extension

Volar thumb pad

Finger flexors (3rd FDP) C7-T1

Flex DIP joint of 3rd digit

MP, PIP joint 3rd digit

3rd digit DIP extension, 3rd PIP/MP supported in 00 extension on table

3rd volar finger pad

Finger abductors (5th) C8-T1

Abduct 5th digit

5th metacarpal 5th digit adducted, MP’s extended, forearm in pronation. (Position hand on sheet of paper to reduce friction)

Ulnar side of inter-phalangeal joint of 5th digit

First Dorsal Interossei C8-T1

Abduct index 2nd metacarpal Index adducted next to long finger, MP’s extended, forearm in pronation (Position hand on sheet of paper to reduce friction on the table)

Radial side of inter-phalangeal joint of 2nd phalanx

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Table 2: Scoring for Manual Muscle Testing

SENSIBILITY Sensory testing should always be conducted in a room that is at a comfortable temperature (as close to room temperature as possible). When applying the stimulus to the hands the examiner must ensure that he/she does not touch the hand as this can alter the individual’s ability to sensate accurately. Prior to beginning the testing the subject should be oriented to the test by demonstration on an area of intact sensation such as the face. The examiner will be standing beside the bed or seated across from the subject. The test is performed with the subjects eyes closed or occluded. The forearm and hand should be supported in supination or pronation with a towel or a pillow (not with the examiners hands). A circumferential 2 inch Velcro strap may be used to secure the hand to the pillow allowing for access to the palm and finger tips during the testing. Semmes Weinstein Monofilament Testing (SWM) The monofilaments should be applied to all 6 points (test points 1 to 6 in Figure 1). The filament should be applied until it bends: applying for 1.5 seconds, holding for 1.5 seconds, and removing for 1.5 seconds. Filament 3.61 is to be applied three times at all test locations, 2/3 positive responses indicates intact sensibility of that force. The assessor should determine if the participant has sensation by asking “do you feel a touch?” and following by “where do you feel the touch?” It the patient is not able to adequately localize the stimulus then he/she is not feeling the applied stimulus. The remaining three filaments are applied once. The test is started on the dorsal side of the hand. The first filament (3.61) is applied three times; all dorsal test locations (points 1-3) can be tested before moving to the palmar test locations (4-6). Delayed responses of more than three seconds are abnormal. If the patient feels the first filament in all areas the examination is complete. It will not be necessary to use the other filaments. If the patient does not respond to the 3.61 filament the next heavier filament is used. Only test locations which do not respond to the previous filament need to be tested with the next filament. The exam continues until the patient recognizes a force in all test locations or until it is established that he/she does not feel even the heaviest filament. When the response is positive for a particular filament a check can be put in the associated box. When all the test locations have been tested the filament force should be scored appropriately into the final box score. Table 3 defines the score associated to the log label of the monofilament (Mackin et al. 2002).

0 Absent – No palpable muscle contraction 1 Trace – Palpable Muscle Contraction 2 Poor – Moves full ROM with gravity eliminated 3 Fair – Moves full ROM against gravity without added resistance 4 Good – Moves through full ROM against gravity against moderate resistance 5 Normal – Moves through full ROM against gravity against maximal resistance

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Figure 1: Diagram for Sensibility Test Locations

Table 3: Scoring of Pressure Sensibility with Semmes Weinstein Monofilaments

PREHENSION Prehension is assessed both qualitatively and quantitatively. A. Qualitative Prehension Testing The aim of this sub-section is to ensure that the early movement is captured before an individual may be ready for a seated assessment. No specific positioning of the patient is required, but appropriate positioning of the hand for movement should be ensured. The patient is asked to form three prehension patterns with each hand separately. The requested movement and grasp patterns can be demonstrated by the examiner. The purpose of this testing is to establish which components of the finger-hand-forearm can be actively or passively positioned and directed to allow a grasp function and if the movement is wrist dominant. The intent is to establish whether the participant can perform a limited movement that does or does not include the components to develop an active grasp. The assessor should be looking to isolate, wrist, fingers and thumb. The basic pattern for grasping might be visible although the patient yet can not quite grasp. In the very early stages a patient will require the assessor to support the hand so that the patient can see it. This may require providing the neutral position of the wrist as well. Table 4 defines the three grips to be tested and the associated scoring. Table 4: A. Qualitative Prehension, Instructions and Scoring Qualitative Prehension Task Cylindrical Grasp Neutral wrist position and finger movements performed with gravity

eliminated Lateral Key Pinch Neutral wrist position and finger movements performed with gravity

eliminated Tip to Tip Pinch (thumb and index finger)

Neutral wrist position and finger movements performed with gravity eliminated

Filament Label 3.61 4.31 4.56 6.65 No Response Filament Force in g/F 0.217 2.35 4.19 279.4 No Response Score 4 3 2 1 0

SWM Test Locations

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Scoring 0 - Subject is not able to position the wrist or fingers in any specific pattern for the requested grasp. 1 - Subject is able to move the wrist actively and fingers passively assume the requested prehension pattern (able to begin a grasp using the wrist and no finger movement) 2 - Subject is able to partially or completely move the fingers actively into the requested prehension pattern (combination of wrist movement and intrinsic hand muscle activation) but fails to generate force because the grasp is acquired through passive positioning from the activating the wrist. 3 - Subject is able to actively position the fingers and/or thumb into the requested prehension pattern with normal wrist movement for a grasp, touching the opposite finger(s) or the palm with some noticeable active force. 4 - Subject is able to perform the grasp with normal strength (in a normal shaking hand).

B. Quantitative Prehension Testing The patient is positioned in a sitting position symmetrically in front of a table. Additional support for trunk stability is allowed. This includes for example the use of a belt but also sitting in bed supported by the back rest or using the bed side table to set up the test. · A change in position, concerning the person’s angle to the table, is not allowed during the standardised test administration. · The test is conducted twice, once for the right hand and then once for the left hand. · The stabilisation of the objects/test board, if necessary, is done by the examiner. · The test board is placed parallel to the edge of the table, in front of the patient. Moving the board in a parallel line to the table’s edge is permitted. Turning or rotating of the board is not permitted (see picture). · All other items are placed on the table in front of the patient.

Procedure The required material for the different tasks is placed on the table in front of the patient just prior to the performance of each task. Prior to the first test administration, the patient is allowed to perform each task once as a rehearsal, without being scored. This will allow familiarization with the task and reduce the learning effect. The rehearsal time is limited to 1 minute for each task. The precise administration procedure for each task can be found in the table below.

The examiner times each task. The timing starts at a clear signal “start” by the examiner and ends when the task is fully completed. The material can only be touched or grasped after the “start” signal by the examiner. Table 5 defines the instructions to the examiner and the patient. The initiation of each task is defined by clear activity, such as moving pegs, lifting up coins, manipulating the bottle of water in the hand. To score a 1 at least one part of the task must be done (i.e. lifting up a coin, grasping and/or moving a coin, holding/lifting the bottle). Moving the hand alone is not regarded as "done part of the activity"; neither is placing the hand on the test equipment. The examiner observes task performance focussing on the form of the grasp. The time required for task performance is recorded on the score sheet and the task is scored according to the scoring key in Table 6. Quantitative prehension performance leads to a score with an associated time that is recorded separately. The maximum score for each task is 5 points with a maximal total score of 30 points per hand. To judge the quality of the performance, the examiner must refer to the description of the “expected performance”. This description defines the typical form of grasp used and performance with an unaffected hand (see Table 5). One minute and 15 seconds is allowed for the completion of each task, if the individual is unable to complete the task within 1 minute

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and 15 seconds score accordingly and move on to the next task (Sollerman and Ejeskar, 1995). There is no specific order to the tasks and they appear in order of simplicity (least difficult to more difficult). Dropping of objects: If a patient drops an object and it falls onto the table, still reachable for the patient to retrieve, the task is continued without stopping the clock the drops are counted and the number is entered in the # of drops column. If the object falls onto the floor or the lap of the patient and cannot be reached by the patient, the clock is stopped. The examiner can pick the object up and the task may be repeated. If the drop lands on the floor or lap of the patient again, during the repeated execution, the task is judged as “not conducted" (0 points) and comments are noted. Table 5: Quantitative Prehension, Instructions and Scoring Task and Instructions to Examiner Expected Prehension Pattern for Task Task Instructions for Subject 1. The filled, already opened bottle (0.5L) and the cup are placed onto the table in front of the patient. The task is completed if the water is poured in the cup and cup and bottle are put back down onto the table. The cup is stabilized by the examiner. 50% of task 1 is when the participant has begun to pour the water. Cylindrical grasp 1. Take the bottle and pour the water into the cup,

approx. ¾ full. 2. The two jam jars are placed onto the table in front of the patient. The lids should sit tightly on the jar but should not require much strength to be opened (check before task administration). The task is completed when both lids and jars lay on the table. The jars are stabilized by the examiner. 50% of task 2 is when the participant has removed one lid. Spherical grasp 2. Unscrew the lids of the 2 jars and place them on the

table. 3. The peg board is placed on the table in front of the patient. It does not matter if the pegs are moved from right to left or left to right; the patient can choose his preference. The task is completed when all 9 pegs are placed in the opposite board. The board is stabilized by the examiner or use of dycem. 50% of task 3 is when the participant has inserted 4 pegs. Tip to Tip pinch (thumb and index finger) / Tripod pinch

3. Pull the 9 pegs, one by one, out of the block and place them back into the markings on the opposite side.

4. The test board is placed on the table, parallel to the table’s edge, in front of the patient. The distance from the table’s edge to the test board is not important. The key is put on the table in front of the patient. The turning direction of the key is of no importance. The task is completed when the key was rotated 90°. The board is stabilized by the examiner or use of dycem. 50% of task 4 is when the participant is able to get the key to insertion point. Lateral Key pinch 4. Take the key from the table, insert it in the lock and

turn it 90°. 5. The position of the test board is as described for task no. 4. The coins are placed in a row on the table in front of the patient. The task is completed when all coins are dropped into the slot. The board is stabilized by the examiner or use of dycem. 50% of task 5 is when the participant is able to insert 2 coins Tip to Tip Pinch (thumb and index finger) 5. Pick up the 4 coins, one by one, from the table and

drop them through the slot.

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6. The position of the test board remains the same as described for task no.4 and 5. The 4 nuts are placed in a row onto the table in front of the patient. The task is completed when all nuts are screwed onto the matching screws, the screw’s-end aligned with the nuts. Rotating the test board is not permitted in this task either. The board is stabilized by the examiner or by dycem. 50% of task 6 is when the participant is able to screw two nuts on Tip to Tip pinch (thumb and index finger) and/or Tripod pinch

6. Pick up the 4 nuts, one by one, from the table and screw them onto the matching screws.

Table 6: Scoring for the Quantitative Prehension Scoring (a maximum of 1 minute and 15 seconds is allowed for each task) 0 - the task can not be conducted at all 1 - the task can not be completed, (less than 50% of the task) 2 - the task is not completed, (50% or more of the task) 3 - the task is conducted (completed) using tenodesis or an alternative grasp other than the expected grasp 4 - the task is conducted using the expected grasp with difficulty (lack of smooth movement or difficult slow movement) 5 - the task is conducted without difficulties using the expected grasping pattern and unaffected hand function.

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SCORING SHEETS 1 - Demographics Patient Name Examiner Assessment Number 1 2 3 4 5 6 Date of Assessment DOB Gender Hand Dominance Pre-injury Post-injury Injury Date Injury Type Brief Description

Surgery/Intervention and Date

Comments

2 - Strength - score 0 to 5 as per instructions in each box, then sum for each side

Right Muscles Tested for MMT Left Anterior Deltoid Elbow Flexors Elbow Extensors Wrist Extensors Extensor Digitorum (DIII) Opponens Pollicis Flexor Pollicis Longus Finger Flexors (DIII) Finger Abductors First Dorsal Interossei

/50 Total out of 50 for each side /50

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3 – Sensibility

SWM Threshold Scores

Right Hand Left Hand

3.61 (4) 3.61 (4) 3.61 (4) 4.31 (3) 4.56 (2) 6.65 (1) NR (0)

Score Area 3.61 (4) 3.61 (4) 3.61 (4) 4.31 (3) 4.56 (2) 6.65 (1) NR (0)

Score

1

2

3

Dorsal Total /12 Dorsal Total /12

4

5

6

Palmar Total /12 Palmar Total /12

Dorsal Total+Palmar Total=Total SWM /24 Dorsal Total+Palmar Total=Total SWM /24

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4 - Prehension A - Qualitative Prehension

Right Qualitative Grasps Left Cylindrical Grasp Lateral Key Pinch Tip to Tip Pinch

/12 Total out of 12 /12

B - Quantitative Prehension Right Task/ Instruction

Expected Prehension Left

Time Score Drops Time Score Drops 1. Take the bottle and pour the water

into the cup, approx. ¾ full. Cylindrical grasp

2. Unscrew the 2 lids of the jam jars and put them onto the table. Spherical grasp

3. Pull the 9 pegs, one by one, out of the foam and stick them back into the markings on the opposite side. Tip to Tip pinch

4. Take the key from the table, insert it in the lock and turn it 90°. Lateral Key pinch

5. Pick up the 4 coins, one by one, from the table and put them through the slot. Tip to Tip Pinch

6. Pick up the 4 nuts, one by one, from the table and screw them on the matching screws. Tip to Tip pinch and/or Tripod pinch

Total Score /30 5 – Summary and Total Scores

Right Left STRENGTH-Upper limb (50/50) SWM –DORSAL (12/12) SWM-PALMAR (12/12) PREHENSION – Qualitative (12/12) PREHENSION – Quantitative (30/30) TOTALS /116

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REFERENCES 1. Link C. The Link Hand Function Test for Patients with a Cervical Spinal Cord Injury: An Intra-Rater and Inter-Rater Reliability and Expert Opinion Evaluation Study (2004). Hogeschool van Amsterdam, Institute of Occupational Therapy, The Netherlands; University College-South, School of Occupational Therapy and Physiotherapy, Denmark; Karolinska Institutet Division of Occupational Therapy, Sweden. 2. Kalsi-Ryan S, Beaton D, McIlroy W, Fehlings M, Verrier M. The Development of the Quadriplegia Hand Assessment Tool (Q-HAT) - A Discriminative and Evaluative Approach. Journal of Spinal Cord Medicine. 2004:27(2);164. 3. Marino RJ, Barros T, Biering-Sorensen F, et al. International Standards for Neurological Classification of Spinal Cord Injury. Sixth Edition 2004. 4. Daniels L, Worthingham C. Daniels and Worthingham’s Muscle Testing: Techniques of Manual Examination. Washington: WB Saunders Co. Sixth Edition 1995. 5. Kendall F, McCreary EK, Provance PG. Muscles: Testing and Function, Philadelphia: Williams & Wilkins. Fourth Edition 1993. 6. Mackin E, Callahan A, Skiver T, Schneider L & Osterman A. Hunter-Mackin-Callahan Rehabilitation of the Hand and Upper Extremity. St. Louis, Missouri: Mosby. Second Edition 2002. 7. Sollerman C. & Ejeskar A. Sollerman Hand Function Test: A Standardized Method and its Use in Tetraplegic Patients. Scandinavian Journal of Plastic and Reconstructive Hand Surgery 1995:29;167 – 176.

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Appendix 2

A: Sensibility Questionnaire

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A: Sensibility Questionnaire compiled by Claire Bombardier, University of Toronto, Institute for Work and Health

SENSIBILITY ASSESSMENT WORKSHEET PUPOSE, POPULATION, SETTING

1. Is the purpose clearly specified? What concept or attribute is being measured? What will it be used for (ie. function: description, prognosis, evaluation)? Why is this measurement needed?

2. Is the population clearly specified (ie. Framework)? 3. Is the setting clearly specified (ie. Framework)?

CONTENT VALIDITY

4. Are all relevant domains and exclusions clearly specified?

Are there important omissions? Are there inappropriate inclusions?

5. Is the breakdown of domains and /or categories appropriate, considering the purpose?

Are they mutually exclusive? 6. What was the method of selecting items for inclusions?

FACE VALIDITY

7. Is each element phrased in a suitable way? 8. Are the response categories for each element appropriate? 9. If a global rating is calculated, is the method of aggregation appropriate?

FEASIBILTY

10. Is it easy to understand? Are the items, their scaling and the aggregate score simple?

11. Is it easy to use? Does the data collection sheet conform to basic principles of questionnaire design? Are there instructions and definitions provided? Are procedures standardized?

12. Is is acceptable to the patient and to the observer? 13. Is the format for administration appropriate for your purpose? Does it require

special tests or special skills? 14. Is the administration time suitable?

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Appendix 3

Study Design and Protocol

Figure 1: North American Data Collection

Figure 2: European Data Collection

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Study Design Used to Collect Data: The general methodology for this study was based on establishing psychometric properties. Therefore, a stable sample was targeted and repeated administration of the GRASSP was conducted along with the administration of the comparator measures (SCIM, CUE, ISCSCI). Figures 1 and 2 define the visits, number of GRASSP administrations, raters and the use of data for analysis. Each Figure defines how the study design was similar and different in North America and Europe. Figure 1: North American Data Collection

Figure 1 refers to the method of data collection in the North American centres (n=4) and how the data was used in the analysis.

Visit I

TEST 1

TEST 2

Rater 1

Visit II

TEST 3

SCIM CUE ISCSCI

Inter rater Reliability n=45

Test Retest Reliability n=45

Construct Validity n=45

Rater 1

Rater 2

Rater 2

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Figure 2: European Data Collection

Figure 2 refers to the method of data collection in the European centres (n=3) and how the data was used in the analysis.

Visit I

TEST 1 Rater 1

Visit II

TEST 2

SCIM CUE ISCSCI

Inter rater Reliability n=27

Construct Validity n=27

Rater 2

Rater 1

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Appendix 4

A: Capabilities of Upper Extremity Questionnaire (CUE) B: International Standards of Neurological Classification of Spinal Cord Injury (ISCSCI)

C: Spinal Cord Independence Measure (SCIM)

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A: CUE

The CUE is a 32 item questionnaire developed to assess difficulty in performing certain

activities with the upper extremities. The CUE is a self perceived measure of upper limb

function which incorporates components of reach, grasp and manipulation. The scoring is

based on degree of difficultly in performing tasks which is important in defining functional

limitation (Marino et al., 1998). The questions asked are related to one’s perception of how

difficult a task may be. Psychometric properties of the CUE have been reported as 0.92 for

test retest reliability, tested by Cronbach’s alpha and 0.74 for concurrent validity with the

Functional Independence Measure, tested by Pearson correlation coefficient (Marino et al.,

1998). The CUE was selected as a comparator measure to establish validity and determine

relationships between impairment and self perceived function. Although, the CUE is a

measure of function it incorporates the three aspects of upper limb function (reach, grasp and

manipulation) which make it appropriate for comparisons with the GRASSP and the concepts

that have contribute to it’s design.

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CAPABILITIES OF UPPER EXTREMITY QUESTIONNAIRE

This questionnaire is designed to find out how well you are able to use your arms

and hands. I will ask you about a number of actions which some people with spinal cord

injury have difficulties or limitations performing. Please consider whether, on an average

day, you have difficulties or limitations performing these actions. By this I mean difficulty

doing the action, or trouble doing it as often as you would like or need in order to complete

everyday activities. Consider only the specific part of your arm or hand asked about in each

question. For example, if asked about pulling something with your arm, do not worry about

whether or not you can grab it with your hand.

Answer each question on a scale of 0 to 4, where 4 is the best – you have no

difficulty or limitation doing the action, and 0 is the worst – you are totally limited and can’t

do it at all.

Score

Description

4 No Difficulty

3 Mild Difficulty

2 Moderate Difficulty

1 Severe Difficulty

0 Unable/ Complete difficulty

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CUE 2.1 Unable/

Complete Difficulty

Severe Difficulty

Moderate Difficulty

Mild

Difficulty No

Difficulty

THE FOLLOWING QUESTIONS ARE ABOUT

YOUR ABILITY TO REACH OR LIFT

1. Think about reaching out with your arm to touch something directly in front of you that is at shoulder level:

….how difficult is it to do this using your RIGHT ARM 0 1 2 3 4

...how difficult is it to do this using your LEFT ARM? 0 1 2 3 4

2. Think about raising your arm directly over your head, with your arm straight:

...how difficult is it to do this motion using

your RIGHT ARM?0 1 2 3 4

...how difficult is it to do this motion using

your LEFT ARM?0 1 2 3 4

3. Think about reaching down to touch the floor and sitting back up straight, without hooking with your other arm or using it to pull yourself up:

...how difficult is it to do this with your RIGHT HAND? 0 1 2 3 4

...how difficult is it to do this with your LEFT HAND? 0 1 2 3 4

4. Think about raising a 5-pound object like a heavy blanket over your head using both arms. (Don't worry about whether you could grab it with your hands, just if you could raise something

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that heavy over your head.):

...how difficult is it to do this using BOTH ARMS? 0 1 2 3 4

CUE 2.1 Unable/

Complete Difficulty

Severe Difficulty

Moderate Difficulty

Mild

Difficulty No

Difficulty

THE FOLLOWING QUESTIONS ARE ABOUT YOUR ABILITY TO PULL AND PUSH WITH YOUR

ARMS

5. Think about pulling or sliding (without grasping) a light object such as a can of soda, that is on a table, towards you:

...how difficult is it to do this kind of thing using

your RIGHT ARM?0 1 2 3 4

...how difficult is it to do this kind of thing using

your LEFT ARM?0 1 2 3 4

6. Think about pulling or sliding (without grasping) a heavy object (up to 10 lbs.), that is on a table, towards you:

...how difficult is it to do this kind of thing using

your RIGHT ARM?0 1 2 3 4

...how difficult is it to do this kind of thing using

your LEFT ARM?0 1 2 3 4

7. Think about pushing a light object such as a can of soda on a table, away from you:

...how difficult is it to do this kind of thing using

your RIGHT ARM?0 1 2 3 4

...how difficult is it to do this kind of thing using

your LEFT ARM?0 1 2 3 4

8. Think about pushing a heavy object

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(up to 10 lbs.) on a table, away from you:

...how difficult is it to do this kind of thing using

your RIGHT ARM?0 1 2 3 4

...how difficult is it to do this kind of thing using

your LEFT ARM?0 1 2 3 4

9. Think about pushing down with both arms into your chair enough to lift your buttocks (both sides) off the seat (do a push-up weight shift):

...how difficult is it to do this? 0 1 2 3 4

CUE 2.1 Unable/

Complete Difficulty

Severe Difficulty

Moderate Difficulty

Mild

Difficulty No

Difficulty

THE FOLLOWING QUESTIONS ARE ABOUT MOVING AND

POSITIONING YOUR ARM AND WRIST

10. With your hand on your lap palm down, think about curling your wrist upwards, keeping your arm on your lap:

...how difficult is it to do this motion using

your RIGHT HAND?0 1 2 3 4

...how difficult is it to do this motion using

your LEFT HAND?0 1 2 3 4

11. Think about turning your hand over - from your palm facing up to facing the floor, keeping your elbow bent at your side (the arm motion someone would make when turning a doorknob or a dial):

...how difficult is it to do this motion using

your RIGHT ARM?0 1 2 3 4

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...how difficult is it to do this motion using

your LEFT ARM?0 1 2 3 4

THE FOLLOWING QUESTIONS ARE ABOUT USING YOUR

HANDS AND FINGERS

12. Think about grasping and holding an object like a hammer with your hand:

...how difficult is it to do this kind of thing using

your RIGHT HAND?0 1 2 3 4

...how difficult is it to do this kind of thing using

your LEFT HAND?0 1 2 3 4

13. Think about picking up a small object such as a paper clip or the cap of a tube of toothpaste with the tips of your thumb and first two fingers:

...how difficult is it to do this kind of thing using

your RIGHT HAND?0 1 2 3 4

...how difficult is it to do this kind of thing using

your LEFT HAND?0 1 2 3 4

CUE 2.1 Unable/

Complete Difficulty

Severe Difficulty

Moderate Difficulty

Mild

Difficulty No

Difficulty

14. Think about pinching and holding an object between your thumb and the side of your index finger, such as holding a key:

...how difficult is it to do this kind of thing using

your RIGHT HAND?0 1 2 3 4

...how difficult is it to do this kind of thing using

your LEFT HAND?0 1 2 3 4

15. Think about grasping a large object like the lid of a 2 pound jar of

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mayonnaise with the tips of the fingers hard enough to pick the jar up or open the lid:

...how difficult is it to do this kind of thing using

your RIGHT HAND?0 1 2 3 4

...how difficult is it to do this kind of thing using

your LEFT HAND?0 1 2 3 4

16. Think about using your fingers to manipulate objects, such as holding a coin and turning it over and over with your fingers:

...how difficult is it to do this kind of thing using

your RIGHT HAND?0 1 2 3 4

...how difficult is it to do this kind of thing using

your LEFT HAND?0 1 2 3 4

17. Think about pressing something with the tip of your index finger (not knuckle) such as dialing a touch-tone phone or ringing a doorbell:

...how difficult is it to do this kind of thing using

your RIGHT HAND?0 1 2 3 4

...how difficult is it to do this kind of thing using

your LEFT HAND?0 1 2 3 4

CUE v2.1 January, 2006

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B: ISCSCI

The ISCSCI renders a sensory and motor level for each side which is based on the most

normal caudal spinal cord level that is represented by the dermatomes and myotomes tested.

A sensory or motor neurological level is derived when the most caudal side is used to express

the spinal level. A SCI can also be classified according to the ASIA impairment scale as A, B

C, D or E. Also, four different syndromes for SCI can also be defined. And finally a zone of

partial preservation is derived from the partial sensory and motor integrity below the

assigned ISCSCI levels. Reliability is 35% to 93% consistent among raters across sensory

and motor testing (Priebe and Waring, 1991). The ISCSCI was selected for use in the study

to define the sample according to an international classification method and to define the

severity of injury for individuals involved in the study. The ISCSCI is the most widely used

measure to define sensory and motor levels in SCI, therefore, considered by some to be a

“gold standard” in the discrimination of SCI. The ISCSCI was therefore, used as a

comparator to establish validity with GRASSP.

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C: SCIM

The SCIM is a global measure of function specific for individuals with SCI (Catz et al.,

2004), used to define the function and independence of the sample in this study. The SCIM is

a scale that has been specifically developed to evaluate the functional outcomes of patients

with traumatic and non-traumatic SCI. The SCIM assesses function in three core areas: 1)

Self-care, which includes feeding, bathing, dressing and grooming, and is scored between a

range of 0 to 20; 2) Respiration and sphincter management are scored between a range of 0 to

40; and lastly 3) Mobility, also scored between a range of 0 to 40 (Catz et al., 2007). Inter

rater reliability is above 0.8 when assessed by agreement statistics for most SCIM items, and

ICC for the total score is 0.94. Concurrent validity of the SCIM with the FIM is 0.79

(Itzkovich et al., 2007). In this analysis the SCIM self care subscale (SCIM-SS) was used as

one of the representations of upper limb function. The SCIM-SS includes items solely related

to the use of the upper limb; therefore, comparisons between the GRASSP subtests are made

with the SCIM-SS, rather than the total SCIM score. Subscales of the SCIM are reliable and

useful quantitative representations of the specific constructs of independence in SCI (Catz et

al., 2007). Some researchers have found the subscales to be more specific for targeted

analyses, such as: the mobility subscale for comparison with other measures of walking and

the selfcare subscale for comparison with other measures of the upper limb (Rudhe and van

Hedel, 2009; van Hedel, 2009).

Function for individuals with tetraplegia is often considered to represent overall

global function. Therefore, the SCIM was used as a comparator between impairment and

function.

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Spinal Cord Independence Measure

Patient ID Number: _______ Examiner: _________________________ Date: __________ Enter the score for each function in the adjacent square Self-Care 1. Feeding (cutting, opening containers, bringing food to mouth, holding cup with fluid) 0. Needs parenteral, gastrostomy or fully assisted oral feeding 1. Needs partial assistance for eating and/or drinking, or for wearing adaptive devices 2. Eats independently; needs adaptive devices or assistance only for cutting food and/or pouring and/or opening containers 3. Eats and drinks independently; does not require assistance or adaptive devices 2. Bathing (soaping, manipulating water tap, washing). A-upper body; B-lower body A. 0. Requires total assistance 1. Requires partial assistance 2. Washes independently with adaptive devices or in a specific setting 3. Washes independently; does not require adaptive devices or a specific setting B. 0. Requires total assistance 1. Requires partial assistance 2. Washes independently with adaptive devices or in a specific setting 3. Washes independently; does not require adaptive devices or a specific setting 3. Dressing (preparing clothes, dressing, undressing). A-upper body; B-lower body A. 0. Requires total assistance 1. Requires partial assistance with clothes without buttons, zippers or laces (cwobzl) 2. Independent with cwobzl; requires adaptive devices and/or in a specific setting (adss) 3. Independent with cwobzl; does not require adss; requires assistance or adss only for bzl 4. Dresses (any cloth) independently; does not require adaptive devices or specific setting B. 0. Requires total assistance 1. Requires partial assistance with clothes without buttons, zippers or laces (cwobzl) 2. Independent with cwobzl; requires adaptive devices and/or in a specific setting (adss) 3. Independent with cwobzl; does not require adss; requires assistance or adss only for bzl 4. Dresses (any cloth) independently; does not require adaptive devices or specific setting 4. Grooming (washing hands and face, brushing teeth, combing hair, shaving, applying makeup) 0. Requires total assistance 1. Requires partial assistance 2. Grooms independently with adaptive devices 3. Grooms independently without adaptive devices S u b t o t a l (0 - 20) Respiration and Sphincter Management 5. Respiration 0. Requires tracheal tube (TT) and permanent or intermittent assisted ventilation (IAV) 2. Breathes independently TT; requires oxygen, much assistance in coughing or TT management 4. Breathes independently with TT; requires little assistance in coughing and TT management 6. Breathes independently without TT; requires oxygen, much assistance in coughing, a mask (e.g. peep) or IAV (bipap) 8. Breathes independently without TT; requires little assistance or stimulation for coughing 10. Breathes independently without assistance or device 6. Sphincter Management D Bladder 0. Indwelling catheter 3. Residual urine volume (RUV) > 100 cc; no regular catheterization or assisted intermittent catheterization 6. RUV < 100 cc or intermittent self-catheterization; needs assistance for applying drainage instrument 9. Intermittent self-catheterization; uses external drainage instrument; does not need assistance for applying 11. Intermittent self-catheterization; continent between catheterizations; does not use external drainage instrument 13. RUV < 100cc; needs only external urine drainage; no assistance is required for drainage 15. RUV < 100cc; continent; does not use external drainage instrument 7. Sphincter Management D Bowel 0. Irregular timing or very low frequency (less than once in 3 days) of bowel movements 5. Regular timing, but requires assistance (e.g., for applying suppository); rare accidents

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(less than twice a month) 8. Regular bowel movements, without assistance; rare accidents (less than twice a month) 10. Regular bowel movements, without assistance; no accidents 8. Use of Toilet (perineal hygiene, clothes adjustment before after, use of napkins or diapers) 0. Requires total assistance 1. Requires partial assistance; does not clean self 2. Requires partial assistance; cleans self independently 4. Uses toilet independently in all tasks but needs adaptive devices or special setting (e.g., bars) 5. Uses toilet independently; does not require adaptive devices or special setting (e.g., bars)

S u b t o t a l (0 - 40) Mobility (room and toilet) 9. Mobility in Bed and Action to Prevent Pressure Sores 0. Needs assistance in all activities; turning upper body in bed, turning lower body in bed, sitting up in bed, doing push-ups in wheelchair, with or without adaptive devices, but not with electric aids 2. Performs one the activities without assistance 4. Performs two or three of the activities without assistance 6. Performs all the bed mobility and pressure release activities 10. Transfers: bed-wheelchair (locking wheelchair, lifting footrests, removing and adjusting arm rests, transferring, lifting feet) 0. Requires total assistance 1. Needs partial assistance and/or supervision and/or adaptive devices (e.g., sliding board) 2. Independent (or does not require wheelchair) 11. Transfers: wheelchair-toilet-tub (if uses toilet wheelchair; transfers to and from; if uses regular wheelchair; locking wheelchair, lifting footrests, removing and adjusting armrests, transferring, lifting feet) 0. Requires total assistance 1. Needs partial assistance and/or supervision, and/or adaptive devices (e.g., grab-bars) 2. Independent (or does not require wheelchair) Mobility (indoors and outdoors) 12. Mobility Indoors 0. Requires total assistance 1. Needs electric wheelchair or partial assistance to operate manual wheelchair 2. Moves independently in manual wheelchair 3. Requires supervision while walking (with or without devices) 4. Walks with a walking frame or crutches (swing) 5. Walks with crutches or two canes (reciprocal walking) 6. Walks with one cane 7. Needs leg orthosis only 8. Walks without aids 13. Mobility for Moderate Distances (10 - 100 metres) 0. Requires total assistance 1. Needs electric wheelchair or partial assistance to operate manual wheelchair 2. Moves independently in manual wheelchair 3. Requires supervision while walking (with or without devices) 4. Walks with a walking frame or crutches (swing) 5. Walks with crutches or two canes (reciprocal walking) 6. Walks with one cane 7. Needs leg orthosis only 8. Walks without aids 14. Mobility Outdoors (more than 100 meters) 0. Requires total assistance 1. Needs electric wheelchair or partial assistance to operate manual wheelchair 2. Moves independently in manual wheelchair 3. Requires supervision while walking (with or without devices) 4. Walks with a walking frame or crutches (swing) 5. Walks with crutches or two canes (reciprocal walking) 6. Walks with one cane 7. Needs leg orthosis only 8. Walks without aids 15. Stair Management 0. Unable to climb or descend stairs 1. Climbs and descends at least 3 steps with support or supervision of another person 2. Climbs and descends at least 3 steps with support of handrail and/or crutch or cane 3. Climbs and descends at least 3 steps without any support or supervision

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16. Transfers: wheelchair-car (approaching car, locking wheelchair, removing arm and foot rests, transferring to and from car, bringing wheelchair into and out of car) 0. Requires total assistance 1. Needs partial assistance and/or supervision and/or adaptive devices 2. Transfers independent; does not require adaptive devices (or does not require wheelchair) 17. Transfers: ground-wheelchair 0. Requires assistance 1. Transfers independent with or without adaptive devices (or does not require wheelchair)

S u b t o t a l (0± 40)

TOTAL SCIM SCORE (0± 100)

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Appendix 5 A: Guttman Scaling Procedure

B: Matrices used to rank-order all items within subtests

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Guttman Scaling: Guttman scaling is a procedure used to determine whether a set of items can be rank-ordered on a unidimensional scale. Guttman scaling is also sometimes known as cumulative scaling or scalogram analysis. The purpose of Guttman scaling is to establish a one-dimensional continuum for a concept you wish to measure (Guttman 1944; Guttman 1950, Trochim, 2010). In the case of the items within subtests of GRASSP the order was defined by sensory and motor spinal cord levels moving rostral to caudal. The steps that were conducted to perform the manual Guttman scaling are as follow:

1. First the items for each subtest are reorganized to best represent spinal nerve root order example moving left to right items would be ordered to represent C6, C7 and C8 and so on and so forth. In the case of prehension where myotomes and dermatomes are not so clearly defined, innervation of muscles for specified grips were used to determine order of items.

2. Each set of ratings for all items would then be ordered according to responses, more and greater responses to each item were moved towards the bottom of the list and fewer and lower responses moved to the top. Main point is to look for a cumulative order, for example that if item #2 is scored at a 3 that item #1 would be scored at a 3 or more and so and so forth for all items.

3. In the strength scores, 0 and 1 were collapsed and 4 and 5 were collapsed. In Prehension performance 4 and 5 were collapsed.

4. Any set of ratings that did not show a cumulative item response pattern were placed in the exceptions and were not considered to show a cumulative predictive item response pattern.

5. Since a large part of the sample did show a cumulative predictive item response pattern it was concluded that items could be summated for subtest total scores.

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Guttman Matrices of Dorsal Sensation before and after ordering: Item Item

Table 1 illustrates the Dorsal Sensation, items and total scores for the whole sample. C6 represents Test Location 1, C7 represents Test Location 2, and C8 represents Test Location 3. The table on the left side presents the data as it was entered and the table on the right side presents the data ordered by cumulative predictability of the item scores, in descending order of less impairment. The bottom shaded group of data is the individuals with unpredictable item responses.

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Guttman Matrices of Palmar Sensation before and after ordering: Item Item

Table 2 illustrates the Palmar Sensation items and total scores for the whole sample. C6 represents Test Location 4, C7 represents Test Location 5 and C8 represents Test Location 6. The table on the left side presents the data as it was entered and the table on the right side presents the data ordered by cumulative predictability of the item scores, in descending order of less impairment. The shaded group of data is the individuals with unpredictable item responses.

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Guttman Matrices of Strength before and after ordering: Item Item

Table 3 illustrates the Strength items and total scores for the whole sample. M1 represents Anterior Deltoid (C5), M2 represents Biceps (C5), M3 represents Triceps (C7), M4 represents Wrist Extensors (C6), M5 represents Extensor Digitorum (C8), M6 represents Opponens Policis (C7), M7 represents Finger Flexors (C8), M9 represents Finger Abductor (DV) (T1) and M10 represents Dorsal Interossei (T1). Items are ordered according to myotomal order. The table on the left side presents the data entered and the table on the right side presents the sample ordered by cumulative predictability of the item scores, in descending order of less impairment. The shaded group of data is individuals with unpredictable item responses.

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Guttman Matrices of Prehension Ability before and after ordering: Item Item

Table 4 illustrates the Prehension Ability items and total scores ordered according to muscle innervation which represent myotomal order. Grasp 1 represents cylindrical grasp, Grasp 2 represents lateral key pinch and Grasp 3 represents tip to tip pinch. The table on the left side presents the data as entered and the table on the right side presents the sample ordered by cumulative predictability of the item scores, in descending order of less impairment. The shaded group of the sample are the individuals with unpredictable item responses.

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Guttman Matrices of Prehension Performance before and after ordering: Item Item

Table 5 illustrates the Prehension Performance items ordered according to muscle innervation that represents myotomal order. Task 1 through 6 represent the tasks defined in the GRASSP. The table on the left side presents the data as entered and the table on the right side presents the sample ordered by cumulative predictability of the item scores, in descending order of less impairment. The shaded group of the sample are the individuals with unpredictable item response.