Note: this is the final draft of the manuscript

Burridge JH, Lee A, Turk R, Stokes M, Whitall J, Vaidyanathan R, Clatworthy P, Hughes AM, Meagher C, Franco E, Yardley L

Tele-health, wearable sensors and the Internet. Will they improve stroke outcomes through increased intensity of therapy, motivation and adherence to rehabilitation programs?

Accepted January 15th 2017 for publication inJournal of Neurologic Physiotherapy 2017

Abstract

Background and Purpose

Stroke, predominantly a condition of older age, is a major cause of acquired disability in the

global population and puts an increasing burden on healthcare resources. Clear evidence

for the importance of intensity of therapy in optimizing functional outcomes is founded in

animal models, supported by neuroimaging and behavioral research, and strengthened by

recent meta-analyses from multiple clinical trials. However, providing intensive therapy

using conventional treatment paradigms is expensive and sometimes not feasible due to

patients’ environmental factors. This paper addresses the need for cost-effective increased

intensity of practice and suggests potential benefits of telehealth (TH) as an innovative

model of care in physical therapy.

Summary of Key Points

We provide an overview of TH and present evidence that a web-supported program used in

conjunction with Constraint Induced Therapy (CIT), can increase intensity and adherence to

1

a rehabilitation regimen. The design and feasibility testing of this web-based program,

‘LifeCIT’ is presented. We describe how wearable sensors can monitor activity and provide

feedback to patients and therapists. The methodology for the development of a wearable

device with embedded inertial measurement units and mechanomyography sensors,

algorithms to classify functional movement, and a graphical user interface to present

meaningful data to patients to support a home exercise program is explained.

Recommendations for Clinical Practice

We propose that wearable sensor technologies and TH programs have the potential to

provide cost-effective, intensive, home-based stroke rehabilitation.

Introduction

This special interest report presents an overview of telehealth (TH) and gives two examples

of technology-supported therapies. The first uses TH, the second has the potential for

incorporating TH applications. Both address the need for cost-effective increased intensity

of practice i.e. without increased therapist/patient contact time.

Worldwide, recent research estimates annual incidence of first stroke to be 16.9 million,

with a prevalence of 33 million.1 Approximately 70% of people experience impairment of

arm function after stroke, and an estimated 40% are left with a persistent reduction in arm

function.1 A large meta-analysis identified that scheduled therapy time was the main

predictive factor for improved function irrespective of time since stroke.3 Technologies,

2

especially those incorporating TH may be an effective way of increasing therapy time

without increasing therapists’ time.

Telehealth is the use of a variety of telecommunication technologies to provide health care

remotely and is defined in different ways. The physical therapy profession defines TH as the

use of secure electronic communications to provide and deliver a host of health-related

information and health care services; including, but not limited to, physical therapy-related

information and services for patients and clients.4 Speech therapists in United States define

TH applications as telepractice.5 Internationally, physiotherapists and occupational

therapists utilize telerehabilitation6 as the common term for TH applications. In practice,

telecommunication technologies that deliver real-time audio and video conferencing

between providers and patients is described as synchronous TH. Other TH applications

include secure electronic transmission of clinical information and medical data, described as

asynchronous, store-and-forward TH. Remote patient monitoring in TH has emerged

alongside the advent of biotechnology and virtual environments. Synchronous TH

applications are now evident in randomized trials for cardiac rehabilitation,6 total joint knee

rehabilitation,7,8 and stroke care.9 These physical therapy-based TH randomized trials have

demonstrated feasibility and non-inferior clinical outcomes compared to usual care.7,8 One

clinical trial reported reduced cost for in-home TH application compared to usual care when

patients resided over 30 Km from the health care center 10.

3

Home-based technologies, especially those supported by TH, could provide cost-effective

intensive therapy by reducing the ratio between therapist’s time and total therapy time, but

has not yet been demonstrated in large clinical trials.

Translation of TH into clinical practice requires evidence of both effectiveness and cost-

savings, which is not yet available, as well as an understanding of how it could be used to

address challenges in rehabilitation. Motivation maybe one of the most important factors in

adherence to therapy and therefore needs to be considered in technology design and

implementation. Use of technologies requires a change in practice and a change in

expectation of patients. Key barriers that both providers and patients face in the translation

of assistive technologies (ATs) into clinical practice have been identified as lack of

knowledge, education, awareness and access.11 Each need to be addressed for effective

translation and dissemination. There is also a need to change expectations of patients.

Possibly one of the most important benefits of TH is a shift from dependence to

independence, incorporating the concept of self-management and responsibility for one’s

own recovery and well-being. Self-management of health is increasingly seen as important

for all of us, and may be critical to improved health in the 21st Century 12. This change in

approach is realized through advances in telecommunication technology such as; audio and

video conferencing and remote monitoring of health, supported by the ability to transmit

large amounts of data securely. The use of Inertial Measurement Units (IMUs) to monitor

activity, has become common in devices such as mobile phones and activity monitors. This

commercial technology provides an opportunity, with more sophisticated signal processing,

to generate clinically meaningful information about amount and quality of movement and

4

could support self-management by providing patients with information to guide and

encourage activity.

Telehealth applications are expanding with trends in access to healthcare towards user

preference, managing acute and chronic conditions at the right time and place, migration of

care from hospitals and clinics to patient’s homes and the use of mobile devices.13 As future

TH applications are introduced to clinical practice, physical therapists have an opportunity

and obligation to provide the best care based on sound research and strong evidence.

Key points

To illustrate how technologies can be used in stroke rehabilitation, we present two

examples. One technology (LifeCIT) has been developed and undergone clinical feasibility

testing, while the second (M-MARK) is in the early stages of development. LifeCIT is a web-

based support program for people with stroke using Constraint Induced Therapy (CIT) at

home. A meta-analysis has provided evidence that CIT is more effective than other dose

matched interventions.14 Studies of CIT have shown positive outcomes on motor function in

the early stages post-stroke and functional gains in chronic stroke.15,16,17

Despite the benefits, CIT was reported by healthcare professionals as less likely to be

prescribed than other technologies such as Functional Electrical Stimulation or Virtual

Reality (such as the Nintendo Wii) and the standard CIT protocol has not necessarily

changed clinical practice because of the demand on professional resources.11,15 Protocols

for delivery of CIT in the home-based setting, in North Germany, with minimal therapist

5

contact time, have recently been published.16 Patients, however, described lack of

motivation when a therapist was not present as a key barrier to adherence. 16 One large-

scale 2-arm randomised controlled trial (n=156) in which participants were asked to

exercise for 2 hours/day, 5-days a week for 4 week (total 40 hours), without therapist

supervision, reported an average of only 27 hours over the 4-week intervention period.16

Given the strong evidence for the effectiveness of CIT, 17 the study concluded that future

studies should explore whether the effect of home CIT could be increased through an

intensified support in daily practice, for example via electronic devices with videos or apps.16

Responding to this conclusion, a web-supported program of CIT for people with upper limb

disability after stroke (LifeCIT) was designed and tested for feasibility and safety. LifeCIT

was co-designed with patients, carers and healthcare professionals using the ‘Person-Based

Approach’ to intervention development.18 Qualitative ‘think aloud’ studies were conducted

with 4 participants who were >6-months post stroke and 13 who were < 6-months post

stroke (with their carer when appropriate). Each participant tested the program, including

mock-ups of the web-pages, during development. Therapist input was gained through six

focus groups, each with between two and six therapists. An inductive, iterative process was

used to finalize the design of LifeCIT. Factors that were found to be important in making

the system usable by patients (who were often not experienced users of computers) were:

a) avoiding scrolling, i.e. the whole web-page was visible on the screen; b) given an option

to return to the home page on every page, i.e. never more than one-click away from the

home page; c) minimal text, which always used simple language and using images wherever

possible. Specially designed computer games, which were simpler than commercially

6

available ones, were also found to be important. Once LifeCIT was developed, a two-arm,

parallel-group, randomized study was conducted with chronic and sub-acute post-stroke

patients to assess the feasibility of using the program in practice. The trial was conducted in

accordance with the Declaration of Helsinki, and was approved by the South West England

National Health Service Research Ethics Committee (11/SC/0286).

LifeCIT aimed to increase adherence to constraint mitt (C-Mitt) wear, for up to 6 hours a day

and a self-directed program of exercises and activities of daily living (ADLs). The C-Mitt

(Figure 1) resembled an oven glove, but incorporated a moulded plastic liner in the palm to

prevent dextrous use of the unaffected hand and fingers, while allowing sufficient grip to

hold a walking aid. Participants used the website via a computer or computer tablet. The

first time patients logged on they were asked to complete a self-assessment of upper limb

function, based on the Motor Activity Log (MAL)21. The answers they gave were used by the

software to automatically offer appropriate level activities. The website then offered

information about CIT and how to get the best out of using LifeCIT. Users were advised to

log-in to the website in the morning and evening of each day. In the morning, they were

asked to set themselves targets for C-Mitt wear time and time spent on exercises and ADL

activities. From the website, they could choose: computer-based games that involved arm

and hand activity; exercises, from a menu based on the Graded Arm Supplementary

Program (GRASP),19 and ADLs that were relevant to them and achievable. After setting

targets and chosen activities, they could leave the schedule on the screen, print it out or

send it as a text message. When they logged on in the evening, they were asked to report

their level of achievement in terms of C-Mitt wear and exercises / ADLs. Setting personal

7

goals and then reporting achievement of them was thought by patients, carers and

therapists to be motivating and have a positive effect on adherence. Users were also able to

see a graph of their C-Mitt and activity time for each day and, if they failed to achieve their

goals, advice was given in the form of messages on the website on how they could improve.

Information recorded on the website was available to their therapist and any other family

members or friends to whom they chose to allow access. A website messaging facility

allowed therapists, and selected family and friends to communicate with the user and give

encouragement in a secured password-protected internet connection. Apart from an initial

set-up visit, there was no face-to-face contact with a therapist.

Participants

The main inclusion criteria were: stroke affecting the upper limb, safe to use the C-Mitt at

home (defined as able to walk safely with or without an aid, or a none-walker); have a

minimum of 10 active wrist extension and be able to complete a grasp task from the Wolf

Motor Function Test (WMFT). Participants were 18 or over (with no upper age limit) and

had been discharged from hospital to their own homes. There was no limit on time post

stroke. People with severe shoulder pain and / or communication problems were excluded,

but other impairments such as visual neglect was not an exclusion criterion. Participants

were recruited from six NHS Hospital Trusts in the South of England.

Intervention

8

Participants in the LifeCIT group were given the correct size of C-Mitt and shown how to put

it on (no special skill was needed to do this). LifeCIT requires no formal training. Once

shown how to access the web-site and log-on, all instructions and guidance on using the

system are embedded in the pages. Participants were given access to the web-based

program for 21 days and advised to use the system 5 days per week (15 days). The control

group continued to receive standard care.

Measures

Feasibility was assessed by retention and adherence (duration of C-Mitt wear, activities and

use of the website). Use of website was recorded automatically when participants were

logged-on, which included the self-assessment, goal setting, selection of tasks and practicing

of computer-based exercises and games. Daily targets, self-reported activity and

achievements, and time spent on the website was automatically recorded on the website

each day.

Main outcome measures were: The Wolf Motor Function Test (WFMT)20 and the Motor

Activity Log (MAL)21 (a self-assessment tool that measures about amount and quality of use

of the affected upper limb) at baseline, 1 week after completing the intervention, and 6-

months post-randomization. Interviews were conducted with participants in the LifeCIT

group at the end of the treatment period to gain an understanding of their views and

experience of using the website and wearing the C-Mitt. To overcome the problem of un-

blinding of assessors and inter-rater variability, all assessments (except the MAL) were

video-recorded and re-scored independently at a later date by a trained assessor who was

9

unaware either of the participant’s group allocation or whether the assessment was

baseline, end of treatment or follow-up.22 Safety was measured by documentation of

adverse and serious adverse events and reported following standard procedures for each

rehabilitation center. The economic impact (use of health and social care) of the LifeCIT

intervention compared with usual care was examined using the Client Service Receipt

Inventory (CSRI).23

Brief summary of the findings

Eighty-three people with stroke were sequentially screened, three declined because they

were unable to use a computer. Nineteen, who satisfied the selection criteria and gave

informed consent, were recruited: 11 were randomly allocated to the intervention group

and 8 to the control group. There were no adverse or serious adverse events related to the

intervention. The intervention was well accepted and improvement in upper limb function

was observed. In addition, positive effects on self-efficacy, confidence to use the affected

arm and body image were reported in post-intervention, independently conducted

interviews. Mean C-Mitt wear time was 4.8 (SD 2.6) hours /day and activities were

performed for an average of 3.2 (SD 1.7) hours each day. Participants reported wearing the

C-Mitt and using the website on 13.6 (SD 2.1) days out of a possible 15 days. Minimum

Clinically Important between group differences (MCID) were found in all measures at the

end the treatment period and in the WMFT (FAS) at 6-months. MAL: 10% (i.e. 0.5),24 WMFT

(FAS) 0.2-0.4.25 It was beyond the scope of this feasibility study to provide statistical

evidence for either effectiveness or cost-effectiveness.

10

The second technology, that we use to illustrate the potential for TH application is M-MARK

(Mechanical Muscle Activity with Real-time Kinematics). M-MARK is under development.

The M-MARK project aims to develop and test a garment with embedded sensors to

support home-based upper limb stroke rehabilitation.

M-MARK (Figure 2) is a low-cost wearable wireless device that patients can use

independently at home while practicing standardized everyday activities, such as, reaching,

grasping and manipulating objects and practicing exercises to regain upper limb function.

M-MARK incorporates feedback, presented on a computer tablet, as visualizations, of

movement and muscle activity (generated by data from the sensors), for example as an

avatar. The avatar represents both their affected and unaffected side, and illustrates

compensatory movements such as excessive trunk movement when reaching forwards. It

will also provide audio feedback during the performance of activities to confirm normal

movement strategies and muscle activation times. The same device, but with different

software and interfaces, aims to satisfy the need of therapists for a simple system to

diagnose specific movement problems (e.g. reduced range of movement or abnormal

muscle synergies), to inform clinical decision-making, monitor progress and thus increase

efficiency and effectiveness of therapy.

M-MARK comprises Inertial Measurement Units (IMU) and mechanomyography (MMG)

sensors embedded in a stretchy garment with integral wiring and a central rechargeable

power supply. Data are transmitted wirelessly to a computer tablet. Commercially available

inertial measurement units (IMU) can accurately record movement yet are rarely used

11

clinically. One reason may be that although they provide data on amount of arm use, they

currently do not provide information about quality of movement. Electromyography (EMG)

to record muscle activity has been available for many years but is rarely used by therapists.

An alternative to EMG is MMG.26 MMG measures muscle activity using a sensor to detect

vibration. MMG is easier to use than EMG because it does not require electrical skin contact

or precise positioning and has the added advantage that the amplitude of the signal

corresponds to muscle force rather than the electrical discharge at the neuromuscular

junction. MMG does, however, demand advanced signal processing techniques to deal with

artifacts. By integrating IMU and MMG data, measures of quality and quantity of movement

will be generated. A laboratory-tested device that combines an IMU with an MMG sensor

has been designed (patent filed), and built. Novel signal processing techniques27,28 have

isolated physiological acoustic signals that have been demonstrated to reduce problems of

vibration artifacts and generate useful information on mechanical muscle activity. Together

the sensors provide unique, synergistic data describing functional use of the arm,

generating real-time qualitative and quantitative information on mechanical muscle activity

and movement. Data and guidance on performance of activities (patients) and assessments

(therapists) are presented on a computer tablet in appropriate forms. Current algorithms

will be extended and new algorithms written to capture features of movement that we

expect to be useful to patients and therapists. The project will focus on ~10 functional tasks

performed at different levels, for example reaching to grasp a mug on a table, from a low

shelf or above the head, and from these tasks, generate data on, for example: deviation

from expected direction, speed, smoothness and range of movement; movement synergies

12

such as shoulder abduction and trunk movement when reaching forward, and muscle

activity such as: timing (expected onset times and inappropriate activation, indicating

spasticity), strength and co-contraction.

The design of M-MARK uses a similar stakeholder engagement process to LifeCIT,

incorporating focus groups with therapists and interviews with patients and caregivers. A

first prototype garment with embedded sensors, software to generate metrics and a

Graphical User Interface (GUI) to present data in a meaningful and engaging way has now

been built for patients and therapists to test in a pilot study. The stakeholder views will be

incorporated in the final system.

The system has undergone validity and reliability testing of the devices alone and the

complete system. Regulatory and safety standards are being strictly followed and the M-

MARK will be CE marked for commercialization and clinical use in Europe. During the final

six-months of the project a series of case studies will be conducted in the laboratory, to

ensure that the system is working well technically, and that patients are able to use it

correctly and effectively. Any necessary minor changes will then be made before conducting

a feasibility study with ten patients in their own homes, and with their therapists.

Although not included in the current project, the team is working with TH companies to

design a simple web-based system to enable therapists to monitor patients remotely,

access data generated by M-MARK and to link patients not only with their therapists but

also with their family members, friends and even other people with stroke.

13

A business plan is being prepared, which incorporates potential health economic benefits,

market analysis and routes to market. As well as publication of the findings, information

about the M-MARK and the results of the study will be disseminated among potential users,

service providers and policy-makers, prior to conducting a clinical trial.

Discussion and Conclusion

We have provided an overview and given two examples of technologies that can exploit the

benefits of TH to augment conventional therapy. There are three drivers for TH in stroke

rehabilitation. The first is enabling patients to experience greater intensity of therapy, the

second to provide intensity without additional therapist time and therefore with minimal

additional costs and the third is to make rehabilitation more accessible to patients. Current

and recent developments in wearable sensors, signal processing and Information

Technology (IT) have created an environment that is ripe for application to stroke

rehabilitation. We discuss these three drivers in the context of the technologies we have

described and the current evidence.

Comparing LifeCIT with a recent study of Home-based CIT (HOMECIMT) in which TH was not

provided,16 highlighted differences in adherence. Participants using LifeCIT wore the C-Mitt

for an average of 4.8 hours / day, whereas in the HOMECIMT study, time wearing the glove

(the equivalent of the C-Mitt), which 65% of participants recorded in their diaries, reported

a total of between 20-80 hours over a four-week period. Assuming use on 5 days/week, this

equates with between 1 and 4 hours /day). LifeCIT participants spent an average of 3.2

hours/day practicing activities whereas HOMECIMT recorded 27 hours over the four-week

14

period. Again, assuming use on 5 days/ week, this equates with 1.4 hours/day. These

differences in intensity cannot be unequivocally attributed to the web-based support

component, but nevertheless LifeCIT participants exercised and wore the constraint for

longer.

To determine the cost-benefit of using TH and technologies requires evidence generated

from adequately-powered clinical trials. The studies described have demonstrated

feasibility and potential; they have applied the basic principle and existing evidence3, that

more intensive therapy, provided in people’s own homes without additional therapist time

is likely to accrue cost benefits provided outcomes are the same or better.

The results of the LifeCIT study cannot be generalised to everyone with reduced upper limb

function following stroke because all those who took part had sufficient function to be able

to use the C-Mitt. The web pages have therefore been adapted to enable people with

stroke who have less upper limb function, for whom using a C-Mitt would not be

appropriate or safe. Using the same screening questions, taken from the MAL, lower

functioning patients are guided towards less demanding exercises, tasks and goals with no

reference to wearing the C-Mitt. Using a computer did not seem to be problem for these

patients, but the webpages needed to be easy to use.

M-MARK was conceived to satisfy the demand by therapists for a system to support

patients undergoing stroke rehabilitation in their own homes, specifically the need for

feedback on quality movement and amount of practice, as well as therapists’ need for

objective measures of performance. M-MARK has yet to be evaluated with patients

15

therefore there is no evidence that the concept will be beneficial or cost-effective. To

include a TH component would be a simple add-on and enable therapists to monitor

patients’ progress remotely from various environments.

Traditional stroke care and rehabilitation is expensive. However, evidence is emerging for

telestroke care with cost savings.29 Furthermore, telerehabilitation has demonstrated cost

savings for total knee arthroplasty in several trials.30,31 Therefore, we propose that it is time

to use TH more widely in physical therapy so that cost-effectiveness can be audited.

Recommendations for Clinical Practice

The status of TH presents possibilities for future clinical practice in physical therapy.

However, practitioners, researchers, and educators in physical therapy must recognize

potential barriers and limitations to TH applications in order to safeguard patients and

promote best practice. Hence, there are several telehealth guidelines32 and

recommendations33 from key stakeholders in physical therapy. For example, proper

informed consent should be established prior to TH encounter and it should be

documented.32 Other regulation safeguards include establishing potential emergency

policies and procedures for TH applications as well as dealing with internet connectivity

barriers in practice.33

Both LifeCIT and M-MARK are based on principles of motor learning, exercise adherence

and a knowledge of neuroplasticity. Both aim to provide opportunities for intensive practice

to optimize functional recovery and prevent learned-non-use, enabling patients to

16

participate fully in everyday life. Data generated by M-MARK aims to provide therapists

with meaningful objective measures on which to base clinical decisions and predict

recovery.

Although we predict that wearable technology, used in conjunction with TH and other

rehabilitation technologies, is likely to become normal practice, there is currently a lack of

evidence for its effectiveness and therefore large well-designed pragmatic trials that are

therapist time rather than dose-matched and apply knowledge of intensity are required to

achieve reimbursement and translation in to clinical practice.

Wearable technology, as used in the M-MARK project, can be applied both in assessment

and therapy; when combined with a TH platform it could enable therapists to monitor

patients and progress their rehabilitation regimens remotely. Motivation, self-management

and independence are key factors in rehabilitation, but independent home-based

rehabilitation puts patients at risk of non-compliance and they may become de-motivated.

Web-based support systems may provide an effective way to monitor patients and an ‘early

warning’ system to identify when patients are not complying with rehabilitation regimens or

not progressing.

The cost of stroke rehabilitation is increasingly driving the need for cost-effective solutions

and practitioners must take responsibility for the cost of therapy as well as its effectiveness.

In the UK, the cost to the NHS of providing the recommended 45 minutes of upper limb

therapy 5 days a week during the recovery period of 12 weeks for the 90,000 patients who

require it each year is £216M (£2,400/patient).34 This is equivalent to $240 M or

17

$2,676/patient in US Dollars. If using technologies such as LifeCIT and M-MARK reduce the

required therapy contact by only 25% it would save £54M (Euro) or $60 M (US Dollars)

annually. Most importantly, TH may assist in more targeted and effective therapy and thus

better long-term outcomes including independence and quality of life.

Any new technology must be co-designed with ALL users. This is key to acceptance. In our

experience,11 technologies must be quick and simple for both patients, and therapists to use

and the information presented be different and appropriate for each group as well as useful

to caregivers. Technologies are tools that can augment clinical practice. Telehealth is a new

concept in health care with advances in digital technology. Therefore, we recommend that

translational practice-based research is necessary in order to advance field of TH

applications in physical therapy.

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Figure 1. The C-Mitt, which was designed to restrict functional hand movement but allowsufficient grasp to hold a walking aid.

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Figure 2. Illustrating: a) the concept of the M-MARK being used by a patient; b) an artist’s impression of the garment. Based on therapists’ and patients’ views the final design was an upper body garment rather than a sleeve

a.

b.

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The work published was funded by the UK National Institute for Health Research through the

following grants:

1. Mechanical Muscle Activity with Real-time Kinematics (M-MARK): A novel combination

of existing technologies to improve arm recovery following stroke REF: NIHR-i4i: II-LB-

0814-20006

2. Development and Pilot Evaluation of a Web-supported Programme of Constraint

Induced Therapy Following Stroke (LifeCIT) REF: RfPB PB-PG-0909-20145

The work was presented at the IV STEP Conference July 14-19 2016 Columbus Ohio.

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