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Running head: RCT OF MITII FOR EF WITH ABI 1

Introduction

Acquired Brain Injury (ABI) is the major cause of death and disability in children and

adolescents and is defined as any insult to the brain in the post-neonatal period resulting from

either traumatic or non-traumatic aetiologies.1 It is burdensome and leads to a plethora of

health outcomes including deficits in cognitive, behavioural, psychological, and physical

functioning.2-4 Cognitive impairments including executive dysfunction are common following

an ABI.2,5-7

Executive function (EF) refers to the skills which are necessary for behaviour to accomplish

goal directed activities.8,9 Anderson’s paediatric model published in 2002 describes EF as a

sum of inter–related and inter-dependent processes which function together as a supervisory

system. The model has four distinct domains of (i) attentional control – which includes the

capacity to selectively attend to specific stimuli; (ii) information processing –the fluency,

efficiency and speed at which information is processed; (iii) cognitive flexibility –the ability

to shift between response sets and learn from mistakes and divide attention; and (iv) goal

setting – which incorporates the ability to develop new initiatives and concepts.5 Deficits in

this area can lead to many functional limitations which can have devastating effects on school

attainment, social development, behavioural regulation, and participation in everyday

activities.2,6,10,11

There is limited evidence for cognitive rehabilitation following an ABI in the paediatric

population.6,12,13 It has been demonstrated that varying levels of efficacy for cognitive

interventions with functions such as memory and attention respond better to targeted

interventions when compared to processing speed.6,12,13 Attention rehabilitation in the

paediatric ABI population has shown some positive effects for attention training and for the

use of compensatory strategies to compensate for attention difficulties following ABI.13 In

terms of the rehabilitation of executive functioning in the paediatric ABI population, there is

RCT OF MITII FOR EF WITH ABI 2

a paucity of evidence with most interventions focusing on a single aspect of EF such as

problem solving rather than multiple components of a system.13 Commensurate with these

findings, only three studies were indentified in a recent systematic review into the use of

technology-based rehabilitation strategies for executive dysfunctions in children and

adolescents with Traumatic Brain Injury (TBI).14 A meta-anlysis of these three studies only

found small to medium effects when evaluating the intervention group immediately post-

treatment compared to the placebo group using a web-based problem solving approach.14

Evidence-based recommendations from the 2007 review of cognitive and behavioural

rehabilitation treatments in children with ABI included a need for experimentally derived

studies with random assigned experimental-control groups.13 They also highlighted the

importance of active family involvement as treatment providers. The implications of the

systematic review conducted in 2016 recognised the significance and potential of internet-

delivered interventions as a way to reduce cost to family, the healthcare burden, and increase

convenience for all stakeholders.14 There is caution however, that as technology advances and

web-based interventions are developed, rigorous testing needs to be undertaken to assess the

benefit to all stakeholders and to determine whether these interventions surpass current

practices or act as adjuncts.14

“Move it to improve it” (Mitii™ ) is a novel, internet-based, multi-modal rehabilitation

program that offers intense and incrementally challenging training in the cognitive, visual

perceptual, and physical (i.e. upper limb and gross motor) function areas. The feasibility of

the program has been demonstrated in a small non-randomised pilot study of children aged 9-

13 years with UCP.15 The premise behind the program is 30 minutes of training, 6 days per

week, over 20 weeks would be sufficient to drive neuroplastic changes in the brain.16 The

second generation Mitii™ program used for the current study utilised Microsoft Kinect

(Microsoft Research, Redmond, Washington, USA) technology to track the body movements


of children as they completed each training module (Boyd et al., 2015). Virtual trainers

(Physiotherapist, Occupational Therapist, and Neuropsychologist) select from 11 Mitii™

training modules comprising 60% combined cognitive, visual perceptual, and upper limb

activities, and 40% gross motor based activities, and tailor a rehabilitation program unique to

each participant.17 As participants progress through their tailored training program, the virtual

trainers incrementally increase the intensity and complexity of the modules at weekly

intervals. Virtual trainers also provide regular support by weekly phone calls and/or email,

depending on family preference.17

While the Mitii™ program was originally designed for children with UCP (Boyd et al.,

2013), there is potential value of implementing this rehabilitation intervention in children and

adolescents with ABI who also experience cognitive, perceptual, and motor difficulties.

Based on the concepts of neuroplasticity and restorative approaches to rehabilitation, Mitii™

has the potential to improve executive functioning abilities in the paediatric ABI population

through repetition, consistency, and is supported by ease of use, is cost-effective, and relies

on family engagement. The aim of this RCT was to examine the effects of Mitii™ ™ on EF,

specifically attentional control, cognitive flexibility, goal setting, and information processing

in children with ABI. The primary hypothesis was that Mitii™ would improve performance

on tests of EF. A secondary hypothesis was that Mitii™ would improve parent ratings of

everyday EF as measured by a parent questionnaire.

Method

This parallel group randomised controlled trial was conducted according to CONSORT

guidelines in Brisbane between June 2013 and January 2015. Full ethics approval was

obtained from The Royal Children’s Hospital, Brisbane (HREC/12/QRCH/222) and from the

Medical Ethics Committee of The University of Queensland (2013000212). This RCT study


was registered with the Australian and New Zealand Clinical Trials Registry

(ANZCTR12613000403730).

Participants

The sample consisted of children and adolescents recruited across Queensland and New

South Wales who were at least 12 months post ABI that was acquired ≥28 days after full term

birth. To be included in the study participants had to i) be aged 8-16 years old; ii) be

functioning at an equivalent level of Gross Motor Function Classification Scale (GMFCS)18 I

or II; iii) have Manual Abilities Classification scale (MACS I, II, III, iv)19 have sufficient

cognitive understanding, visual and verbal abilities and co-operation to participate and

perform the required tasks; v) be medically diagnosed with an ABI and be classified with

either mild, moderate or severe complicated brain injury; and vi) be able to access the internet

at home (i.e. phone line or internet access). Children and adolescents were excluded from the

study if they had i) unstable epilepsy (i.e. frequent seizures not controlled by medication); ii)

a degenerative or metabolic condition; or iii) undergone any surgical or medical intervention

in the 6 months prior to starting the study. The GMFCS is a classification system that

assesses children’s abilities to carry out self-initiated movements whereas MACS classifies

children based on their ability to handle objects in daily activities.

Procedure

Recruitment was undertaken through referral from treating clinicians (i.e. paediatricians,

physiotherapists, neuropsychologists, occupational therapists, speech therapists, and) from

the Queensland Paediatric Rehabilitation Service (QPRS); and state-wide outreach facilities.

All prospective participants were screened for study eligibility by a rehabilitation physician.

The GMFCS level was classified by the study Physiotherapist while MACS level was

determined by the study Occupational Therapist. After obtaining verbal consent, participants

were provided with study information and informed study consent was obtained.


All eligible children and adolescents were matched in pairs by age (within 18 month age

bands) and IQ (current within a two year period of recruitment based on the Wechsler

Intelligence Scale for Children – Fourth Edition; WISC-IV)20 and pairs were randomised to

20 weeks of Mitii™ training (immediate) or 20 weeks of Care As Usual (CAU; wait-list

control). Randomisation was undertaken by randomly allocating one member of each pair

either a “1” or “2” using a computer generated number table. Treatment allocations were

recorded on a piece of folded paper and assigned to consecutively numbered opaque

envelopes which were opened by independent non-study personnel. Treatment allocations

were recorded and study personnel informed.17

Study data were collected in a specially assigned multi-purpose clinic at The University of

Queensland, Brisbane. All participants were assessed over one or two days at the baseline

time-point (T1) and the post-intervention (i.e. after 20 weeks of Mitii™ training; T2) time-

point by an Occupational Therapist, Physiotherapist, and Neuropsychologist. A MRI

assessment was performed on participants who provided additional consent. The

neuropsychological assessment took approximately 1 to 2 hours with breaks when needed for

the baseline assessment and approximately 45 minutes to 1 hour for the post-intervention

follow-up appointment. Neuropsychological assessment was typically scheduled first, in

order to limit cognitive fatigue. After baseline testing, participants who were randomised into

the immediate Mitii™ training group spent an additional day at the clinic in order to be

trained by study personnel to use the Mitii™ program. These participants were provided with

the equipment needed to complete the Mitii™ program at home for the 20 week intervention

period. Equipment included a Microsoft Kinect®, with laptop and internet dongle or sim card

being provided to families who had limited access to a computer and internet at home.

Additional physiotherapy equipment including step blocks, wobble discs, and weights were

provided to all participants as these were integrated into the Mitii™ intervention. All


participants returned after 20 weeks for post-intervention assessments. Further details on the

study dose, intervention, content, and monitoring of study fidelity are provided in the study

protocol.17

Intervention

Each participant in the Mitii™ intervention group was provided training in order to learn how

to the use the Mitii™ program. A therapist explained to participant and parents the theoretical

background and purpose of the program. Families were given motivational strategies to

encourage child participation in the program, engaged in discussion about the need for

parental supervision, and provided with a demonstration of a generic program. The Mitii™

program is designed for a range of difficulty levels (i.e. easy, moderate, or difficult) and can

be configured to left, right or bimanually impaired function.17

Once the participant returned home, the therapists (i.e. one occupational therapist, one

physiotherapist, and one neuropsychologist) used the baseline assessment results to design an

individualised Mitii™ program suited to the needs and physical capabilities of the participant.

Therapists selected from the 11 available Mitii™ modules which included modules targeted

to (i) gross motor or physical activity (e.g. repetitive star jumps); (ii) combined cognitive and

visual perception (e.g. match the concepts); or (iii) upper limb (e.g. moving upper limb to

solve a mathematical problem). Modules were selected for an individualised program time of

30 minutes. All participants were encouraged to complete their programs six days a week,

which would provide the potential dose of 60 hours over the 20 week period. Programs were

designed to include 40% gross-motor and 60% cognitive-upper limb training modules.

All participants were provided with a de-identified Mitii™ account using an alias chosen by

them. Participants were required to download the Mitii™ program onto their home computers

or laptops provided by the researchers and login using their alias and a pre-determined

password. Therapists monitored participant’s weekly progress and updated the programs


weekly, increasing or decreasing intensity and/or changing the speed, accuracy and

repetitions of individual modules in order to maintain a just right level of challenge.

Participants and families were contacted regularly via phone or email by the therapists to

provide feedback and support.

Measures

Intellectual ability. Full Scale Intelligence Quotient (FSIQ) was calculated using the WISC-

IV20, consisting of the 10 subtests of Block Design, Similarities, Digit Span, Picture

Concepts, Coding, Vocabulary, Letter-Number Sequencing, Matrix Reasoning,

Comprehension, and Symbol Search. These subtests combine to create the four indices of

verbal comprehension (VCI), perceptual reasoning (PRI), processing speed (PSI), and

working memory (WMI). The FSIQ is generated from these four index scores. Internal

consistencies documented for the VCI, PRI, WMI, and FSIQ index scores of the WISC-IV

are excellent (r=0.92 - 0.97, averaged across all age groups).20 In addition, the PSI has good

internal consistency (r=0.88, averaged across all age groups).20

Executive functioning measures. All participants completed a neuropsychological test battery

consisting of subtests from the WISC-IV, Delis-Kaplan Executive Functioning System (D-

KEFS)21, Comprehensive Trail Making Test (CTMT)22, Tower of London (TOL)23, and Test

of Everyday Attention for Children (Tea-Ch)24 designed to measure the domains of EF as

outlined by Anderson’s (2002) paediatric model of EF. Measures were selected based on ease

of administration, documented test-retest reliabilities, and as these measures had been

previously used to assess Anderson’s EF domains in similar populations. The Behaviour

Rating Inventory of Executive Function (BRIEF)25 was also administered to parents or

guardians in order to assess everyday EF.

Attentional control. Attentional control was measured using Sky Search (SS; Tea-Ch), Score!

– number of trials correct (SCORE; Tea-Ch), Inhibition time of the Colour Word Interference


Test (CWI; D-KEFS), and Conditions 2 and 3 of the CTMT. Sky Search is a visual scanning

and focused attention task with good test-retest reliability (r=0.75).24 Due to the ceiling effect

in this test, test-retest correlations are not calculated however Score! is 76.2% in agreement

within one standard deviation for test-retest.24 The CWI Inhibition task has excellent test-

retest reliabilities (r=0.90, averaged across 8-19 year olds), and the internal consistency for

the CTMT Conditions 2 and 3 is between 0.69 and 0.74.21,22

Cognitive flexibility. Cognitive flexibility was measured using Digit Span Backwards (DSB;

WISC-IV), Sky Search Dual Task (SSDT; Tea-Ch), and Condition 4 and 5 of the CTMT. The

internal consistency for the Digit Span Backwards subtest is good (r=0.87, averaged across

all age groups).20 Sky Search DT has good test-retest reliability (r = 0.81) and the internal

consistency for Conditions 4 and 5 ranges from 0.68 to 0.69.22,24

Goal setting. Goal setting was measured using the Tower Of London where participants must

solve 10 problems increasing in difficulty. Test-retest reliability for the TOL ranges from

0.28 to 0.75.23

Information processing. The information processing domain was measured using WISC-IV

Coding and Symbol Search, and the colour naming, and word reading of the CWI test (D-

KEFS). Both Coding and Symbol Search have adequate to good internal consistency (r=0.82

and 0.79 respectively) and good test re-test reliabilities (r=0.81 and 0.80 respectively).20 Test-

retest reliabilities for the colour naming and word reading subtests are r=0.79 and r=0.77

respectively.21

EF in everyday life. To measure EF in everyday life, parents or guardians completed the

BRIEF, a parent rated questionnaire. For the current study, the Behavioural Regulation Index

(BRI) and the Metacognition Index (MCI) index scores were derived for the analyses. A

Global Executive Score (GEC) was also calculated, by combining BRI and MCI. All raw

scores were standardised using T-scores, with higher T-scores indicating more clinically


significant EF difficulties in everyday life. The BRIEF is a valid measure of EF and has good

to excellent internal consistency (r=0.80-0.97) and adequate to good test-retest reliabilities

(r=0.76-0.88).25

Other measured characteristics. Parents or guardians also completed questionnaires at both

assessment time-points. The baseline questionnaire detailed family characteristics (e.g.

marital status, family type, gross family income, and employment of parent), and whether or

not the child had any additional diagnoses (e.g. intellectual or learning disability, hearing or

vision impairment, Attention Deficit Hyperactivity Disorder, or epilepsy). Children were

classified according to the Australasian Rehabilitation Outcome Centre (AROC) impairment

codes.26 Parents of children in the Mitii™ intervention group were also interviewed by a

therapist using non-standardised acceptability and feasibility exit semi-structured

questionnaire upon completion of 20-weeks of Mitii™ training.27 Participation was voluntary

for all parents and no further incentive was offered.

Statistical methods

Summary statistics are reported as mean (± standard deviation) for continuous variables and

as frequency (percentage) for categorical variables. The association between treatment group

and EF outcome at 20 weeks was investigated using least squares linear regression, with

treatment group (standard care/Mitii™) included as the main effect. According to

CONSORT28 guidelines, analyses were conducted on an intention-to-treat basis which means

individuals were analysed in the group they were allocated to, regardless of treatment dose

received. Analyses were conducted using IBM SPSS version 22.00 (Statistical Package for

the Social Sciences v22).

Results

During the recruitment process, 534 individuals were screened for inclusion in the study with

77 children and adolescents meeting inclusion criteria and 60 providing consent. Children


were matched in pairs by age and IQ and were randomised to Mitii™ (immediate; n=30) or

waitlist control (n=30) as displayed in the CONSORT flow chart in Figure 1. Two

participants (one from each group) withdrew from the study before baseline assessments took

place. Baseline demographic, social, and clinical characteristics for the remaining 58

participants are presented in Table 1. Between groups differences were tested at baseline,

with no significant differences found between groups on demographic characteristics and

WISC-IV composite scores, p > 0.005 (VCI mean difference = -1.90, 95%CI -10.12,6.32,

p=0.27; PRI mean difference = -1.48, 95%CI -10.11,7.14, p=0.71; WMI mean difference = -

0.93, 95%CI -10.71,8.85, p=0.87; PSI mean difference = -5.10, 95%CI -14.38,4.25, p=0.62;

FSIQ mean difference = -2.07, 95%CI -10.94,6.81, p=0.87).

Intervention

Participants in the Mitii™ intervention group completed an average of 17.57 hours (SD

14.85) of Mitii™ total intervention, over the 20 weeks. The average minutes of training per

participant per week ranged from 0 to 46.14 hours. Four participants in the Mitii™

intervention group were unable to complete the Mitii™ intervention or attend post

intervention assessments at 20 weeks (retention 86%). Reasons for withdrawal included an

inability to be contacted by research personnel (n=1), decline to continue in the study (n=2),

and medical reasons (n=1). Three participants in the waitlist (control) group withdrew from

the study and did not attend post intervention assessments at 20 weeks (retention 89%).

Primary outcomes

Outcomes for baseline and 20-week for the Mitii™ intervention group and wait-list control

groups are presented in Table 2. There were no significant differences at 20 weeks in EF

capacity for children in the Mitii™ intervention group as compared to children in the control

(waitlist) group on all measures of EF performance; Digits span Backwards (p=0.17; CI=-

2.23-2.21); Symbol Search (p=0.10; CI=-1.16-2.53); Coding (p=0.80; CI=-1.78-1.59);


CTMT Trail 2 (p=0.98; CI= -7.33-7.09); CTMT Trail 3 (p=0.56; CI=-5.93-9.61); CTMT

Trail 4 (p=0.10; CI= -6.40-9.12); CTMT Trail 5 (p=0.44; CI= -4.87-7.91); CWI Colour

Naming (p=0.80; CI=-1.95-2.28); CWI Word Reading (p=0.80; CI=-1.95-2.28); CWI Colour

Naming (p=0.80; CI=-1.95-2.28); TOL Total Correct (p=0.10; CI =-6.92-7.65); TEA-Ch

SkySearch (p=0.68; CI=-2.17-1.34); TEA-Ch Score! (p=0.91; CI=-1.30-2.93); and TEA-Ch

SkySearch DT (p=0.52; CI=-2.87-0.74) using linear regression analysis.

Secondary outcomes

Similarly, there were no between group differences observed at 20 weeks for measures of EF

performance as measured by the BRIEF: BRIEF GEC (p=0.66; CI =-7.27-5.36); BRIEF BRI

(p=0.62; CI =-9.44-6.51); and BRIEF MI (p=0.69; CI =-6.10-5.41).

As treated analysis

A post-hoc per protocol analysis indicated a significant and large effect of CTMT Colour

Naming subtest scores on dose levels, F(2,46)=5.54, p=0.007, ω=0.40, when separated into

care as usual (wait-list control group, M=6.92, SD=3.84, SE=0.77), less than 15 hours of

training (M=5.00, SD=3.03, SE=0.84), and more than 15 hours of training (M=9.55,

SD=2.21, SE=0.67). Pairwise comparisons corrected using Tukey revealed a significant

linear trend between training for more than 15 hours and training for less than 15 hours (mean

difference = 4.55; p=0.005) with better performance on Colour Naming for those who trained

for more than 15 hours. A trend towards significance was also found on Colour Naming

performance for those with more than 15 hours training compared to those who received care

as usual (mean difference = 2.63; p=0.09). No significant trend was observed between

training for less than 15 hours and care as usual on the Colour Naming subtest (mean

difference = -1.92; p>0.05). No additional dose effects were observed across measures of EF.

Acceptability and feasibility semi-structured questionnaire


Parents of children in the intervention group (n=21/25) reported they were satisfied with

Mitii™ and the quality of the program, and were satisfied with the support and help provided

by the research team. Parents reported that the Mitii™ program helped somewhat with

improving their child’s performance at school; problem-solving, decision-making, and

organisational skills; and somewhat helped their child improve his/her self-esteem. Positive

aspects of the program included the use of intensive therapy and flexibility of accessing the

program at home. Negative aspects of the program included lack of motivation and time

constraints, and problems with accessibility and program errors.

Discussion

This randomised controlled trial evaluating the efficacy of a novel, internet-based, multi-

modal rehabilitation program found no significant differences between Mitii™ and Care as

Usual after 20-weeks on all measures of executive functioning. While the current results are

non-significant, poor program adherence consequently prevents us from disconfirming our

hypotheses that 20 weeks of multi modal training Mitii™ would significantly improve EF

abilities and performance in children and adolescents with ABI. Participants assigned to the

intervention group did not meet the proposed training dose of 60 hours. The dose varied with

an average of 17.6 hours, substantially less than the dosage achieved by children with UCP in

previous studies.15,29 When considering dose effects, participants in the Mitii™ intervention

group who trained for more than 15 hours showed significant improvements in the Colour

Naming subtest of the D-KEFS when compared to those who trained for less than 15 hours.

No other dose effects were observed. This ultimately undermines the premise of the program

which is to provide rehabilitation that is intensive and repetitive in order to drive

neuroplasticity. The current dosage reached 28% of the planned dosage level, potentially

preventing meaningful EF changes. A similar effect was found across the larger RCT with

children in the intervention group having statistically significant changes in visual figure


ground on an occupational measure30 and an increase in functional strength on lower limbs27

however these were not considered to be clinically significant. No other secondary outcomes

reported significant improvements between groups on Occupational Therapy or

Physiotherapy for this cohort.27,30

The reduced level of adherence found in the current study may be attributed to a number of

factors and comorbidities. As indicated in the Acceptability and Feasibility exit semi-

structured questionnaire, most parents reported experiencing difficulties with internet

connectivity, lengthy download delays, and software glitches. While technical support from

therapists and telemedicine engineers were utilised by families, the home-delivered nature of

the program meant families had to have some degree of technical knowledge to troubleshoot

problems with the software. Unfortunately, some technical difficulties prevented logins

which then increased frustration and prompted disengagement from the program. Adherence

may have been confounded by fatigue and lack of concentration and attention, comorbidities

often reported in this cohort of children with ABI.31 Parents additionally reported a lack of

engagement, with suggestions of providing more choice in modules contextualised to

Australian children and adolescents, and the need for more supervision of home participation

within Mitii™.

The Mitii™ program was designed to improve upper limb functioning, together with physical

strength and visual perceptual skills. Modules in the program that were cognitive in nature

(e.g. mathematics, matched pairs and memory) were a smaller percentage of the total games

compared to the visual perception and physical activity games (i.e. less than 20%). The

cognitive component of the training may not have been sufficient to drive changes in EF. In

order to improve EF the program may have needed more specific training in EF areas. Many

of the visual perceptual and upper limb modules required attentional control, speed of

information processing and cognitive switching, however the modules did not target goal-


setting, more complex problem solving, nor require intense mental flexibility and fast

cognitive switching. Furthermore, EF relies on the novelty of activities and for problems to

be complex. The nature of repetitive training may not allow for these factors.

Mitii™ is an individualised program. There are limitations to what parameters can be

changed and at times the program was too easy for the participant. There were also times that

the participant was unable to complete tasks due to their complexity and the supervision

required. There needs to be consideration for the age of the client, their motivation,

engagement and the development of their EF skills. Executive functioning abilities develop at

different ages and often have different trajectories dependent on neurophysiological

development32,33. Future interventions should consider family factors and the child’s

behaviour which may impact their engagement with therapy in the home environment.

The current study, though not successful in terms of demonstrating an effect on brain

training, has multiple strengths in this area where there has been a paucity of research.13,14 The

study has a large sample size of participants with ABI and high retention rates (87%). The

matched pair design limited group differences at baseline and the methodology followed

CONSORT Guidelines. To our knowledge, this is the first large randomised control trial to

assess a multi-modal online intervention for children with ABI. Future research would benefit

from employing this rigorous research design to test the effectiveness of interventions for

children with ABI. Online interventions are increasingly important to deliver services to rural

and remote families, as well as providing families with intensive interventions they can

complete in their home environment. Online interventions also have the capacity to be

delivered within a school setting and so can be a flexible method of delivering much needed

intervention following the acute phase of rehabilitation. Interventions which are specific to

EF and that are contextually based may have the ability to improve EF skills. In its current

form, Mitii™ is not effective in improving EF in children with an ABI with varying levels of


function. Future research should examine the efficacy of specific interventions for EF

functioning and their generalizability to real world situations.

Clinical messages

Poor program adherence lead to non-significant findings after evaluating the efficacy

of Mitii™, a novel, web-based, multi-modal rehabilitation program.

Web-based programs need to be designed to accommodate a number of key factors

identified in the current study that contributed to poor program compliance.


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Table 1. Participant demographics and baseline characteristics of Mitii™ and Control Groups

Characteristics Mitii™ ™ (n=29) Control group

(n=29)

Age, mean (SD) 11y, 10m (2y, 6m) 11y, 11m (2y, 6m)

Age of injury, mean (SD) 5y, 9m (3y, 5m) 5y, 2m (4y)

Gender, male n (%) 15 (51.7%) 17 (58.6%)

MACS n (%)

Level I 15 (51.7%) 17 (58.6%)

Level II 12 (41.4%) 12 (41.4%)

Level III 2 (6.9%) 0 (0%)

GMFCS n (%)

Level I 12 (41.4%) 17 (58.6%)

Level II 17 (58.6%) 12 (41.4%)

Epilepsy 6 (20.7%) 3 (10.3%)

AROC codes

Stroke Haemorrhagic

Left body involvement (1.11) 3 1

Right body involvement (1.12) 1 4

Bilateral involvement (1.13) 1 1

Other (1.19) 1 0

Stroke Ischaemic

Left body involvement (1.21) 2 3

Right body involvement (1.22) 1 3


Bilateral involvement (1.23) 1 0

Brain dysfunction, non-traumatic

Other (2.13) 8 9

Brain dysfunction, traumatic

Open injury (2.21) 1 1

Closed injury (2.22) 10 7

Intellectual disability

FSIQ <80 below average (%) 4 (14%) 7 (25%)

Other diagnoses n (%)

Learning disorder 16 (55.2%) 13 (44.8%)

Hearing impairment 1 (3.5%) 0 (0%)

Vision impairment 7 (24.1%) 11 (37.9%)

ADHD 1 (3.5%) 3 (10.3%)

Autism spectrum disorder 1 (3.5%) 2 (6.9%)

VCI (WISC-IV) 82.57 ± 13.03 (n = 28) 83.24 ± 16.76

PRI (WISC-IV) 78.93 ± 16.77 80.41 ± 16.01

WMI (WISC-IV) 79.79 ± 16.76 80.72 ± 20.06

PSI (WISC-IV) 72.24 ± 18.09 77.31 ± 17.32

FSIQ (WISC-IV) 75.36 ± 14.77 (n = 28) 76.24 ± 17.84

Family type, n (%)

Original 18 (62.1%) 18 (62.1%)

Step-family 5 (17.2%) 3 (10.3%)

Sole parent 5 (17.2%) 7 (24.1%)

Other 1 (3.5%) 1 (3.5%)


Key: MACS = Manual ability level; GMFCS = Gross motor function classification scale; AROC = Australasian

Rehabilitation Outcome Centre; ADHD = Attention deficit/hyperactivity disorder; WISC-IV = Wechsler

Intelligence Scale for Children – Fourth Edition; FSIQ = Full scale intellectual Quotient; VCI = Verbal

Comprehension Index; PRI = Perceptual Reasoning Index; WMI = Working Memory Index; PSI = Processing

Speed Index


Table 2. Differences between Measures of Executive Functioning at baseline and 20 week follow up for Mitii™ and control groups (Mean ± SD)

Outcome Measure Mitii™ Intervention (n=29) Waitlist Control (n=29) MD 95% CIp

value

nBaseline mean

(SD)n

20 weeks

mean (SD)n

Baseline mean

(SD)n

20 weeks mean

(SD)

Digit Span

Backwards (WISC-

IV)

29 7.17±2.95 25 7.80±3.00 28 7.10±4.02 27 7.81±4.67 -0.01 -2.23,2.21 0.17

Symbol Search

(WISC-IV)29 5.66±2.79 25 7.72±2.82 25 7.72±2.82 26 7.04±3.66 0.68 -1.16,2.53 0.10

Coding (WISC-IV) 29 5.14±2.86 25 6.44±2.99 29 5.76±3.01 26 6.54±3.00 -0.10 -1.78,1.59 0.80

CTMT Trail 2 28 31.10±11.78 25 36.56±12.98 28 32.50±14.31 25 36.68±12.36 -0.12 -7.33,7.09 0.98

CTMT Trail 3 28 31.79±11.33 25 37.36±13.37 28 33.14±13.43 25 35.52±13.96 1.84 -5.93,9.61 0.56

CTMT Trail 4 28 30.71±7.45 25 35.60±10.89 28 30.18±13.27 25 34.24±15.92 1.36 -6.40,9.12 0.10

CTMT Trail 5 28 33.96±9.53 25 38.84±10.41 27 33.70±11.37 25 37.32±12.00 1.52 -4.87,7.91 0.44

Colour Naming (D- 28 6.71±3.53 24 7.08±3.50 29 4.69±3.99 25 6.92±3.84 0.16 -1.95,2.28 0.80


KEFS: CWI)

Word Reading (D-

KEFS: CWI)27 6.74±4.13 24 6.92±3.65 28 5.50±4.20 25 6.52±4.21 0.40 -1.87,2.67 0.25

Inhibition (D-KEFS:

CWI)27 6.70±3.48 24 8.83±3.38 28 7.07±3.53 25 7.72±3.47 1.11 -0.86,3.08 0.92

TOL Total Correct

Score28 91.50±18.80 25 93.32±14.56 26 102.31±11.01 26 95.62±20.13 0.37 -6.92,7.65 0.10

TEA-Ch Sky Search 29 6.41±2.93 25 7.24±2.96 28 6.57±3.29 26 7.65±3.26 -0.41 -2.17,1.34 0.68

TEA-Ch Score 28 7.42±3.85 24 8.38±3.67 29 6.28±3.71 25 7.56±3.70 0.82 -1.30,2.93 0.91

TEA-Ch SkySearch

DT27 4.26±3.91 24 4.46±2.99 28 4.18±3.53 25 5.52±3.27 -1.06 -2.87,0.74 0.52

BRIEF BRI 28 63.25±13.71 24 62.38±12.68 29 62.83±19.05 25 63.84±14.91 -1.47 -9.44,6.51 0.62

BRIEF MI 28 66.96±11.11 24 64.83±10.11 29 66.00±9.78 25 65.16±9.84 -0.33 -6.10,5.41 0.69

BRIEF GEC 28 66.79±12.02 24 65.00±11.06 29 66.69±11.72 25 65.96±10.91 -0.96 -7.27,5.36 0.66


Key: WL = Wait-list; WISC-IV = Wechsler Intelligence Scale for Children – Fourth Edition; CTMT = Comprehensive Trail Making Test; D-KEFS = Delis-Kaplan

Executive Function System; TOL = Tower of London; CWI = Colour Word Interference; TEA-Ch = Test of Everyday Attention for Children; BRIEF = Behaviour Rating

Inventory of Executive Functioning; BRI = Behaviour Regulation Index; MI = Metacognition Index; GEC = Global Executive Composite

* Cumulative Percentage

Table 3. Mitii™ Acceptability and Feasibility Parent-report Questionnaire at 20 weeks

(n=21)

Questions Response

Mean (SD)

Satisfaction with the program

1= Very dissatisfied; 5 = Quite satisfied; 9 = Very satisfied

How satisfied were you with the Mitii™ program that you and your

child received?

7.24 (1.61)

How satisfied were you with the quality of Mitii™ your child

received?

6.95 (1.28)

How would you rate support your child received during the Mitii™

training from the Mitii™ team?

7.95 (1.47)

How satisfied were you with the type of help received from the

Mitii™ program?

8.19 (1.03)

How satisfied were you with the amount of therapy you and your

child received with the Mitii™ program?

7.67 (1.68)

How satisfied were you with the amount of technical help and

support with the Mitii™ program you and your child received? eg.

fixing IT issues

7.33 (1.98)

How satisfied were you accessing therapy using an on line therapy

program?

7.33 (2.06)

Amount of therapy

1 = Less than usual; 5 = Same as usual; 9 = Much more than usual

Compared to the usual amount of therapy you receive, can you rate

the amount of therapy you think the Mitii™ program offered

7.91 (1.48)

Meeting your needs


1=Not net at all; 5 = Needs somewhat met; 9 = All needs met

To what extent has the program met your child’s needs? 6.95 (1.77)

Program Duration

1 = Much too long; 5 = Just Right; 9 = Much too Short

Please comment on the overall length (20 weeks) 5.05 (1.94)

Please comment on the frequency (up to daily) 4.52 (0.93)

Please comment on the daily duration (20-30 minutes) 4.76 (0.77)

Reported improvements

1 = Hasn’t helped at all; 5 = Helped Somewhat; 9 = Helped a lot

Has the Mitii™ program helped your child perform better at

school?

5.71 (2.51)

Has the Mitii™ program helped your child’s problem-solving,

decision-making, or organisational skills?

5.29 (2.49)

Has the Mitii™ program helped your child improve his/her self-

esteem?

5.19 (2.54)


Figure 1: Neuropsychology Consort flow chart

Databases (n= 531)

Excluded (based on chart review), not meeting inclusion criteria

(n= 382)

Primary outcome post-intervention completion (n=51) (T1)

20 weeks

Waitlist (n= 29)Care as usual, Regular OT/PT

(amount and contact monitored)

Matched and Randomized (n= 60)

Self-contact or other referrals (n= 3)

Immediate (n= 29)20 weeks MitiiTM training

(70 Hours multi-modal training)

Baseline T0 Assessments (n= 58)

0 weeks

Baseline Measures (T0)Classification: AROC codes, MACS, GMFCS, Height, WISC-IV Full Scale Intelligence Quotient (n = 57)Colour-Word Inference Test (D-KEFS; n = 55)Comprehensive Trail Making Test (n = 55)Tower Test (n = 54)Score! (TEA-Ch; n = 57); Score DT (TEA-Ch; n = 55)Sky Search (TEA-Ch; n = 57)BRIEF (n = 57)Strengths and Difficulties Questionnaire (SDQ; n = 53)

Post Intervention Outcomes (T1)Classification: AROC codes, MACS, GMFCS, Height, WISC-IV Digit Span (WISC-IV; n = 49)Symbol Search (WISC-IV; n = 48); Coding (WISC-IV; n = 49)Colour-Word Inference Test (D-KEFS; n = 47)Comprehensive Trail Making Test (n = 48)Tower Test (n = 49)Score! (TEA-Ch; n = 47); Score DT (TEA-Ch; n = 47)Sky Search (TEA-Ch; n = 49)BRIEF (n = 48)Strengths and Difficulties Questionnaire (SDQ; n = 46)

2 failed to proceed (Subject #41 & #49)

Contacted (n= 77)

Recruitment finalised before contacted/chart reviewed (n= 75)

Excluded:- Declined to participate (n= 15)- Ineligible based on phone review

(n= 2)

Enro

llmen

tA

lloca

tion

3 Dropouts (Subject #51, #59, #46

4 Dropouts (Subject #42, #52, & #53,

#60)


Figure 1 legend

AROC- Australasian Rehabilitation Outcomes Centre. MACS- Manual Ability Classification

System. GMFCS- Gross Motor Function Classification System. 6MWT- Six Minute Walk

Test. HiMAT- High Level Mobility Assessment Tool. TUG- Timed Up and Go. WISC-IV-

Wechsler Intelligence Scale for Children IV.

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