Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000701426
Ethics application status
Approved
Date submitted
11/05/2016
Date registered
27/05/2016
Date last updated
24/04/2019
Date data sharing statement initially provided
24/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Activity Boost Challenge: Impact of the WalkAide (Registered trademark) device plus physiotherapy on walking and physical activity in children with hemiplegic cerebral palsy.
Scientific title
A randomised controlled trial on the impact of the paediatric WalkAide 'Registered Trademark' (a drop-foot stimulator) and motor learning-based, gait focused physiotherapy on advanced motor skills and physical activity participation in children with hemiplegic cerebral palsy.
Secondary ID [1] 288988 0
None.
Universal Trial Number (UTN)
U1111-1182-6038
Trial acronym
ABC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unilateral spastic hemiplegic cerebral palsy 298395 0
Bilateral spastic cerebral palsy (if they present and are treated as an asymmetrical presentation) 304026 0
Condition category
Condition code
Physical Medicine / Rehabilitation 298692 298692 0 0
Physiotherapy
Neurological 298926 298926 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
WalkAide+physio intervention:
Physical/informational materials:
WalkAide device: WalkAide is a class II, FDA cleared medical device, designed to improve walking ability in people experiencing foot drop caused by upper motor neuron injuries or conditions such as cerebral palsy. The WalkAide set up consists of a AA battery-operated, single-channel electrical stimulator, two electrodes, and electrode leads. WalkAide is a small unit that is worn around a child’s leg, just below the knee, held in place by a cuff. WalkAide uses functional electrical stimulation and tilt sensor technology to analyse the movement of the leg and activate the weak muscles of the leg that pull the foot up. It can be used instead of an Ankle Foot Orthotic or other orthotic or brace and has been shown to improve a child’s walking pattern. WalkAide wear time is recorded by the WalkAide device and will also be monitored by questions asked during four short (5 minute) telephone calls made to the child by a member of the research team each fortnight. These calls will be made to participants in both groups, and will also ask about adherence to the physiotherapy home program.
MLGF physiotherapy sessions: Four 45 minute sessions provided fortnightly (weeks 1, 3, 5, and 7). Treatment components are selected to be in line with the child’s and parent’s goals (as articulated in the Canadian Occupational Performance Measure, co-primary outcome measure). Examples of the intervention include balance/stability work, functional strengthening, gait training, endurance/fitness, and advanced motor skill practice. The length of time spent within each area is at the discretion of the treating physiotherapist. The focus can be entirely on one area or be a mix of many areas. Physiotherapists may not use additional electrical stimulation or kinesiotape. Basic stretching, if required, is done in addition to the active intervention protocol, and is not counted in the 45 minute total. Each intervention session is documented by the physiotherapist to describe the activity involved, duration, focus of activity (e.g. balance) and whether the activity was used with the WalkAide on or off (if appropriate). A register of attendance at MLGF physiotherapy sessions will be kept for each child by the treating physiotherapist, who will also document their reported adherence with the home program.
Home physiotherapy program: The treating physiotherapist will select 2-4 exercises that have been completed in the session for the child to practice at home. The program is intended to be practiced daily - duration will depend on the activities prescribed but is intended to be around 10 minutes/day.
Additional resources provided: WalkAide user guide and wear time schedule, activity monitor user guide.

Procedures:
The WalkAide+physio group start with a 4-week WalkAide acclimatisation period with two or more orthotic visits to re-evaluate WalkAide parameters, ensure comfort/setting optimization, and if required, custom-fit a foot orthotic (FO). The first two appointments will be with the study orthotist (60 minutes each); appointments three and four will be with the orthotist or with trained paediatric physiotherapists (30-45 minutes each). The number of visits will be determined as required based on child's progress in acclimatising to the use of the WalkAide, as decided by the treating orthotist. The aim is to increase daily WalkAide wear time as tolerated, aiming for >6 hours/day.
Children will then embark on an 8-week intervention consisting of: i) WalkAide wear (targeted as by others to be >6 hours/day but actualized as at least the maximum time the child reached at the end of the 4-week acclimatization); ii) four motor learning, gait focused (MLGF) physiotherapy sessions (45 minutes every two weeks) that will emphasize dorsiflexor activation whilst working on advanced motor skills linked to child/parent(s)/guardian(s) identified individualized goals; (iii) physiotherapy home program. WalkAide settings & elicited movement will be checked and documented each session by the physiotherapist, who will email the orthotist if any adjustments are required (changes documented) as needed.
After the 8-week wear period, the child and parent will be given the opportunity to be interviewed by a researcher to discuss their experience with the intervention. Participants will return the WalkAide at this point but keep working on their individualized goals over the 4-week follow-up (no further physiotherapy sessions). They will continue to wear the FO provided with the WalkAide unless parent(s)/guardian(s)/child wish to return to their previous orthotic (if they had one) at any time during the 4-week follow-up. Any orthotic changes and reasons will be documented (e.g., tripping/falls, ankle weakness). Loss of ankle dorsiflexion range of motion beyond baseline value will prompt return to their previous orthotic or to a new prescription. The 4-week follow-up assessment will occur in whatever orthosis they are wearing at that time.
Assessments will occur at baseline, within 5 days post-intervention, and at 4-week follow-up.
Individual semi-structured interviews (30-60 minutes) will occur with a purposive sample of eight children/parent(s)/guardian(s) in the WalkAide+physio intervention to explore their experience, adherence to study protocols, and feelings about ongoing use. Families will be chosen (invited post-intervention) to provide a range of experiences across age and gender of child, WalkAide wear time, previous orthotic use, and physical activity participation. Physiotherapists and orthotists will have the option of being interviewed to discuss the perceived clinical utility after their involvement with each participant ends.
Personnel:
Eligibility assessment - Paediatric physiotherapist with 25 years experience working in disability.
Assessment sessions - Paediatric physiotherapists with at least 5 years experience working in disability and who have completed relevant training.
WalkAide fitting and fine-tuning - Senior Orthotist with at least 10 years experience working in paediatric disability field.
WalkAide fine-tuning - Paediatric physiotherapists with at least 5 years experience working in disability field and in gait rehabilitation.
Physiotherapy sessions - Paediatric physiotherapists working in the disability field and who have completed relevant training.
Interviews - PhD qualified researcher.

Mode of delivery:
Face-to-face and individualised.

Location of intervention:
Rehabilitation centre and in the community (e.g. participants' home or other suitable location as appropriate).

Blinding of child/parent(s)/guardian(s), treating physiotherapist or orthotist to group is not possible given the nature of the intervention. Intervention fidelity will be assessed as follows: To reduce expectation bias, assessing physiotherapists will be told that children receive different combinations of orthoses and/or WalkAide (which they will be told may be activated or not) through the trial. Four other processes will minimize potential bias. 1) The MLGF physiotherapy program is designed by the child’s study physiotherapist and based on the child’s goals pre-randomization using a manualized, menu-based protocol applied to both groups. 2) As a fidelity check, each session’s content is documented by the physiotherapist and reviewed post-session by the study coordinator. 3) Electrical stimulation of any form is not permitted in the physio-only group (contamination). Other mechanical means of facilitating movement (e.g., kinesiotaping) are not permitted in either group. 4) Both groups may continue ongoing participation in sport or physical activity but must discontinue other active gait-based therapy on enrollment and are not able to commence individualised sports coaching or high intensity training programs. 5) All WalkAide adjustments will be recorded with rationale for the changes.
Intervention code [1] 294641 0
Treatment: Devices
Intervention code [2] 294642 0
Rehabilitation
Comparator / control treatment
Physiotherapy only group:
The physio-only control group will continue their usual orthotic management throughout the trial. To balance attention and technology novelty effects between groups, all participants will use a activity monitor wristband device (technology) to track daily physical activity. Physio-only group participants will have an intensive set up and calibration of the device (attention), rather than the basic set up provided to the WalkAide+physio group. Physio only group participants will visit the researcher once (60 minutes) and receive at least two telephone calls (10 minutes; attention) for activity monitor calibration/testing/data review during a 4-week acclimatisation period before the MLGF physiotherapy intervention. Participants will be instructed to wear the activity monitor during waking hours (except when bathing, showering or swimming etc.) for an initial 14 day period (from time of informed consent at eligibility assessment); for 7 days prior to the second assessment (i.e. during week 12), and for 7 days prior to the final assessment (during week 16). The potential for the activity monitor to elicit behaviour change independent of the main intervention is acknowledged. Both groups will be instructed not to change physical activity behaviour and the second week of data from the baseline measurement will be used as a 'true' baseline to mitigate the novelty effect in both groups.

During the 8 week intervention phase physio-only group participants will receive four MLGF physiotherapy sessions (45-minutes every two weeks, working on advanced motor skills linked to child/parent(s)/guardian(s) individualized goals). Changes in any orthosis should only be for growth adjustments, although changes for range of motion deterioration are permitted. All adjustments must be documented with rationale for the changes.
Assessments will occur at baseline, within 5 days post-intervention, and at 4-week follow-up.
Control group
Active

Outcomes
Primary outcome [1] 298178 0
Advanced gross motor skills as assessed by the Challenge-20.
Timepoint [1] 298178 0
Baseline, within 5 days post-intervention, within 5 days post-4 week follow up.
Primary outcome [2] 298179 0
Child/parent(s)/guardian(s)'s physical activity participation goals, as measured by the Canadian Occupational Performance Measure.
Timepoint [2] 298179 0
Baseline, within 5 days post-intervention, within 5 days post-4 week follow up.
Secondary outcome [1] 323395 0
Passive ankle range of motion as measured by goniometry.
Timepoint [1] 323395 0
Baseline, within 5 days post-intervention, within 5 days post-4 week follow up.
Secondary outcome [2] 323396 0
Ankle selective motor control as measured by Boyd & Graham test.
Timepoint [2] 323396 0
Baseline, within 5 days post-intervention, within 5 days post-4 week follow up.
Secondary outcome [3] 323397 0
Selective voluntary motor control as measured by the Selective Control Assessment of Lower Extremity.
Timepoint [3] 323397 0
Baseline only.
Secondary outcome [4] 323398 0
Gait pattern as measured by the Bloorview Observational Gait Assessment.
Timepoint [4] 323398 0
Baseline, within 5 days post-intervention, within 5 days post-4 week follow up.
Secondary outcome [5] 323399 0
Walking endurance as measured by the 6 minute walk test.
Timepoint [5] 323399 0
Baseline, within 5 days post-intervention, within 5 days post-4 week follow up.
Secondary outcome [6] 323400 0
Subjective physical activity as measured by the Physical Activity Questionnaire for Children (7 day recall).
Timepoint [6] 323400 0
Baseline, within 5 days post-intervention, within 5 days post-4 week follow up.
Secondary outcome [7] 323401 0
Objective physical activity as measured by activity monitor step count (7 days).
Timepoint [7] 323401 0
Baseline, within 5 days post-acclimatisation period, within 5 days post-intervention, within 5 days post-4 week follow up.
Secondary outcome [8] 323402 0
WalkAide wear time as measured by the WalkAide software and child/parent report (for WalkAide+physio group only).
Timepoint [8] 323402 0
Ongoing during 4-week acclimatisation and 8-week intervention.
Secondary outcome [9] 324008 0
Gastocnemius spasticity as measured using the Modified Tardieu and goniometry.
Timepoint [9] 324008 0
Baseline, within 5 days post-acclimatisation period, within 5 days post-intervention, within 5 days post-4 week follow up.

Eligibility
Key inclusion criteria
1) Children and young people aged 6-19 years with a diagnosis of unilateral spastic hemiplegic cerebral palsy OR bilateral spastic cerebral palsy (if they present and are treated as an asymmetrical presentation; individuals who require treatment on both sides would be excluded), GMFCS level I or II (i.e., walk/run without any device other than an ankle or foot orthosis);
2) Able to cognitively understand the physiotherapy and WalkAide instructions;
3) Prepared to attend study appointments.
4) Willing to use the WalkAide device and gradually increase wear time over acclimcatisation period, aiming for >6 hours/day wear time for 8 weeks.
Minimum age
6 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are any of:
1) dystonia as primary contributor to their movement disorder;
2) skin allergies/reactions to adhesives/silicon;
3) lower limb Botulinum toxin or orthopaedic surgery in last 3 or 12 months respectively;
4) orthopaedic metalware around knee/leg on affected side;
5) uncontrolled seizure disorder;
6) passive ankle dorsiflexion range with knee extension of affected ankle of less than plantargrade;
7) score of 0 (no active) or 1 (EHL+ -EDL) on Selective Motor Control of dorsiflextion;
8) knee flexion contracture greater than 10 degrees flexion.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a computer-generated random sequence (www.randomizer.org; managed by an independent researcher), with stratification for age (<10 years and greater than or equal to 10 years) and varied block sizes to prevent pattern prediction and ensure balanced group numbers (20/group).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
CONSORT and SPIRIT guidelines have informed the conduct of this trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The trial is powered (n=44, allowing loss of 4 participants to follow-up) to detect a medium effect size=0.45, beta=0.80, delta=7 points (/100) between groups on the Challenge-20 (Bonferroni adjusted alpha=0.025 for co-primary outcomes; Hintz, 2001). Seven points is deemed a clinically important change on the Challenge-20 and within detectable change range (Lam et al., 2015).
Main analyses will be intent-to-treat, with secondary analyses of participants with >80% intervention adherence. Assuming normality, the primary inferential analysis will be a two-group repeated-measures MANCOVA for Challenge-20 and COPM (baseline scores as covariate). Otherwise, non-parametric test equivalents will be used. The main interval will be baseline to immediately post-intervention with secondary analysis for 4-week follow-up. To provide first-time determination of wear-time effect on Challenge-20 and COPM outcomes, multiple linear regression analysis will be used with wear time, age, gender, GMFCS level and baseline score as independent variables. Secondary outcomes will be analysed via a similar repeated measures MANCOVA (alpha=0.05).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/06/2016
Actual
25/08/2016
Date of last participant enrolment
Anticipated
31/12/2018
Actual
30/10/2018
Date of last data collection
Anticipated
Actual
4/03/2019
Sample size
Target
44
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 13206 0
5010 - Regency Park

Funding & Sponsors
Funding source category [1] 293504 0
Charities/Societies/Foundations
Name [1] 293504 0
Channel 7 Children's Research Foundation
Country [1] 293504 0
Australia
Primary sponsor type
Individual
Name
Kerry Evans
Address
c/- Novita
171 Days Road
Regency Park SA 5010
Country
Australia
Secondary sponsor category [1] 292333 0
Individual
Name [1] 292333 0
Annemarie Wright
Address [1] 292333 0
c/- Novita
171 Days Road
Regency Park SA 5010
Country [1] 292333 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294950 0
Women's and Children's Health Network Women's and Children's Hospital
Ethics committee address [1] 294950 0
Ethics committee country [1] 294950 0
Australia
Date submitted for ethics approval [1] 294950 0
11/05/2016
Approval date [1] 294950 0
06/07/2016
Ethics approval number [1] 294950 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57666 0
Ms Kerry Evans
Address 57666 0
Novita, 171 Days Road Regency Park SA 5010
Country 57666 0
Australia
Phone 57666 0
+61882438259
Fax 57666 0
Email 57666 0
[email protected]
Contact person for public queries
Name 57667 0
Kerry Evans
Address 57667 0
Novita, 171 Days Road Regency Park SA 5010
Country 57667 0
Australia
Phone 57667 0
+61 882438259
Fax 57667 0
Email 57667 0
[email protected]
Contact person for scientific queries
Name 57668 0
Kerry Evans
Address 57668 0
Novita, 171 Days Road Regency Park SA 5010
Country 57668 0
Australia
Phone 57668 0
+61882438259
Fax 57668 0
Email 57668 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have HREC approval to share this data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1916Ethical approval    368652-(Uploaded-18-04-2019-14-40-43)-Study-related document.pdf



Results publications and other study-related documents

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