Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001149550
Ethics application status
Approved
Date submitted
20/10/2015
Date registered
28/10/2015
Date last updated
27/05/2020
Date data sharing statement initially provided
27/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
iStride: A locomotor training program for children with cerebral palsy
Scientific title
The effects of a 6 week functional electrical stimulation (FES) assisted locomotor training program compared to locomotor training alone on functional mobility in children with bilateral spastic cerebral palsy: a randomised controlled trial
Secondary ID [1] 287705 0
Nil known
Universal Trial Number (UTN)
U1111-1175-7012
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bilateral spastic cerebral palsy 296535 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296800 296800 0 0
Physiotherapy
Neurological 296828 296828 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive a 6 week FES robotic assisted locomotor training program 3 times a week for 6 weeks. Each session will be 1.5 hours in duration and will be comprised of 3 main parts. The first part will include bilateral neuromuscular electrical stimulation (NMES) to the hamstrings and quadriceps while using the RT600 - an FES robotic locomotor device that synchronises NMES during a gait cycle (30 minutes). The second part will be a treadmill body weight supported locomotor program both with and without physical facilitation (20 minutes). The treadmill program will be based on principles of fitness training using intervals that are determined by individual heart rate responses (aiming for 50-70% HRMax i.e. moderate to vigorous physical activity). Finally, children will practice overground walking in their walking frames with focus on improving functional use through lower limb patterning and steering ability (15 minutes). The remaining 25 minutes will include preparation into the harness, placement of electrodes and transfers between equipment. Attendance will be registered as well as clinical progress notes (as per standard clinical practice) to document subjective reports, objective observations, individual responses and evaluation of treatment session.
Intervention code [1] 293095 0
Rehabilitation
Comparator / control treatment
The control group will undergo a locomotor training program using the treadmill and overground walking component only. The treadmill body weight supported locomotor program will be both with and without physical facilitation (50 minutes). The treadmill program will be based on principles of fitness training using intervals that are determined by individual heart rate responses (aiming for 50-70% HRmax i.e. moderate to vigorous physical activity). Children will then practice overground walking in their walking frames with focus on improving functional use through lower limb patterning and steering ability (15 minutes). The remaining 25 minutes will include preparation into the harness and transfers between equipment. Attendance will be registered as well as clinical progress notes (as per standard clinical practice) to document subjective reports, objective observations, individual responses and evaluation of treatment session.
Control group
Active

Outcomes
Primary outcome [1] 296399 0
10 meter walk test performed in the child's usual mobility device
Timepoint [1] 296399 0
Post treatment i.e. week 6
Primary outcome [2] 296400 0
Goal Attainment Scale based on ambulation e.g. change in walking ability, change in support or supervision required.
Timepoint [2] 296400 0
Post Treatment i.e. week 6
Secondary outcome [1] 318340 0
10 meter walk test performed in the child's usual mobility device
Timepoint [1] 318340 0
Follow up ( 6 months)
Secondary outcome [2] 318341 0
Goal Attainment Scale e.g. change in walking ability, change in support or supervision required.
Timepoint [2] 318341 0
Follow up (6 months)
Secondary outcome [3] 318342 0
Mobility score on the WeeFIM
Timepoint [3] 318342 0
Post treatment i.e week 6
Secondary outcome [4] 318343 0
Mobility score on the WeeFIM
Timepoint [4] 318343 0
Follow up (6 months)
Secondary outcome [5] 318344 0
Performance and Satisfaction scores on the Canadian Occupational Performance Measure
Timepoint [5] 318344 0
Post treatment i.e. week 6
Secondary outcome [6] 318345 0
Performance and Satisfaction on the Canadian Occupational Performance Measure
Timepoint [6] 318345 0
Follow up (6 months)
Secondary outcome [7] 318346 0
Gross Motor Function Measure
Timepoint [7] 318346 0
Post treatment i.e. week 6
Secondary outcome [8] 318347 0
Gross Motor Function Measure
Timepoint [8] 318347 0
Follow up (6 months)

Eligibility
Key inclusion criteria
Children with bilateral spastic cerebral palsy (may include mixed signs with dyskinesia and hypertonia)
Aged between 5 and 12 years
Able to follow simple instructions (to perform the 10 meter walk test)
Gross motor function classification system Level III, IV or V i.e. those who typically require mobility devices to walk
Accepted to receive iRehab services through Princess Margaret Hospital (tertiary level referral)
Parent identified performance problems that include difficulty with transfers or difficulty with use of walking frame and mobility
Current use of an assistive walking device (must already have one and is currently being used)
Children must have a community therapy provider
Children must be at least 3 months post botulinum toxin injections
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Engagement in activity based rehabilitation locomotor training in the past 6 months
Uncontrolled seizure disorder
Orthopaedic Surgery in the past 12 months

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)
Once participants have been confirmed to be eligible for the study, a person uninvolved in the study will provide the allocation using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A dynamic random allocation method (i.e. minimisation) will be used. Children will be allocated to the groups using a simple coin toss by a person uninvolved in the study once 2 children have been enrolled that are (a) within 2 years of age and (b) the same GMFCS level.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The program will run for a period of 15 months. During this time, we anticipate that we will be able to recruit 20 children per group. This is based on current referral statistics to the iRehab service at Princess Margaret Hospital for Children with mobility related goals in children with bilateral spastic cerebral palsy between the ages of 5 and 12. This will be sufficient to detect a large effect in favour of the intervention group at a power of 0.80 and an alpha of 0.05 (two tailed test) for the primary outcome of mobility (effect size d=0.8).
Normality will be established for all measures through examining distributional plots, Q-plots and the Shapiro-Wilk test. For data that is normally distributed, parametric tests will be applied with means and standard deviations for each group at each assessment time point reported. For ordinal data, or where data is not normally distributed despite transformations, non-parametric tests will be applied with medians and interquartile ranges reported. Intention to treat analysis will be applied.

Mixed Models will be applied to account for repeated measures between groups over time (post treatment and follow-up) and enable within group comparisons over time (post treatment compared to baseline and follow-up compared to baseline). The advantage of the Mixed Models is that it will account for any missing data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/10/2016
Actual
1/11/2016
Date of last participant enrolment
Anticipated
28/02/2018
Actual
30/03/2018
Date of last data collection
Anticipated
28/09/2018
Actual
28/06/2018
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4493 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 10686 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 292256 0
Other Collaborative groups
Name [1] 292256 0
Telethon - Perth Children's Hospital Research Fund
Country [1] 292256 0
Australia
Primary sponsor type
Individual
Name
Dayna Pool
Address
Princess Margaret Hospital for Children
Level 2, 37-39 Hay Street
Subiaco, Western Australia
6008
Country
Australia
Secondary sponsor category [1] 290954 0
Individual
Name [1] 290954 0
Jane Valentine
Address [1] 290954 0
Princess Margaret Hospital for Children
Level 2, 37-39 Hay Street
Subiaco, Western Australia
6008
Country [1] 290954 0
Australia
Secondary sponsor category [2] 290955 0
Individual
Name [2] 290955 0
Catherine Elliott
Address [2] 290955 0
Princess Margaret Hospital for Children
Level 2, 37-39 Hay Street
Subiaco, Western Australia
6008
Country [2] 290955 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293721 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 293721 0
Ethics committee country [1] 293721 0
Australia
Date submitted for ethics approval [1] 293721 0
08/12/2015
Approval date [1] 293721 0
18/02/2016
Ethics approval number [1] 293721 0

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

Contacts
Principal investigator
Name 61090 0
Dr Dayna Pool
Address 61090 0
Princess Margaret Hospital for Children
Level 2, 37-39 Hay Street
Subiaco, Western Australia
6008
Country 61090 0
Australia
Phone 61090 0
+61 8 9340 8886
Fax 61090 0
Email 61090 0
[email protected]
Contact person for public queries
Name 61091 0
Dayna Pool
Address 61091 0
Princess Margaret Hospital for Children
Level 2, 37-39 Hay Street
Subiaco, Western Australia
6008
Country 61091 0
Australia
Phone 61091 0
+61 8 9340 8886
Fax 61091 0
Email 61091 0
[email protected]
Contact person for scientific queries
Name 61092 0
Dayna Pool
Address 61092 0
Princess Margaret Hospital for Children
Level 2, 37-39 Hay Street
Subiaco, Western Australia
6008
Country 61092 0
Australia
Phone 61092 0
+61 8 9340 8886
Fax 61092 0
Email 61092 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
This was not included in the ethics submission.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLocomotor and robotic assistive gait training for children with cerebral palsy.2021https://dx.doi.org/10.1111/dmcn.14746
N.B. These documents automatically identified may not have been verified by the study sponsor.