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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03003026




Registration number
NCT03003026
Ethics application status
Date submitted
4/12/2016
Date registered
26/12/2016
Date last updated
21/04/2023

Titles & IDs
Public title
Bike Skills Training for Children With Cerebral Palsy
Scientific title
Bike Skills Training for Children With Cerebral Palsy: a Randomized Controlled Trial
Secondary ID [1] 0 0
S16-007
Secondary ID [2] 0 0
36209
Universal Trial Number (UTN)
Trial acronym
CPBIKERCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Novel task-specific bike skills training program
Other interventions - Parent-led home-based bike skills training program

Experimental: Novel task-specific program - Intervention arm - see detailed intervention group description below

Active comparator: Parent-led home-based program - Comparison arm - see detailed comparison group description below


Other interventions: Novel task-specific bike skills training program
Participants randomised to the intervention group will participate in a novel task-specific bike skills training program. The intervention involves seven key components: it is group-based, intensive (2 hours per day for 3 days plus a home program for the remaining days of the one week period), task-specific, goal-directed, and therapist led, with parent involvement and conducted in an ecological setting. Each program will be run by a physiotherapist and allied health assistant during the school holidays.

Other interventions: Parent-led home-based bike skills training program
The comparison group will involve a parent-led home-based bike skills training program. Parents of children randomized to the comparison group will receive written information and telephone support from a physiotherapist on training bike skills. They will be encouraged to work with their child towards their bike skills goals for at least 30-45 minutes per day over a one week period during the school holidays in home and community environments.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Goal attainment at 1 week post the intervention period as measured by the Goal Attainment Scale (GAS)
Timepoint [1] 0 0
1 week following intervention

Eligibility
Key inclusion criteria
* Live in Victoria, Australia
* Diagnosis of cerebral palsy
* Aged 6 - 15 years
* Independently ambulant without mobility aids
* Have goals specific to two-wheel bike skills
* Have medical clearance to participate
* Have access to an appropriate bike and helmet
* Have a primary care giver who understands written and spoken English available to participate for each participant.
Minimum age
6 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a moderate to severe intellectual impairment
* Has a dual diagnosis with another developmental disability or medical condition that may impact on their ability or safety to train two-wheel bike skills. This includes; Autism Spectrum Disorder, Trisomy 21, spina bifida, uncontrolled epilepsy, significant visual or hearing impairment as determined by medical clearance from the child's general practitioner or paediatrician
* Had musculoskeletal surgery, or other major surgery including insertion of a baclofen pump that may affect their physical ability, in the 6 months prior to randomisation or during the intervention and 12 week follow up period (if after randomisation, will be excluded from per-protocol analysis)
* Has Botulinum toxin-A (BonT-A) injections to the lower limbs and/or upper limbs in the 6 months prior to randomisation, or during the intervention and 12 week follow up period (if after randomisation, will be excluded from per-protocol analysis)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/07/2021
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment hospital [2] 0 0
The Royal Children's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Deakin University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Monash Medical Centre
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
An assessor blinded multi-centre randomized controlled trial will be conducted in which 60 participants will be randomized to either a novel task-specific approach to training bike skills or a parent-led home program comparison group. Baseline assessment will take place within 6 weeks prior to starting the intervention (T0) and outcomes will be assessed within a week following (T1); and at 12 - 14 weeks following (T2) the week long intervention. The primary outcome is attainment of individualised two-wheel bike specific goals at T1. All statistical analysis will be conducted on an intention-to-treat basis. Logistic regression will be used to assess the effect of providing the novel intervention compared to the parent-led home program on bike-specific goal attainment.
Trial website
https://clinicaltrials.gov/study/NCT03003026
Trial related presentations / publications
Toovey R, Harvey AR, McGinley JL, Lee KJ, Shih STF, Spittle AJ. Bike skills training for children with cerebral palsy: protocol for a randomised controlled trial. BMJ Open. 2018 Feb 3;8(2):e019898. doi: 10.1136/bmjopen-2017-019898.
Public notes

Contacts
Principal investigator
Name 0 0
Rachel A Toovey, PT, MPH
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03003026