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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03003026
Ethics application status
Date submitted
4/12/2016
Date registered
26/12/2016
Date last updated
12/03/2020

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) - The GAS is a criterion referenced tool for individualized and collaborative goal setting between the child, family and therapist. Two to three individualized goals specific to two-wheel bike riding per participant will be set at the baseline visit with six potential outcomes specified for each goal from (-3 (deterioration), -2 (equal to start), -1 (less than expected), 0 (expected), 1 (somewhat more than expected), 2 (more than expected)). For each goal, attainment is defined as a score of zero or above on the GAS. The primary outcome, goal attainment, will be defined as attainment of at least one goal to an expected (score of zero) or greater level.
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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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
Other publications