Clinical trial NCT03003026: Bike Skills Training for Children With Cerebral Palsy
Official title: Bike Skills Training for Children With Cerebral Palsy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: motor learning
participation
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: University of Melbourne
name: Deakin University
name: Monash Medical Centre
First posted: 2016-12-26
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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)

Primary outcomes:
measure: Goal attainment at 1 week post the intervention period as measured by the Goal Attainment Scale (GAS)
timeFrame: 1 week following intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Parkville
country: Australia
facility: The Royal Children's Hospital
state: Victoria
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Rachel A Toovey, PT, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.