Bike Skills Training for Children With Cerebral Palsy (CPBIKERCT)

Murdoch Childrens Research Institute

Status

Completed

Conditions

Cerebral Palsy

Treatments

Other: Parent-led home-based bike skills training program

Other: Novel task-specific bike skills training program

Study type

Interventional

Funder types

Other

Identifiers

NCT03003026

S16-007 (Other Grant/Funding Number)

36209

HREC/116/RCHM/16 (Other Identifier)

RES-16-0000555X (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

6 to 15 years old

Volunteers

No Healthy Volunteers

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)