Bike Skills Training for Children With Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Parent-led home-based bike skills training program; Other: Novel task-specific bike skills training program

• Registration Number: NCT03003026
• Lead Sponsor: Murdoch Childrens Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-04
• Study Start: 2016-12-05
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-26
• Primary Completion: 2018-01-31
• Study Completion: 2021-07-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parent-led home-based program	Parent-led home-based bike skills training program	Comparison arm - see detailed comparison group description below
Novel task-specific program	Novel task-specific bike skills training program	Intervention arm - see detailed intervention group description below

Primary Outcome Measures

Name	Time	Method
Goal attainment at 1 week post the intervention period as measured by the Goal Attainment Scale (GAS)	1 week following intervention	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.

Trial Locations

Locations (2)

The Royal Children's Hospital; 🇦🇺 Parkville, Victoria, Australia

Monash Health; 🇦🇺 Clayton, Victoria, Australia