Bike Skills Training for Children With Cerebral Palsy

NCT03003026 | Completed

• 4 other identifiers: 36209S16-007HREC/116/RCHM/16RES-16-0000555X
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy

Keywords

motor learning; participation

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week following intervention

Study Arms (2)

Novel task-specific program

EXPERIMENTAL

Intervention arm - see detailed intervention group description below

Other: Novel task-specific bike skills training program

Parent-led home-based program

ACTIVE COMPARATOR

Comparison arm - see detailed comparison group description below

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

Interventions

Novel task-specific bike skills training program OTHER

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.

Novel task-specific program

Parent-led home-based bike skills training program OTHER

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.

Parent-led home-based program

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• University of Melbourne: collaborator
• Deakin University: collaborator
• Monash Medical Centre: collaborator

Study Sites (2)

Monash Health

Clayton, Victoria, 3168, Australia

Location

The Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Related Publications (1)

• 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.

  PMID: 29431140 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Rachel A Toovey, PT, MPH

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate | Physiotherapist

Study Record Dates

• First Submitted: December 4, 2016
• First Posted: December 26, 2016
• Study Start: December 5, 2016
• Primary Completion: January 31, 2018
• Study Completion: July 21, 2021
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)