Bike Skills Training for Children With Cerebral Palsy

NCT ID: NCT03003026

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-05
• Study Completion Date: 2021-07-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Novel task-specific program

Intervention arm - see detailed intervention group description below

Group Type: EXPERIMENTAL

Novel task-specific bike skills training program

Intervention Type: 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.

Parent-led home-based program

Comparison arm - see detailed comparison group description below

Group Type: ACTIVE_COMPARATOR

Parent-led home-based bike skills training program

Intervention Type: 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.

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.

Intervention Type: OTHER

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 Type: OTHER

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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Melbourne

OTHER

Sponsor Role: collaborator

Deakin University

OTHER

Sponsor Role: collaborator

Monash Medical Centre

OTHER

Sponsor Role: collaborator

Murdoch Childrens Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Rachel Toovey

PhD candidate | Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel A Toovey, PT, MPH

Role: PRINCIPAL_INVESTIGATOR

Murdoch Childrens Research Institute

Locations

Monash Health

Clayton, Victoria, Australia

The Royal Children's Hospital

Parkville, Victoria, Australia

Countries

Australia

References

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.

Reference Type: BACKGROUND

PMID: 29431140 (View on PubMed)

Other Identifiers

S16-007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HREC/116/RCHM/16

Identifier Type: OTHER

Identifier Source: secondary_id

RES-16-0000555X

Identifier Type: OTHER

Identifier Source: secondary_id

36209

Identifier Type: -

Identifier Source: org_study_id