Bike Skills Training for Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

— CPBIKERCT  

Official title:

Bike Skills Training for Children With Cerebral Palsy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003026
• Other study ID #: 36209
• Secondary ID: S16-007HREC/116/
• Status: Completed
• Phase: N/A
• Start date: December 5, 2016
• Est. completion date: July 21, 2021

Study information

• Verified date: April 2023
• Source: Murdoch Childrens Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 21, 2021
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Australia	Monash Health	Clayton	Victoria
Australia	The Royal Children's Hospital	Parkville	Victoria

Sponsors (4)

Lead Sponsor	Collaborator
Murdoch Childrens Research Institute	Deakin University, Monash Medical Centre, University of Melbourne

Country where clinical trial is conducted

Australia, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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