Trials / Completed
CompletedNCT03003026
Bike Skills Training for Children With Cerebral Palsy
Bike Skills Training for Children With Cerebral Palsy: a Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Murdoch Childrens Research Institute · Academic / Other
- Sex
- All
- Age
- 6 Years – 15 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2016-12-05
- Primary completion
- 2018-01-31
- Completion
- 2021-07-21
- First posted
- 2016-12-26
- Last updated
- 2023-04-21
Locations
2 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT03003026. Inclusion in this directory is not an endorsement.