Clinical Trials Directory

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

TypeNameDescription
OTHERNovel task-specific bike skills training programParticipants 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.
OTHERParent-led home-based bike skills training programThe 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.