Research Protocol for Feasibility Testing of 12 Weeks Home-based E-biking Intervention Among Individuals With Cerebral Palsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Feasibility of study assessed by minimum 70% participation in planned training volume among participants
Study Overview
Brief Summary
Investigation of the feasibility of virtually group-based e-biking training at home. Individuals aged 13-60 years with CP (Cerebral Palsy) with a Gross Motor Function Classification System score of 1-3 were recruited for a 12-week home-based e-biking training program.
Detailed Description
All participants should be able to use a touchscreen, as this type of technology is used in the virtual e-biking training. Participants complete a questionnaire and subsequently engage in 12 weeks of home-based virtual e-biking training. A loaned bicycle will be provided for the training period and set up in the participants' own homes. Setup and adjustments will be performed by trained healthcare personnel. The following measurements will be taken before and after the training period: weight, height, hip-waist measurements, blood pressure, a 30-second sit-to-stand test, a timed-up-and-go test, ankle measurements, and a functional threshold power test (FTP). Seven accelerometers will be attached to the right and left arms, thighs, lower legs, and sternum using NJaP patches and worn for 72 hours at the beginning and end of the training period. The accelerometers can be easily removed after 72 hours.
The e-biking intervention consists of 3 sessions per week at the beginning of the study and gradually increases over the training period to 6 sessions per week, with three of these sessions being online and group-supervised.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals with cerebral palsy (GMFCS 1-3)
- •Are able to keep balance on a stationary bike
- •Are able to use a touchscreen
Exclusion Criteria
- Not provided
Arms & Interventions
E-biking intervention
Home-based e-biking
Intervention: Home-based E-biking (Behavioral)
Outcomes
Primary Outcomes
Feasibility of study assessed by minimum 70% participation in planned training volume among participants
Time Frame: At the end of the study (after 12 weeks of e-biking training)
Number of participants who complete the study successfully assessed by percentage of completed planned training volume
Secondary Outcomes
- Change in the 30-seconds sit-to-stand test(At the end of the study (after 12 weeks of e-biking training))
- Change in FTP test among participants(At the end of the study (after 12 weeks of e-biking training))
- Change in timed-up-and-go test(At the end of the study (after 12 weeks of e-biking training))