Home-based E-biking Intervention Among Individuals With Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Behavioral: Home-based E-biking

• Registration Number: NCT06402799
• Lead Sponsor: University of Copenhagen

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 Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2024-05-02
• Study First Posted: 2024-05-07
• Primary Completion: 2024-05-18
• Study Completion: 2024-05-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E-biking intervention	Home-based E-biking	Home-based e-biking

Primary Outcome Measures

Name	Time	Method
Feasibility of study assessed by minimum 70% participation in planned training volume among participants	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 Outcome Measures

Name	Time	Method
Change in the 30-seconds sit-to-stand test	At the end of the study (after 12 weeks of e-biking training)	The 30-seconds sit-to-stand test will change after the intervention
Change in FTP test among participants	At the end of the study (after 12 weeks of e-biking training)	The functional threshold power test will change after the intervention as the participants achieve better fitness
Change in timed-up-and-go test	At the end of the study (after 12 weeks of e-biking training)	The timed-up-an-go test will change after the intervention

Trial Locations

Locations (1)

Lisbeth Larsen; 🇩🇰 Copenhagen, Denmark