Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402799
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2023-11-03
Brief Title:
Home-based E-biking Intervention Among Individuals With Cerebral Palsy
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
Official Title:
Research Protocol for Feasibility Testing of 12 Weeks Home-based E-biking Intervention Among Individuals With Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None