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

Cerebral Palsy Clinical Trial

Official title:

Research Protocol for Feasibility Testing of 12 Weeks Home-based E-biking Intervention Among Adolescents With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06402799
• Other study ID #: H-22032100-103168
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: University of Copenhagen
• Contact: Jakob Lorentzen, Professor
• Phone: 31521131
• Email: jlorentzen[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigation of the feasibility of virtually group-based e-biking training at home. Twenty young individuals aged 13-25 years with CP (Cerebral Palsy) with a Gross Motor Function Classification System score of 1-3 are recruited for a 12-week home-based e-biking training program.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 60 Years

Eligibility

Inclusion Criteria:

• Young people with cerebral palsy (GMFCS 1-3)

• Are able to keep balance on a stationary bike

• Are able to use a touchscreen

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Behavioral:
• Home-based E-biking
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. Heart rate will be monitored as well as power in Watt at each session.

Locations

Country	Name	City	State
Denmark	Lisbeth Larsen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of study assessed by minimum 70% participation in planned training volume among participants	Number of participants who complete the study successfully assessed by percentage of completed planned training volume	At the end of the study (after 12 weeks of e-biking training)
Secondary	Change in FTP test among participants	The functional threshold power test will change after the intervention as the participants achieve better fitness	At the end of the study (after 12 weeks of e-biking training)
Secondary	Change in timed-up-and-go test	The timed-up-an-go test will change after the intervention	At the end of the study (after 12 weeks of e-biking training)
Secondary	Change in the 30-seconds sit-to-stand test	The 30-seconds sit-to-stand test will change after the intervention	At the end of the study (after 12 weeks of e-biking training)