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

NCT06402799 | Completed

• 1 other identifier: H-22032100-103168
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Home-based; e-biking; monitoring; cerebral palsy; feasibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• Change in the 30-seconds sit-to-stand test

  At the end of the study (after 12 weeks of e-biking training)

Study Arms (1)

E-biking intervention

EXPERIMENTAL

Home-based e-biking

Behavioral: Home-based E-biking

Interventions

Home-based E-biking BEHAVIORAL

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.

E-biking intervention

Eligibility Criteria

• Age: 13 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals with cerebral palsy (GMFCS 1-3)
• Are able to keep balance on a stationary bike
• Are able to use a touchscreen

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Lisbeth Larsen

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jakob Lorentzen, Professor

  University of Copenhagen, Department of Neuroscience, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility of home-based e-biking among individuals with cerebral palsy. 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 Record Dates

• First Submitted: November 3, 2023
• First Posted: May 7, 2024
• Study Start: November 1, 2023
• Primary Completion: May 18, 2024
• Study Completion: May 18, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)