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Completed

NCT Number: NCT06402799

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

13 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lisbeth Larsen

Copenhagen, 2200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Change in FTP test among participants

    Time frame: 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

  2. Change in timed-up-and-go test

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

    The timed-up-an-go test will change after the intervention

  3. Change in the 30-seconds sit-to-stand test

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 7, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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