Clinical trial NCT06402799: Home-based E-biking Intervention Among Individuals With Cerebral Palsy
Official title: Research Protocol for Feasibility Testing of 12 Weeks Home-based E-biking Intervention Among Individuals With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Home-based
e-biking
monitoring
cerebral palsy
feasibility
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 23
Sex: ALL
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Feasibility of study assessed by minimum 70% participation in planned training volume among participants
timeFrame: At the end of the study (after 12 weeks of e-biking training)
Secondary outcomes:
measure: Change in FTP test among participants
timeFrame: At the end of the study (after 12 weeks of e-biking training)
measure: Change in timed-up-and-go test
timeFrame: At the end of the study (after 12 weeks of e-biking training)
measure: Change in the 30-seconds sit-to-stand test
timeFrame: At the end of the study (after 12 weeks of e-biking training)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Lisbeth Larsen
Study officials:
affiliation: University of Copenhagen, Department of Neuroscience, Denmark
name: Jakob Lorentzen, Professor
role: PRINCIPAL_INVESTIGATOR
References: