Cerebral PalsyNCT06402799
Home-based E-biking Intervention Among Individuals With Cerebral Palsy
A study testing Home-based E-biking in people with Cerebral Palsy, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 60 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Home-based E-biking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2023to 18 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals with cerebral palsy (GMFCS 1-3)
- Are able to keep balance on a stationary bike
- Are able to use a touchscreen
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research Protocol for Feasibility Testing of 12 Weeks 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Home-based E-biking
- Keywords
- Home-based, e-biking, monitoring, cerebral palsy, feasibility
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based E-bikingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| E-biking intervention | Experimental | Home-based e-biking Receives: Behavioral: Home-based E-biking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of the study (after 12 weeks of e-biking training)
Secondary outcomes (3)
Change in FTP test among participants
The functional threshold power test will change after the intervention as the participants achieve better fitness
Measured: At the end of the study (after 12 weeks of e-biking training)
Change in timed-up-and-go test
The timed-up-an-go test will change after the intervention
Measured: At the end of the study (after 12 weeks of e-biking training)
Change in the 30-seconds sit-to-stand test
The 30-seconds sit-to-stand test will change after the intervention
Measured: At the end of the study (after 12 weeks of e-biking training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Nov 2023
- Primary completion18 May 2024
- Study completion18 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakob Lorentzen, Professor, Principal investigator, University of Copenhagen, Department of Neuroscience, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402799
- Sponsor's protocol ID
- H-22032100-103168
- Status last verified
- Aug 2024
- First submitted
- 3 Nov 2023
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Protocol for Feasibility Testing of 12 Weeks Home-based E-biking Intervention Among Individuals With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06402799
- Acronym / sponsor ID
- H-22032100-103168
- Conditions
- Cerebral Palsy
- Keywords
- Home-based, e-biking, monitoring, cerebral palsy, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 18 May 2024 (actual)
- Study completion
- 18 May 2024 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| E-biking intervention | Experimental | Behavioral: Home-based E-bikingHome-based e-biking |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Individuals with cerebral palsy (GMFCS 1-3)
- Are able to keep balance on a stationary bike
- Are able to use a touchscreen
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based E-bikingThe 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. | Behavioural | E-biking intervention |
Primary outcome
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
3 secondary outcomes
Change in FTP test among participants
Time frame: At the end of the study (after 12 weeks of e-biking training)
Change in timed-up-and-go test
Time frame: At the end of the study (after 12 weeks of e-biking training)
Change in the 30-seconds sit-to-stand test
Time frame: At the end of the study (after 12 weeks of e-biking training)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
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tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy
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Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakob Lorentzen, Professor principal investigator
University of Copenhagen, Department of Neuroscience, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based E-biking in people with Cerebral Palsy, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.