NCT07543614 Frame Running for Exercise and Participation for Children and Young People With Physical Disabilities
| NCT ID | NCT07543614 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Physical Disability |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2026-04-22 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2026-04-22 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this quasi-experimental single-arm trial is to evaluate whether a structured Frame Running training program can improve functional ability, participation, and quality of life in children and young people with physical disabilities. The study includes participants aged 8-18 years with cerebral palsy or other conditions causing physical disabilities. The aim of the study is to investigate changes in the primary outcome measure; functional ability using the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT), and a series of secondary outcome measures on mobility capacity, physical endurance, performance of everyday activities, and health-related quality of life in children and young people with physical disabilities. Participants will complete a 24-week training program carried out in community athletics clubs: 12-week low-intensity control period with one supervised weekly Frame Running session focused on familiarization. 12-week moderate-to-high intensity intervention period with two weekly training sessions, including warm-up, technique training, endurance and speed intervals, and participation-focused activities. Data collection comprises four standardized questionnaires, four physical performance tests conducted at multiple time points, an electronic training diary, and Rating of Perceived Exertion-Pediatric Scale (RPE-P) obtained before and after selected endurance tests.
Eligibility Criteria
Inclusion Criteria * Children and adolescents aged 8-18 years. * Diagnosed with cerebral palsy (CP) or another condition resulting in a physical disability affecting mobility. * Some prior Frame Running experience, such as informal use or occasional training, but must not have taken part in structured, organized, or performance-oriented Frame Running training within the past 12 weeks. * Able to propel the Frame Running bike forward independently * Able to understand and follow instructions related to Frame Running activities. Exclusion Criteria: * Severe visual and/or cognitive impairments that would compromise safe participation * Known medical conditions that could limit or contraindicate involvement in the study (e.g., significant cardiovascular or pulmonary disease).
Contact & Investigator
Anders Holsgaard-Larsen, Professor
PRINCIPAL INVESTIGATOR
Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark, and Department of Clinical Research, University of Southern Denmark, Denmark
Frequently Asked Questions
Who can join the NCT07543614 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Physical Disability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07543614 currently recruiting?
Yes, NCT07543614 is actively recruiting participants. Contact the research team at pasgaard@health.sdu.dk for enrollment information.
Where is the NCT07543614 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT07543614 clinical trial?
NCT07543614 is sponsored by Odense University Hospital. The principal investigator is Anders Holsgaard-Larsen, Professor at Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark, and Department of Clinical Research, University of Southern Denmark, Denmark. The trial plans to enroll 35 participants.