Frame Running to Improve Exercise and Participation for Children and Young People With Physical Disabilities
'FRAME-EX´ - FRAME Running for EXercise in Children and Young People With Disabilities - a Study Protocol for a Quasi-Experimental Single-Arm Trial
NA · Odense University Hospital · NCT07543614
This project will try a 24-week Frame Running training program to see if it improves function, participation, and quality of life in 8–18-year-olds with cerebral palsy or other physical disabilities.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | Odense University Hospital (other) |
| Locations | 1 site (Odense, Region Syddanmark) |
| Trial ID | NCT07543614 on ClinicalTrials.gov |
What this trial studies
This is a quasi-experimental, single-arm trial delivering a 24-week Frame Running training program in community athletics clubs for participants aged 8–18 with cerebral palsy or other mobility-limiting conditions. The program begins with a 12-week low-intensity familiarization period with one supervised weekly Frame Running session, followed by a 12-week period of increased training intensity. The primary outcome is functional ability measured with the PEDI-CAT, and secondary outcomes include mobility capacity, physical endurance, performance of everyday activities, and health-related quality of life. Full protocol details and procedures are available in the study documents.
Who should consider this trial
Good fit: Children and adolescents aged 8–18 with cerebral palsy or other physical disabilities affecting mobility who can independently propel a Frame Running bike, understand instructions, and have not participated in organized Frame Running training in the past 12 weeks are ideal candidates.
Not a fit: Patients with severe visual or cognitive impairments, significant cardiovascular or pulmonary disease, or those unable to propel a Frame Running bike independently are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could improve mobility, endurance, daily activity performance, and social participation, leading to better quality of life for participating children.
How similar studies have performed: Non-randomized and community-based Frame Running (RaceRunning) and other adapted running programs have shown promising improvements in mobility, endurance, and participation, but high-quality randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Odense, Region Syddanmark
- Odense University Hospital — Odense, Region Syddanmark, Denmark (RECRUITING)
Study contacts
- Principal investigator: Anders Holsgaard-Larsen, Professor — Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark, and Department of Clinical Research, University of Southern Denmark, Denmark
- Study coordinator: Tina Udemark Pasgaard, PT
- Email: pasgaard@health.sdu.dk
- Phone: 0045 24418489
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Physical Disability, Physical Activity, Physical Function, Quality of Life, Participation, Frame Running, Physical activity, Physical disability