Clinical trial Recruiting at 1 site Interventional Ages 8 to 18

Frame Running to Improve Exercise and Participation for Children and Young People With Physical Disabilities

Official title: 'FRAME-EX´ - FRAME Running for EXercise in Children and Young People With Disabilities - a Study Protocol for a Quasi-Experimental Single-Arm Trial

Run by Odense University Hospital · NCT07543614 · Data updated 2026-11-12

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.

More Physical Disability trials

Quick facts

Study typeInterventional
Ages8 Years to 18 Years
SexAll
Enrollment35 (estimated)
SponsorOdense University Hospital
Academic / other
Locations1 site (Odense, Region Syddanmark)
StatusRecruiting
StartedApril 22, 2026
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedApril 29, 2026
Trial IDNCT07543614 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.