RecruitingNot ApplicableNCT07543614

Frame Running for 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


Sponsor

Odense University Hospital

Enrollment

35 participants

Start Date

Apr 22, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 8 YearsMax Age: 18 Years

Inclusion Criteria5

  • 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 Criteria2

  • 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).

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Interventions

BEHAVIORALFrame Running Training

The intervention consists of supervised Frame Running sessions including warm-up, technical skills practice, endurance and speed intervals, and participation-focused activities delivered according to a standardized manual.


Locations(1)

Odense University Hospital

Odense, Region Syddanmark, Denmark

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NCT07543614


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