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Not yet recruiting Not applicable NCT07543614

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

No applicable phase (e.g. observational)
Conditions: Physical Disability Physical Activity Physical Function Quality of Life Participation

Sponsor: Odense University Hospital

trial.available_in: БГ
Overview
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.
Description
The full protocol detailing all study procedures and methodology is available under Study Documents.
Who can participate
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).
Interventions
Frame Running Training
BEHAVIORAL
Locations 1
Denmark (1)
Odense University Hospital
Odense , Region Syddanmark
Tina Udemark Pasgaard, PT
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
8 Years
Maximum age
18 Years
Healthy volunteers
No
Start date
15.04.2026
Completion date
31.12.2027
Registry ID
NCT07543614
Source
clinicaltrials.gov
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