Actively Recruiting
FRAME-EX - Frame Running for Exercise in Children and Young People With Disabilities: A Quasi-Experimental Single-Arm Trial
Led by Odense University Hospital · Updated on 2026-04-29
35
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
U
University of Southern Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a structured Frame Running training program can improve functional ability, participation, and quality of life in children and young people aged 8 to 18 years with physical disabilities such as cerebral palsy. This quasi-experimental single-arm trial focuses on changes in functional ability measured by the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT), as well as secondary outcomes related to mobility, endurance, daily activity performance, and health-related quality of life. Participants will take part in a 24-week Frame Running training program delivered at community athletics clubs. The program starts with a 12-week low-intensity control period involving one supervised session per week focused on familiarization. This is followed by a 12-week moderate-to-high intensity intervention period with two weekly sessions that include warm-up, technique practice, endurance and speed intervals, and activities aimed at enhancing participation. Throughout the study, data will be collected using standardized questionnaires and physical performance tests at baseline, week 12, and week 24. Participants will also keep an electronic training diary and use the Rating of Perceived Exertion-Pediatric Scale before and after selected endurance tests. Researchers will monitor changes in functional mobility, endurance, speed, strength, walking capacity, daily activities, social and cognitive function, responsibility, quality of life, and participation diversity and intensity.
CONDITIONS
Brief Title
Frame Running for Exercise and Participation for Children and Young People With Physical Disabilities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 8 to 18 years
- Diagnosed with cerebral palsy or another physical disability affecting mobility
- Some prior Frame Running experience but no structured or performance-oriented training in the past 12 weeks
- Able to propel the Frame Running bike independently
- Able to understand and follow instructions related to Frame Running activities
You will not qualify if you...
- Severe visual or cognitive impairments affecting safe participation
- Medical conditions limiting or contraindicating study involvement such as significant cardiovascular or pulmonary disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants take part in a structured Frame Running training program including warm-up, technical skills practice, endurance and speed intervals, and participation-focused activities.
One weekly supervised session for 12 weeks followed by two weekly supervised sessions for 12 weeks
Trial Site Locations
Total: 1 location
1
Odense University Hospital
Odense, Region Syddanmark, Denmark, 5000
Actively Recruiting
Research Team
T
Tina Udemark Pasgaard, PT
C
Camilla M Larsen, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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