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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Tina Udemark Pasgaard, PT
pasgaard@health.sdu.dk
0045 24418489
Backup
Camilla M Larsen, PhD
cmla2@ucl.dk
+45 29282025
Time Frame
Start Date: 2026-04-22
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 35
Treatments
Experimental: Frame Running Training Program
Participants receive a structured Frame Running training program delivered in community athletics clubs. The program includes a 12-week low-intensity phase with one supervised session per week, followed by a 12-week moderate-to-high intensity phase with two weekly sessions.
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital
Collaborators: University of Southern Denmark

This content was sourced from clinicaltrials.gov