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

NCT07543614 | Recruiting

• 1 other identifier: S-20232000 - 99
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Physical Disability; Physical Activity; Physical Function; Quality of Life; Participation

Keywords

Frame Running; Physical activity; Physical disability; Children; Quality of life; Participation; Physical Function

Outcome Measures

Primary Outcomes (1)

• Change in Children's Functional Mobility Measured by the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) From Baseline to Week 12 and Week 24.

  Functional mobility will be assessed using the Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) Mobility domain. The PEDI-CAT Mobility domain provides a scaled score ranging from 20 to 80, with higher scores indicating better functional mobility.

  Baseline, Week 12, and Week 24

Secondary Outcomes (7)

• Change in Endurance Measured by the 6-Minute Frame Running Test From Baseline to Week 12 and Week 24

  Baseline, Week 12, and Week 24

• Change in running speed measured by the 10-Meter Frame Running Sprint Test (Seconds) from Baseline to Week 12 and Week 24.

  Baseline, Week 12, and Week 24

• Change in Functional Strength Measured by the 1-Minute Sit-to-Stand Test From Baseline to Week 12 and Week 24.

  Baseline, Week 12, and Week 24

• Change in Walking Capacity Measured by the 1-Minute Walk Test From Baseline to Week 12 and Week 24

  Baseline, Week 12, and Week 24

• Change in Functional Performance Measured by the Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) Daily Activities, Social/Cognitive, and Responsibility Domains Scaled Scores from Baseline to Week 12 and Week 24

  Baseline, Week 12, and Week 24

Other Outcomes (5)

• Change in Psychosocial Impact Measured by the Psychosocial Impact of Assistive Devices Scale (PIADS) From Baseline to Week 12 and Week 24

  Baseline, Week 12, and Week 24

• Change in Perceived Exertion Measured by the Rating of Perceived Exertion-Pediatric Scale (RPE-P) Before and After the 6-Minute Frame Running Test from baseline to Week 12 and week 24

  Baseline, Week 12, and Week 24

• Training Activity Patterns Recorded in the Participant Training Diary from baseline to week 24

  Ongoing from Baseline to Week 24

Study Arms (1)

Frame Running Training Program

EXPERIMENTAL

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.

Behavioral: Frame Running Training

Interventions

Frame Running Training BEHAVIORAL

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.

Also known as: Frame-Ex

Frame Running Training Program

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Southern Denmark: collaborator
• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Anders Holsgaard-Larsen, Professor

  Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark, and Department of Clinical Research, University of Southern Denmark, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tina Udemark Pasgaard, PT

CONTACT

0045 24418489; pasgaard@health.sdu.dk

Camilla M Larsen, PhD

CONTACT

+45 29282025; cmla2@ucl.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A quasi-experimental single-arm trial with an internal control period

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 22, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)