Frame Running for Exercise and Participation for Children and Young People With Physical Disabilities (FRAME-EX)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Physical Activity; Physical Disability; Physical Function; Participation
• Intervention / Treatment: Behavioral: Frame Running Training

Detailed Description

The full protocol detailing all study procedures and methodology is available under Study Documents.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tina Udemark Pasgaard, PT; Phone Number: 0045 24418489; Email: pasgaard@health.sdu.dk
• Study Contact Backup: Name: Camilla M Larsen, PhD; Phone Number: +45 29282025; Email: cmla2@ucl.dk

Study Locations

• Denmark
  • Region Syddanmark
    • Odense, Region Syddanmark, Denmark, 5000
      • Recruiting
      • Odense University Hospital
      • Contact: Tina Udemark Pasgaard, PT; Phone Number: +4524418489; Email: pasgaard@health.sdu.dk
      • Contact: Camilla M Larsen, PhD; Phone Number: +45 2928 2025; Email: cmla2@ucl.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Frame 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.; Other Names: Frame-Ex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Endurance Measured by the 6-Minute Frame Running Test From Baseline to Week 12 and Week 24	Endurance will be assessed using the 6-Minute Frame Running Test, in which the child propels a frame runner for six minutes while aiming to cover the greatest possible distance. The outcome is the total distance covered in meters and reflects aerobic capacity and functional endurance during frame-based running. Higher distances indicate better endurance performance.	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.	Running speed will be assessed using the 10-Meter Frame Running Sprint Test. In this test, the child covers a distance of 10 meters as quickly as possible from a stationary start using a frame runner. The outcome is sprint time measured in seconds and reflects speed, acceleration, and explosive mobility during frame-based running. Lower sprint times indicate better performance.	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.	Functional strength will be assessed using the 1-Minute Sit-to-Stand Test, in which the child performs as many sit-to-stand repetitions as possible within one minute. The outcome is the total number of completed repetitions and reflects lower-limb strength, muscular endurance, and functional capacity relevant for daily activities. Higher scores indicate greater functional strength.	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	Walking capacity will be assessed using the 1-Minute Walk Test, which measures the distance a child can walk within one minute. The outcome is total walking distance measured in meters and provides an indicator of functional mobility, walking endurance, and walking pace. Greater distances indicate better walking capacity.	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	Functional performance will be assessed using the Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT). The Daily Activities, Social/Cognitive, and Responsibility domains evaluate a child's functional abilities in self-care and daily tasks, social interaction and cognitive functioning, and the degree of independence and responsibility for managing daily life tasks, respectively. Each domain is reported as a scaled score ranging from 20 to 80. Higher scores indicate better functional performance across all domains.	Baseline, Week 12, and Week 24
Change in Health-Related Quality of Life Measured by the Pediatric Quality of Life Inventory (PedsQL) From Baseline to Week 12 and Week 24.	Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL), a validated pediatric patient-reported outcome measure covering physical, emotional, social, and school functioning. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.	Baseline, Week 12, and Week 24
Change in Participation Diversity and Intensity Measured by the Children's Assessment of Participation and Enjoyment / Preferences for Activities of Children (CAPE-PAC) from Baseline To Week 12 and Week 24	Participation will be assessed using the Children's Assessment of Participation and Enjoyment/Preferences for Activities of Children (CAPE-PAC). The CAPE-PAC evaluates children's participation in everyday recreational, social, physical, and skill-based activities. Participation diversity is measured as the number of different activities performed, with scores ranging from 0 to 55. Participation intensity reflects how frequently activities are performed and is scored on a scale from 1 to 7, with higher scores indicating more frequent participation. Higher scores indicate greater participation diversity and intensity.	Baseline, Week 12, and Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Psychosocial Impact Measured by the Psychosocial Impact of Assistive Devices Scale (PIADS) From Baseline to Week 12 and Week 24	The psychosocial impact of assistive device use will be assessed using the Psychosocial Impact of Assistive Devices Scale (PIADS). The PIADS evaluates perceived psychosocial impact across three domains: Competence, Adaptability, and Self-Esteem. Items are rated on a 5-point Likert scale ranging from 1 (Never) to 5 (Always). Domain scores are calculated as summed scores, with ranges of 7-35 for Competence, 3-15 for Adaptability, and 5-25 for Self-Esteem. Higher scores indicate a more positive psychosocial impact of assistive device use.	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	Perceived exertion will be assessed using the Rating of Perceived Exertion-Pediatric Scale (RPE-P) immediately before and after completion of the 6-Minute Frame Running Test. The RPE-P is a child-appropriate subjective rating scale of perceived effort, with scores ranging from 1 to 10. Higher scores indicate greater perceived exertion.	Baseline, Week 12, and Week 24
Training Activity Patterns Recorded in the Participant Training Diary from baseline to week 24	Training activity patterns will be documented using a participant-reported training diary completed after each training session, with parental assistance if needed. The diary records session date, session duration, training location (club-based or home-based), and perceived training intensity rated on a numeric scale ranging from 0 to 10, with higher scores indicating higher perceived training intensity. In addition, participants rate their overall experience of the training session using a 5-point ordinal scale ranging from 1 ("Poor training") to 5 ("Best training"). The diary is used to descriptively assess training adherence, training dose, participant-reported intensity, and subjective training experience across the study period.	Ongoing from Baseline to Week 24
Coach-Reported Training Implementation From Baseline to Week 24	Coaches will complete a structured trainer log after each training session to document key characteristics of the training sessions. The log captures information relevant to the delivery and conduct of the intervention, including session participation, implementation of planned content, overall training demands, deviations from the planned session, and any adverse events. These data will be summarized descriptively to characterize intervention implementation and safety over the course of the study.	Ongoing from baseline to Week 24
Objectively assessed daily physical activity by accelerometry for three separate 2-week periods from baseline to week 24	Daily physical activity will be objectively assessed using a thigh-mounted SENS motion® accelerometer. Accelerometer data provide objective estimates of physical activity levels and movement patterns, allowing assessment of habitual daily physical activity.	Participants will wear the device for three separate 2-week periods: Week 1 - 2, Week 12 - 13 and Week 23 - 24.

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: University of Southern Denmark
• Investigators: Principal Investigator: Anders Holsgaard-Larsen, Professor, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark, and Department of Clinical Research, University of Southern Denmark, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Children; Physical activity; Physical Function; Physical disability; Participation; Frame Running
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: S-20232000 - 99

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No