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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorOdense University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Frame Running Training ProgramExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline, Week 12, and Week 24

Secondary outcomes

1

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.

Time frame
Baseline, Week 12, and Week 24
2

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.

Time frame
Baseline, Week 12, and Week 24
3

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.

Time frame
Baseline, Week 12, and Week 24
4

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.

Time frame
Baseline, Week 12, and Week 24

Other outcomes

1

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.

Time frame
Baseline, Week 12, and Week 24
2

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.

Time frame
Baseline, Week 12, and Week 24
3

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.

Time frame
Ongoing from Baseline to Week 24
4

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.

Time frame
Ongoing from baseline to Week 24

Sponsors and contacts

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Odense University Hospital

Lead sponsor

University of Southern Denmark

Collaborator