Participation, Physical Activity, Physical Disability, Physical Function, Quality of Life
Conditions
Keywords
Frame Running, Physical activity, Physical disability, Children, Quality of life, Participation, Physical Function
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.
Detailed description
The full protocol detailing all study procedures and methodology is available under Study Documents.
Interventions
BEHAVIORALFrame 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.
Sponsors
Odense University Hospital
University of Southern Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
A quasi-experimental single-arm trial with an internal control period
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| Change in Health-Related Quality of Life Measured by the Pediatric Quality of Life Inventory (PedsQL) From Baseline to Week 12 and Week 24. | Baseline, 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. |
| 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 | Baseline, 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. |
Countries
Denmark
Contacts
CONTACTTina Udemark Pasgaard, PT
CONTACTCamilla M Larsen, PhD
PRINCIPAL_INVESTIGATORAnders Holsgaard-Larsen, Professor
Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark, and Department of Clinical Research, University of Southern Denmark, Denmark
Outcome results
None listed