Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
The full protocol detailing all study procedures and methodology is available under Study Documents.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
Inclusion Criteria
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tina Udemark Pasgaard, PT | Contact | 0045 24418489 | pasgaard@health.sdu.dk | |
| Camilla M Larsen, PhD | Contact | +45 29282025 | cmla2@ucl.dk |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Recruiting | Odense | Region Syddanmark | 5000 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2026 | Apr 14, 2026 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
A quasi-experimental single-arm trial with an internal control period
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| 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. |