Frame Running for Exercise and Participation for Children and Young People With Physical Disabilities
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Frame Running Training.
- Who it may be relevant to
- Registry conditions: Physical Disability, Physical Activity, Physical Function, Quality of Life. Basic parameters: 8 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
'FRAME-EX´ - FRAME Running for EXercise in Children and Young People With Disabilities - a Study Protocol for a Quasi-Experimental Single-Arm Trial
Overview
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
- 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.
Primary outcome measures
- 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. [Time frame: Baseline, Week 12, and Week 24]
Secondary outcome measures (7)
- Change in Endurance Measured by the 6-Minute Frame Running Test From Baseline to Week 12 and Week 24 [Time frame: 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. [Time frame: 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. [Time frame: 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 [Time frame: 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 [Time frame: 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. [Time frame: 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 [Time frame: Baseline, Week 12, and Week 24]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Denmark · 1 center
- Odense University Hospital — Odense
Identifiers
NCT: NCT07543614 · S-20232000 - 99