Physical DisabilityFRAME-EXNCT07543614
Frame Running for Exercise and Participation for Children and Young People With Physical Disabilities
A study testing Frame Running Training in people with Physical Disability and Physical Activity, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Physical Disability, Physical Activity, Physical Function
- What is being tested?
- Frame Running Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, Region Syddanmark, 5000
Tina Udemark Pasgaard, PT, +4524418489, pasgaard@health.sdu.dk
Camilla M Larsen, PhD, +45 2928 2025, cmla2@ucl.dk
About this study
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
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.
Read more
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.
Read the detailed description
The full protocol detailing all study procedures and methodology is available under Study Documents.
- Being tested
- Frame Running Training
- Keywords
- Frame Running, Physical activity, Physical disability, Children, Quality of life, Participation, Physical Function
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frame Running TrainingBehavioural
Also called Frame-Ex
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Frame Running Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12, and Week 24
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start22 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A quasi-experimental single-arm trial with an internal control period
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Anders Holsgaard-Larsen, Professor, Principal investigator, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark, and Department of Clinical Research, University of Southern Denmark, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543614
- Sponsor's protocol ID
- S-20232000 - 99
- Acronym
- FRAME-EX
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07543614
- Acronym / sponsor ID
- FRAME-EX / S-20232000 - 99
- Keywords
- Frame Running, Physical activity, Physical disability, Children, Quality of life, Participation, Physical Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A quasi-experimental single-arm trial with an internal control period
| Arm | Type | Receives |
|---|---|---|
| Frame Running Training Program | Experimental | Behavioral: Frame Running TrainingParticipants 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frame Running TrainingAlso: Frame-ExThe 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. | Behavioural | Frame Running Training Program |
Primary outcome
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
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anders Holsgaard-Larsen, Professor principal investigator
Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark, and Department of Clinical Research, University of Southern Denmark, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frame Running Training in people with Physical Disability and Physical Activity, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tina Udemark Pasgaard, PT (0045 24418489, pasgaard@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.