Cerebral PalsyDynamicPCNCT07301593
Comparison of Two Ankle Foot Orthosis on Mobility, Participation and Adhesion in Childrend With Cerebral Palsy
A study testing orthosis use in people with Cerebral Palsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Children with cerebral palsy (CP) present a variety of motor impairments and activity limitations. Plastic ankle-foot orthoses (pl-AFO) are frequently prescribed to improve their gait. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- orthosis use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2026to Feb 2030
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 8 to 15 years old
- Spastic, hemiparetic cerebral palsy
- Level I or II on the Gross Motor Function Classification System
- Ability to walk and run 10 meters without assistance
- Ability to jump (simultaneous lift of both feet)
- Daily use of a plastic ankle foot orthosis allowing ankle mobility
- Affiliated to a social security scheme
Who cannot join
- Children with ataxic, dyskinetic, or mixed-type cerebral palsy
- Children with cognitive, intellectual, or behavioral disorders that may impair their understanding of instructions, the proper conduct of evaluations, or the use of assessment scales, as judged by the investigator.
- Children who have received botulinum toxin injections within 4 months prior to the inclusion visit
- Children or adolescents who have undergone surgical intervention:
- within the past 6 months prior to inclusion if no bony procedure was performed, or within the past 12 months prior to inclusion if a bony procedure was performed, or who have a planned surgical procedure during the study period.
- Children who have participated in an intensive rehabilitation program within 4 months prior to the inclusion visit
- Children or adolescents participating in another interventional study that could interfere with the outcomes of the present study by altering the subject's physical abilities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation
Garches, 92380
About this study
Children with cerebral palsy (CP) present a variety of motor impairments and activity limitations. Plastic ankle-foot orthoses (pl-AFO) are frequently prescribed to improve their gait. However, their use limit forward propulsion generation, which explains why children tend to remove their pl-AFO during recreational activities,including running and jumping. While the benefits of physical activity are proven for these children, there is no data about pl-AFO impact across a range of locomotor activities. Biomechanically optimized dynamic carbon fiber AFOs (c-AFO) are now available and may improve propulsion features in comparison with usual pl-AFOs. The investigators aim to compare the AFO-specific effects (pl-AFO vs c-AFO) on propulsion (during walking, running and jumping), to explore the consequences on social participation, as well as to evaluate the effect on the hemiparetic CP child's perception and adherence of wearing each AFO. In this prospective, multicenter, randomized controlled trial with a crossover design, 38 hemiparetic CP children from 8 to 15 years old will be evaluated with their usual pl-AFO and with a c-AFO. The pragmatic clinical approach of this study is expected to provide data to guide and optimize AFO prescription and use, while enhancing understanding of these devices and their adaptation to the actual physical activity of CP children.
Read the detailed description
This study is a randomized controlled trial with a crossover design. A total of 38 patients will be recruited from three different centers.
Each participant will be randomly assigned to one of two groups (Group c/pl or Group pl/c). Depending on the group allocation, each subject will test both types of ankle-foot orthoses (AFOs) in a different order.
- Group c/pl: Participants in Group A will first use the carbon AFO (c-AFO) for four weeks. Evaluations will be conducted before and after this period. After a washout phase, they will then use the plastic AFO (pl-AFO) for another four weeks, with evaluations conducted before and after this second phase.
- Group pl/c: Participants in Group B will follow the same protocol, but in reverse order: starting with the pl-AFO for four weeks (with pre- and post-evaluations), followed by a washout period and then four weeks with the c-AFO (again with evaluations before and after).
Each evaluation includes:
- A quantitative gait analysis including ground reaction force measurements, kinematic data, and spatiotemporal parameters.
- Clinical tests to assess functional mobility and endurance.
- Questionnaires to evaluate participation levels, satisfaction, and acceptance of the AFOs.
- Conditions
- Cerebral Palsy
- Being tested
- orthosis use
- Keywords
- orthosis-propulsion-running-children
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthosis useOther
Participants assigned to this group will wear the c-AFO for a 4-week intervention period. Outcome assessments will be conducted at baseline and at the end of the 4-week period. Following a 2-week washout phase, participants will then wear the pl- AFO for an additional 4 weeks, with identical outcome assessments performed at the corresponding baseline and endpointPlastic ankle foot orthosis or carbon ankle foot orthosis
| Study group | Role | What they receive |
|---|---|---|
| Group carbon/plastic | Active comparator | crossover Receives: Other: orthosis use |
| Group A | Active comparator | crossover Receives: Other: orthosis use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propulsion force during running
Anteroposterior component of the ground reaction force (GRF), recorded during running, using force plates
Measured: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
Secondary outcomes (8)
force plates
Propulsion forcesduring jumping and walking (force plates)
Measured: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
Quantitative gait analysis
Kinematics parameters during running, jumping and walking
Measured: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
Quantitative Gait analysis
Spatiotemporal parameters during running, jumping and walking: Step length, foot clearance, single and double support time, flight phase duration during running and jump height.
Measured: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
Running endurance
Running endurance (using the 10 Meters Shuttle Run Test)
Measured: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
Functional mobility
Items D and E of the Gross Motor Function Measure, with a total score ranging from 0 to 111.
Measured: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
Participation in physical activities
Participation in physical activities, using the Children and Adolescent Physical Activity and Sedentary Questionnaire. The questionnaire includes two subscales: physical activity, scored from 1 to 4, and sedentary behavior, scored from 1 to 6
Measured: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
Adhesion toward the AFOs
By a Follow up booklet
Measured: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
Tolerance toward the AFOs
By a follow up booklet
Measured: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study startMar 2026 (estimated)
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle MEDERER, Principal investigator, Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301593
- Sponsor's protocol ID
- DynamicPC
- Other IDs
- 2025-A00301-48
- Acronym
- DynamicPC
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Ankle Foot Orthosis on Mobility, Participation and Adhesion in Childrend With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07301593
- Acronym / sponsor ID
- DynamicPC / DynamicPC
- Conditions
- Cerebral Palsy
- Keywords
- orthosis-propulsion-running-children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 24 Dec 2025 (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.
Children with cerebral palsy (CP) present a variety of motor impairments and activity limitations. Plastic ankle-foot orthoses (pl-AFO) are frequently prescribed to improve their gait. However, their use limit forward propulsion generation, which explains why children tend to remove their pl-AFO during recreational activities,including running and jumping. While the benefits of physical activity are proven for these children, there is no data about pl-AFO impact across a range of locomotor activities. Biomechanically optimized dynamic carbon fiber AFOs (c-AFO) are now available and may improve propulsion features in comparison with usual pl-AFOs. The investigators aim to compare the AFO-specific effects (pl-AFO vs c-AFO) on propulsion (during walking, running and jumping), to explore the consequences on social participation, as well as to evaluate the effect on the hemiparetic CP child's perception and adherence of wearing each AFO. In this prospective, multicenter, randomized controlled trial with a crossover design, 38 hemiparetic CP children from 8 to 15 years old will be evaluated with their usual pl-AFO and with a c-AFO. The pragmatic clinical approach of this study is expected to provide data to guide and optimize AFO prescription and use, while enhancing understanding of these devices and their adaptation to the actual physical activity of CP children.
Detailed description
This study is a randomized controlled trial with a crossover design. A total of 38 patients will be recruited from three different centers.
Each participant will be randomly assigned to one of two groups (Group c/pl or Group pl/c). Depending on the group allocation, each subject will test both types of ankle-foot orthoses (AFOs) in a different order.
- Group c/pl: Participants in Group A will first use the carbon AFO (c-AFO) for four weeks. Evaluations will be conducted before and after this period. After a washout phase, they will then use the plastic AFO (pl-AFO) for another four weeks, with evaluations conducted before and after this second phase.
- Group pl/c: Participants in Group B will follow the same protocol, but in reverse order: starting with the pl-AFO for four weeks (with pre- and post-evaluations), followed by a washout period and then four weeks with the c-AFO (again with evaluations before and after).
Each evaluation includes:
- A quantitative gait analysis including ground reaction force measurements, kinematic data, and spatiotemporal parameters.
- Clinical tests to assess functional mobility and endurance.
- Questionnaires to evaluate participation levels, satisfaction, and acceptance of the AFOs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group carbon/plastic | Active comparator | Other: orthosis usecrossover |
| Group A | Active comparator | Other: orthosis usecrossover |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children from 8 to 15 years old
- Spastic, hemiparetic cerebral palsy
- Level I or II on the Gross Motor Function Classification System
- Ability to walk and run 10 meters without assistance
- Ability to jump (simultaneous lift of both feet)
Key exclusion criteria (7 listed)
- Children with ataxic, dyskinetic, or mixed-type cerebral palsy
- Children with cognitive, intellectual, or behavioral disorders that may impair their understanding of instructions, the proper conduct of evaluations, or the use of assessment scales, as judged by the investigator.
- Children who have received botulinum toxin injections within 4 months prior to the inclusion visit
- Children or adolescents who have undergone surgical intervention:
- within the past 6 months prior to inclusion if no bony procedure was performed, or within the past 12 months prior to inclusion if a bony procedure was performed, or who have a planned surgical procedure during the study period.
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 |
|---|---|---|
| orthosis useParticipants assigned to this group will wear the c-AFO for a 4-week intervention period. Outcome assessments will be conducted at baseline and at the end of the 4-week period. Following a 2-week washout phase, participants will then wear the pl- AFO for an additional 4 weeks, with identical outcome assessments performed at the corresponding baseline and endpointPlastic ankle foot orthosis or carbon ankle foot orthosis | Other | Group A, Group carbon/plastic |
Primary outcome
Propulsion force during running
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
Anteroposterior component of the ground reaction force (GRF), recorded during running, using force plates
8 secondary outcomes
force plates
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
Quantitative gait analysis
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
Quantitative Gait analysis
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
Running endurance
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
Functional mobility
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
Participation in physical activities
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
Adhesion toward the AFOs
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
Tolerance toward the AFOs
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
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 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Isabelle MEDERER principal investigator
Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orthosis use in people with Cerebral Palsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 24 Dec 2025. 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 France. 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 Isabelle MEDERER (+33 1 47 10 79 18, isabelle.mederer@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propulsion force during running (time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.). 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 24 Dec 2025.