Comparison of Two Ankle Foot Orthosis on Mobility, Participation and Adhesion in Childrend With Cerebral Palsy (DynamicPC)

December 10, 2025 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Garches, France, 92380
        • Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group carbon/plastic
crossover
Other: orthosis use
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
Active Comparator: Group A
crossover
Other: orthosis use
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
force plates
Time Frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
Propulsion forcesduring jumping and walking (force plates)
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.
Kinematics parameters during running, jumping and walking
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
Spatiotemporal parameters during running, jumping and walking: Step length, foot clearance, single and double support time, flight phase duration during running and jump height.
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.
Running endurance (using the 10 Meters Shuttle Run Test)
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
Items D and E of the Gross Motor Function Measure, with a total score ranging from 0 to 111.
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
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
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
By a Follow up booklet
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
By a follow up booklet
At baseline and at the end of the intervention (4 weeks) for the 2 interventions period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Isabelle MEDERER, Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DynamicPC
  • 2025-A00301-48 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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