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

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: Not yet recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: orthosis use

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: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle MEDERER; Phone Number: +33 1 47 10 79 18; Email: isabelle.mederer@aphp.fr
• Study Contact Backup: Name: Julie BARRADAS; Phone Number: +33 1 47 10 79 18; Email: julie.barradas@aphp.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Propulsion force during running	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

Outcome Measure	Measure Description	Time Frame
force plates	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	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	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	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	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	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	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	By a follow up booklet	At baseline and at the end of the intervention (4 weeks) for the 2 interventions period

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Isabelle MEDERER, Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: orthosis-propulsion-running-children
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID 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