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

NCT ID: NCT07301593

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2030-02-28

Brief 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. 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.

Conditions

Cerebral Palsy

Keywords

orthosis-propulsion-running-children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group carbon/plastic

crossover

Group Type: ACTIVE_COMPARATOR

orthosis use

Intervention Type: OTHER

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

Group A

crossover

Group Type: ACTIVE_COMPARATOR

orthosis use

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle MEDERER

Role: PRINCIPAL_INVESTIGATOR

Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation

Locations

Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation

Garches, , France

Countries

France

Central Contacts

Isabelle MEDERER

Role: CONTACT

Phone: +33 1 47 10 79 18

Email: isabelle.mederer@aphp.fr

Julie BARRADAS

Role: CONTACT

Phone: +33 1 47 10 79 18

Email: julie.barradas@aphp.fr

Other Identifiers

2025-A00301-48

Identifier Type: REGISTRY

Identifier Source: secondary_id

DynamicPC

Identifier Type: -

Identifier Source: org_study_id