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

NCT07301593 | Not Yet Recruiting

• 2 other identifiers: DynamicPC2025-A00301-48
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

orthosis-propulsion-running-children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• force plates

  At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.

• Quantitative gait analysis

  At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.

• Quantitative Gait analysis

  At baseline and at the end of the intervention (4 weeks) for the 2 interventions period

• Running endurance

  At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.

• Functional mobility

  At baseline and at the end of the intervention (4 weeks) for the 2 interventions period

Study Arms (2)

Group carbon/plastic

ACTIVE COMPARATOR

crossover

Other: orthosis use

Group A

ACTIVE COMPARATOR

crossover

Other: orthosis use

Interventions

orthosis use 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; Group carbon/plastic

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 or adolescents who have undergone surgical intervention:
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation

Garches, 92380, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Isabelle MEDERER

  Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle MEDERER

CONTACT

+33 1 47 10 79 18; isabelle.mederer@aphp.fr

Julie BARRADAS

CONTACT

+33 1 47 10 79 18; julie.barradas@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 24, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2030
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (1)