NCT07301593

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 8 Years – 15 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-01
• Primary completion: 2030-02-01
• Completion: 2030-02-01
• First posted: 2025-12-24
• Last updated: 2025-12-24

Locations

1 site across 1 country: France