Comparison of Two Ankle Foot Orthosis on Mobility, Participation and Adhesion in Childrend With Cerebral Palsy
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 15 years old?
Source: NCT07301593, who can take part
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- How often do I need to come in, and for how long each time?
- Are travel costs paid?
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- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT07301593
- Record updated
- 24 December 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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 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 with ataxic, dyskinetic, or mixed-type cerebral palsy; 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.