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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
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
Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation
Garches, France
Propulsion force during running
Anteroposterior component of the ground reaction force (GRF), recorded during running, using force plates
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.
force plates
Propulsion forcesduring jumping and walking (force plates)
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline and at the end of the intervention (4 weeks) for the 2 interventions period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.