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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00301-48 | Registry Identifier | IDRCB |
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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.
Each evaluation includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group carbon/plastic | Active Comparator | crossover |
|
| Group A | Active Comparator | crossover |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| force plates | Propulsion forcesduring jumping and walking (force plates) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Isabelle MEDERER | Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation | Garches | 92380 | France |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. | 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) | 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. | 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 | 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 | 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 | At baseline and at the end of the intervention (4 weeks) for the 2 interventions period |