Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT07301593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Two Ankle Foot Orthosis on Mobility, Participation and Adhesion in Childrend With Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-18', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Propulsion force during running', 'timeFrame': 'At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.', 'description': 'Anteroposterior component of the ground reaction force (GRF), recorded during running, using force plates'}], 'secondaryOutcomes': [{'measure': 'force plates', 'timeFrame': 'At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.', 'description': 'Propulsion forcesduring jumping and walking (force plates)'}, {'measure': 'Quantitative gait analysis', 'timeFrame': 'At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.', 'description': 'Kinematics parameters during running, jumping and walking'}, {'measure': 'Quantitative Gait analysis', 'timeFrame': 'At baseline and at the end of the intervention (4 weeks) for the 2 interventions period', 'description': 'Spatiotemporal parameters during running, jumping and walking: Step length, foot clearance, single and double support time, flight phase duration during running and jump height.'}, {'measure': 'Running endurance', 'timeFrame': 'At baseline and at the end of the intervention (4 weeks) for the 2 interventions period.', 'description': 'Running endurance (using the 10 Meters Shuttle Run Test)'}, {'measure': 'Functional mobility', 'timeFrame': 'At baseline and at the end of the intervention (4 weeks) for the 2 interventions period', 'description': 'Items D and E of the Gross Motor Function Measure, with a total score ranging from 0 to 111.'}, {'measure': 'Participation in physical activities', 'timeFrame': 'At baseline and at the end of the intervention (4 weeks) for the 2 interventions period', 'description': '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'}, {'measure': 'Adhesion toward the AFOs', 'timeFrame': 'At baseline and at the end of the intervention (4 weeks) for the 2 interventions period', 'description': 'By a Follow up booklet'}, {'measure': 'Tolerance toward the AFOs', 'timeFrame': 'At baseline and at the end of the intervention (4 weeks) for the 2 interventions period', 'description': 'By a follow up booklet'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['orthosis-propulsion-running-children'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'This study is a randomized controlled trial with a crossover design. A total of 38 patients will be recruited from three different centers.\n\nEach 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.\n\n* 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.\n* 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).\n\nEach evaluation includes:\n\n* A quantitative gait analysis including ground reaction force measurements, kinematic data, and spatiotemporal parameters.\n* Clinical tests to assess functional mobility and endurance.\n* Questionnaires to evaluate participation levels, satisfaction, and acceptance of the AFOs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children from 8 to 15 years old\n* Spastic, hemiparetic cerebral palsy\n* Level I or II on the Gross Motor Function Classification System\n* Ability to walk and run 10 meters without assistance\n* Ability to jump (simultaneous lift of both feet)\n* Daily use of a plastic ankle foot orthosis allowing ankle mobility\n* Affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Children with ataxic, dyskinetic, or mixed-type cerebral palsy\n* 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.\n* Children who have received botulinum toxin injections within 4 months prior to the inclusion visit\n* Children or adolescents who have undergone surgical intervention:\n\nwithin 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.\n\n* Children who have participated in an intensive rehabilitation program within 4 months prior to the inclusion visit\n* 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."}, 'identificationModule': {'nctId': 'NCT07301593', 'acronym': 'DynamicPC', 'briefTitle': 'Comparison of Two Ankle Foot Orthosis on Mobility, Participation and Adhesion in Childrend With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Comparison of Two Ankle Foot Orthosis on Mobility, Participation and Adhesion in Childrend With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'DynamicPC'}, 'secondaryIdInfos': [{'id': '2025-A00301-48', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group carbon/plastic', 'description': 'crossover', 'interventionNames': ['Other: orthosis use']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'crossover', 'interventionNames': ['Other: orthosis use']}], 'interventions': [{'name': 'orthosis use', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Group A', 'Group carbon/plastic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'centralContacts': [{'name': 'Isabelle MEDERER', 'role': 'CONTACT', 'email': 'isabelle.mederer@aphp.fr', 'phone': '+33 1 47 10 79 18'}, {'name': 'Julie BARRADAS', 'role': 'CONTACT', 'email': 'julie.barradas@aphp.fr', 'phone': '+33 1 47 10 79 18'}], 'overallOfficials': [{'name': 'Isabelle MEDERER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}