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临床试验 NCT07301593 (DynamicPC) 针对脑瘫目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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大巴黎大学医院两种踝足矫形器对脑瘫儿童活动能力、参与度与依从性的比较 (DynamicPC) 38 随机化 交叉设计
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临床试验NCT07301593 (DynamicPC)是一项针对脑瘫的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年3月1日开始，预计招募38名患者。该研究由大巴黎大学医院主导，计划于2030年2月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年12月24日。
简要概括
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 ...显示更多
详细描述
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 A...
官方标题
Comparison of Two Ankle Foot Orthosis on Mobility, Participation and Adhesion in Childrend With Cerebral Palsy
疾病
脑瘫其他研究标识符
- DynamicPC
- 2025-A00301-48 (注册标识符) (IDRCB)
NCT编号
实际开始日期
2026-03
最近更新发布
2025-12-24
预计完成日期
2030-02
计划入组人数
38
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
orthosis-propulsion-running-children
主要目的
治疗方法
分配方式
随机
干预模型
交叉设计
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照Group carbon/plastic crossover | 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 orthos...显示更多 |
阳性对照Group A crossover | 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 orthos...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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. |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 | 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 |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
8 Years
适龄性别
全部
- 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
- Children with ataxic, dyskinetic, or mixed-type cerebral palsy
- 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 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 or adolescents participating in another interventional study that could interfere with the outcomes of the present study by altering the subject's physical abilities.
大巴黎大学医院967 个活跃的临床试验可供探索研究中心联系人
联系人: Isabelle MEDERER, +33 1 47 10 79 18, [email protected]
联系人: Julie BARRADAS, +33 1 47 10 79 18, [email protected]
1 位于 1 个国家/地区的研究中心
Hôpital Raymond Poincaré - Service Neurologie Pédiatrique Médecine Physique et Réadaptation, Garches, 92380, France