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临床试验/NCT04287673
NCT04287673已完成不适用

Associated Disorders of Locomotion and Postural Control of Axial Segments in Cerebral Palsy

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2016年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
2
主要终点
Change of the peak of ankle negative power during the weight acceptance phase of gait

研究概览

简要总结

Gait abnormalities, which occur in Cerebral Palsy (CP), are characterized usually by a toe-to-floor or a plantar-to-floor initial contact (equinus gait), followed by an early braking of the tibia's forward progression (during ankle dorsiflexion). This causes consequently a trunk deceleration. Moreover, children with CP have difficulties to stabilize the trunk and the head in the space, and that could have impact on gait. If equinus gait is often attributed to the triceps surae spasticity, recent works suggest rather that this early braking of the dorsiflexion could be a motor adaptation to axial postural control difficulties. This thesis project aims firstly to attest that locomotor disorders are related to these difficulties in the stabilization of the axial body segments in children with CP and, secondly, to show that improving the trunk and head postural control with a specific rehabilitation protocol could reduce the early braking of the dorsiflexion and, consequently, the gait abnormalities observed in CP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Gross Motor Function Classification System I or II
  • no or minimal contracture of the triceps surae
  • presence of soleus spasticity

排除标准

  • botulinum toxin injections or surgery in the lower limb respectively in the 6 and 12 months preceding the study
  • any modification of the physical or orthopaedic therapy within the last two months
  • minimal hip flexion above 20° in a clinical examination
  • pain in the lower legs when standing or walking

结局指标

主要结局

Change of the peak of ankle negative power during the weight acceptance phase of gait

时间窗: Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation

In watts per kg.

Change of the peak of trunk's anterior deceleration during the weight acceptance phase of gait

时间窗: Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation

In m/s²

Change of the score of the Trunk Control Measurement Scale (TCMS)

时间窗: Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation

Score from 0 to 58. The higher the score, the better the trunk control.

Change of the center of pressure sway area during unstable sitting posturography

时间窗: Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation

In mm²

Change of the center of pressure velicoty during unstable sitting posturography

时间窗: Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation

In mm²/s

Change of the peak of the center of mass downward deceleration during the weight acceptance phase of gait

时间窗: Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation

In m/s²

次要结局

  • Change of the Dimensionless walking speed(Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation)
  • Change of the center of pressure sway area during quiet standing(Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation)
  • Change of the dimensionless step width(Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation)
  • Change of the center of pressure velicoty during quiet standing(Change from baseline to the end of the first 3-months period of rehabilitation and from this latter to the end of the second 3-months period of rehabilitation)

研究者

发起方
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
申办方类型
Other
责任方
Sponsor

研究点 (2)

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