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临床试验/EUCTR2005-004685-17-BE
EUCTR2005-004685-17-BE进行中(未招募)不适用

A prospective placebo controlled study of botulilium toxin (BOTOX) on gait disorder induced by spastic equinovarus foot.

CUB - Hôpital Erasme0 个研究点开始时间: 2006年1月31日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • All patients will have unilateral spastic hemiplegia due to vascular or traumatic brain injury, with spastic drop foot impairing gait. Moreover, each patient will be included in a functional rehabilitation program (3 to 5 sessions/week of physiotherapy) during the study.
  • The inclusion criteria are :
  • ?Unilateral clinical symptoms
  • ?Equinus foot without fixed contracture
  • ?Cerebral lesion superior to 2 months
  • ?Independent gait with or without orthesis
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • The exclusion criteria are :
  • ?Absence of prior orthopedic surgery in the lower extremities
  • ?Absence of major cognitive disorders (MMS > 24)
  • ?Absence of others factors interfering with gait as judged by investigators

研究者

发起方
CUB - Hôpital Erasme

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