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临床试验/EUCTR2009-009868-31-NL
EUCTR2009-009868-31-NL进行中(未招募)不适用

Quality of life, gross motor function, and actual everyday physical activity level in children with spastic Cerebral Palsy: (cost)effectiveness of combined treatment with multilevel botulinum-toxin injections and intensive functional physiotherapy.

ZonMW0 个研究点开始时间: 2009年5月4日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
ZonMW

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

  • Children with spastic Cerebral Palsy aged 4-12 years whose lower extremity is involved and who have been selected for treatment with multilevel botulinum toxin injections followed by intensive physiotherapy are eligible candidates.
  • Spastic CP will be diagnosed according to the guidelines of the Dutch Institute for Healthcare Improvement. Only children classified as levels I-III with the Gross Motor Function Classification System (GMFCS) will be included for the study because they are (household) ambulators.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • The children’s´ motor selectivity should be sufficient (to be measured by valid selectivity test), and they are excluded in case of surgery <12 months before the study and in case of BtA treatment <6 months preceding the study. Children will also be excluded when severe contractures are present, when they are cognitively unable to understand instructions, or when there is co-morbidity (e.g. visual disability, severe epilepsis) that affects their everyday functioning.

研究者

发起方
ZonMW

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