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临床试验/NCT02667613
NCT02667613已完成不适用

Effet de la réadaptation Sur Les déficiences, Limitations d'activité et Restriction de la Participation Des Enfants présentant Des lésions Neurologiques Non-évolutives. Part IIb

Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change in activity measure (questionnaires)

研究概览

简要总结

Studying in a RCT the changes in everyday llife activities of children with CP during HABIT-ILE or control period, changes being scored by parents and by experts.

详细描述

Studying in a RCT the changes in everyday llife activities of children with CP (unilateral and bilateral) during HABIT-ILE or control period, changes being scored by parents and by experts on ABILHAND-Kids, the PEDI, the ACTIVLM-CP and the COPM. Investigate neuroplastic changes and correlation with everyday life changes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • cerebral palsy
  • ability to make a few steps with a walking device
  • ability to pick a light object from a table with the more affected hand
  • ability to understand simple games

排除标准

  • no active seizure
  • no botulinum toxin in the 6 months previous to the intervention or during intervention time
  • major visual deficit

结局指标

主要结局

Change in activity measure (questionnaires)

时间窗: 2 weeks of intervention and 4 months (follow-up)

change in a measure of daily activities through ABILHAND-Kids, ACTIVLIM-CP and the COPM

次要结局

  • neuroplastic changes in the cortex (MRI, fMRI, DTI, TMS)(baseline and 2 weeks of intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yannick Bleyenheuft

Professor

Université Catholique de Louvain

研究点 (2)

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