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临床试验/NCT02657070
NCT02657070已完成不适用

Desaprendiendo la parálisis Aprendida Con RGS en Pacientes Afectos de Ictus

Universitat Pompeu Fabra0 个研究点目标入组 23 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
主要终点
The upper extremity Fugl-Meyer Assessment

研究概览

简要总结

The purpose of this study is to determine if Reinforcement-Induced Movement Therapy (RIMT), a novel rehabilitation method that augments visuomotor feedback of movements of the patient in virtual reality, is effective in treating hemiparesis resp. learned non-use.

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 (Participant, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mild-to-moderate upper-limbs hemiparesis (Proximal Medical Research Council Scale > 2) due to ischemic or hemorrhagic stroke
  • Spasticity in the affected limb (Modified Ashworth Scale <3)
  • First-ever ischemic or hemorrhagic stroke (>4 weeks post-stroke)
  • Sufficient cognitive capacity for following the instruction of the intervention (Mini-Mental State Evaluation >24)

排除标准

  • Cognitive impairment that impede the correct execution or understanding of the intervention
  • Severe impairments in vision or visual perception abilities (such as vision loss or spatial neglect), in spasticity, in communication abilities (such as aphasia or apraxia), severe pain as well as other neuromuscular or orthopedic changes that impede the correct execution of the intervention training
  • Mental dysfunctioning during the acute or subacute phase after the stroke.

结局指标

主要结局

The upper extremity Fugl-Meyer Assessment

时间窗: at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up

change from baseline in motor function

次要结局

  • Chedoke Arm Hand Inventory(at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up)
  • Barthel Index(at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up)
  • Hamilton Scale(at baseline, at 6-weeks (after intervention), and at 12-weeks follow-up)

研究者

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

Paul Verschure

Prof.

Universitat Pompeu Fabra

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