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临床试验/NCT02592759
NCT02592759终止不适用

Effects of Upper Extremity Rehabilitation Using Smart Glove in Stroke

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
23
试验地点
2
主要终点
Fugl-Meyer Assessment of Upper Extremity change

研究概览

简要总结

The purpose of this study is to evaluate the therapeutic effects of smart glove which is motion-based program designed for upper extremity rehabilitation after stroke.

详细描述

This study will evaluate the therapeutic effects (upper extremity power, function and activity of daily living) of smart glove which is motion-based rehabilitation program.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • CT or MRI proved 1st stroke patients with unilateral hemiplegia caused by stroke (ischemic, hemorrhagic, intracranial hemorrhage)
  • 72 hours ~ 3 months after stroke
  • Upper extremity hemiplegia with Brunnström stage 2-
  • The patients can sit to receive treatment for at least 1 hour

排除标准

  • The patients cannot perform occupational treatments because of severe hemineglect or hemianopia
  • Contracture due to severe limitation of motion
  • Upper extremity spasticity in the wrist and fingers with modified Ashworth scale > 2 points
  • Fugl-Meyer Assessment-Wrist & Hand score >= 21 points
  • moderate to severe cognitive dysfunction < MMSE 18 points
  • Severe aphasia
  • The patients who has been diagnosed as malignant tumor

研究组 & 干预措施

Smart Glove Group

Experimental

The subjects will be treated with conventional occupational therapy for 30 minutes and smart glove treatment for 30 minutes. 5 treatments per week will be conducted a total of 2 weeks.

干预措施: Smart Glove Treatment (Device)

Homework group

No Intervention

The subjects will be treated with conventional occupational therapy for 30 minutes and upper extremity rehabilitation homework which means the self training at bedside, for 30 minutes. 5 treatments per week will be conducted a total of 2 weeks.

结局指标

主要结局

Fugl-Meyer Assessment of Upper Extremity change

时间窗: Change from baseline points at 2 weeks and 6 weeks

Evaluation tool for upper extremity function

次要结局

  • Brunnström stage change(Change from baseline stage at 2 weeks and 6 weeks)
  • Modified Barthel Index change(Change from baseline points at 2 weeks and 6 weeks)
  • Care Burden Scale change(Change from baseline points at 2 weeks and 6 weeks)
  • Hand power change(Change from baseline power at 2 weeks and 6 weeks)
  • Jebsen Hand function Test change(Change from baseline points at 2 weeks and 6 weeks)
  • Box and Block Test change(Change from baseline points at 2 weeks and 6 weeks)

研究者

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

Shi-Uk Lee

Professor

Seoul National University Hospital

研究点 (2)

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