跳至主要内容
临床试验/NCT02066116
NCT02066116终止不适用

Effect of Kinect-based Upper Limb Rehabilitation System in Patients With Stroke: A Pilot Trial

Seoul National University Bundang Hospital2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2014年11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
Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2 weeks

研究概览

简要总结

The investigators have developed the kinect-based upper extremity rehabilitation program and designed this protocol to prove the efficacy of this program.

In brief, subacute stroke patients allocated to intervention group will receive the kinect based-rehabilitation program plus conventional occupational therapy and patients allocated to control group will receive the sham virtual rehabilitation plus conventional occupational therapy, for 10 days.

20 patients with subacute stroke will be allocated into each group and after completing the 10 days intervention, they will be assessed by using objective assessment tools for upper extremity function.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 20 to 80 years
  • Stroke within prior 3 months
  • Unilateral upper extremity weakness

排除标准

  • Uncontrolled medical conditions
  • Who cannot obey the simple command
  • Who has the hemispatial neglect, visual impairment, apraxia

研究组 & 干预措施

Kinect-based Rehabilitation

Experimental

干预措施: Kinect-based rehabilitation plus occupational therapy (Procedure)

Self-exercises education

Active Comparator

干预措施: sham virtual rehabilitation education plus occupational therapy (Other)

结局指标

主要结局

Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2 weeks

时间窗: Baseline, 2 weeks after the baseline

次要结局

  • Box and Block Test(Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline)
  • Modified Barthel Index(Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline)
  • Brunnstrom stage(Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline)
  • Number of movement counts during rehabilitation using accelerometer data(Baseline, 2 weeks after the baseline)

研究者

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

Nam-Jong Paik

MD, PhD

Seoul National University Bundang Hospital

研究点 (2)

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