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临床试验/NCT06056219
NCT06056219已完成不适用

Effects of Rhythmic-Based Training with Immersive Mirror Visual Feedback on Sensorimotor Function of Upper Extremity

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年10月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test

研究概览

简要总结

In the proposed study, the investigators assumed that rhythmic-based training with immersive mirror visual feedback will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either rhythmic-based training with immersive mirror visual feedback, or mirror therapy on the upper extremity function and brain activity of the stroke patients.

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 (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Clinical diagnosis of stroke with unilateral side involved;
  • •A score of Mini-mental state examination greater than 24 for proving higher mental function
  • •Time of onset > 6 months before treatment begins; and
  • •Premorbid right-handedness.

排除标准

  • •Severe vision and hearing impairment;
  • •Major cognitive-perceptual deficit;
  • •Other brain disease.

研究组 & 干预措施

Virtual reality-based mirror therapy with rhythmic skill training

Experimental

30 minutes' activity of virtual reality-based mirror therapy with rhythmic skill training followed by 20 minutes' task-oriented training

干预措施: Virtual reality-based mirror therapy with rhythmic skill training (Device)

Mirror therapy using a mirror box

Active Comparator

30 minutes' exercise of mirror therapy followed by 20 minutes' task-oriented training

干预措施: Mirror therapy (Device)

Mirror therapy using a mirror box

Active Comparator

30 minutes' exercise of mirror therapy followed by 20 minutes' task-oriented training

干预措施: Task-oriented training (Other)

Virtual reality-based mirror therapy with rhythmic skill training

Experimental

30 minutes' activity of virtual reality-based mirror therapy with rhythmic skill training followed by 20 minutes' task-oriented training

干预措施: Task-oriented training (Other)

结局指标

主要结局

Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test

时间窗: baseline, 9 weeks and 21 weeks

Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The motor performance score ranges from 0 to 66 for the upper extremity.

次要结局

  • Change in the result of Box and block test(baseline, 9 weeks and 21 weeks)
  • Change in the result of Motor Activity Log(baseline, 9 weeks and 21 weeks)
  • Change in the result of Modified Ashworth scale (MAS)(baseline, 9 weeks and 21 weeks)
  • Change in the result of Semmes-Weinstein monofilament (SWM) test(baseline, 9 weeks and 21 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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