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临床试验/NCT07525713
NCT07525713招募中不适用

Virtual Reality Mirror Therapy With Focused Object-Directed Attention for Neuro-Rehabilitation

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2026年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
54
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 this study, the investigators hypothesized that Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA) would yield superior therapeutic effects compared to conventional Virtual Reality Mirror Therapy (VRMT) in individuals with unilateral stroke.

The aim of this study is to compare the immediate effects of a single session of VRMT, VRMTFOA, and VRMTFOA with auditory feedback on upper extremity function and brain activity in 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
Single (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

  • 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;
  • Premorbid right-handedness.

排除标准

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

研究组 & 干预措施

Virtual Reality Mirror Therapy with Focused Object-Directed Attention (VRMTFOA)

Experimental

30 minutes of Virtual Reality Mirror Therapy with Focused Object-Directed Attention combined with 20 minutes of conventional task-oriented therapy.

干预措施: task-oriented training (Other)

Virtual Reality Mirror Therapy Group

Active Comparator

30 minutes of Virtual Reality Mirror Therapy combined with 20 minutes of conventional task-oriented therapy.

干预措施: task-oriented training (Other)

VRMTFOA with auditory feedback

Active Comparator

30 minutes of VRMTFOA with auditory feedback combined with 20 minutes of conventional task-oriented therapy.

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 maximum motor performance score is 66 points for the upper extremity.

次要结局

  • Change in the result of Modified Ashworth scale (MAS)(baseline, 9 weeks and 21 weeks)
  • Change in the result of Box and blocks test(baseline, 9 weeks and 21 weeks)
  • Change in the result of Semmes-Weinstein monofilament (SWM) test(baseline, 9 weeks and 21 weeks)
  • Change in the result of Motor Activity Log(baseline, 9 weeks and 21 weeks)
  • Surface electromyography (sEMG)(baseline, 9 weeks)
  • Clinical Global Impression (CGI) scale(9 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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