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临床试验/NCT07139379
NCT07139379招募中不适用

Virtual Reality Multisensory Cooperative Task-Oriented Mirror Therapy for Neuro-Rehabilitation

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年6月24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
44
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 Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Therapy (VRMCTOMT) will provide a better treatment effects than traditional virtual reality mirror therapy (VRMT) 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 VRMCTOMT, or VRMT 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
Single (Outcomes Assessor)

入排标准

年龄范围
18 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; and
  • 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 Group

Active Comparator

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

干预措施: Virtual Reality Mirror Therapy (Other)

Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy Group

Experimental

30 minutes of Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy combined with 20 minutes of conventional task-oriented therapy.

干预措施: task-oriented training (Other)

Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy Group

Experimental

30 minutes of Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy combined with 20 minutes of conventional task-oriented therapy.

干预措施: Virtual Reality-Based Generative Bimanual Cooperative Task-Oriented Mirror Therapy (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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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