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临床试验/NCT07039136
NCT07039136招募中不适用

Feasibility and Usability of Immersive VR Mirror Therapy for Upper Limb Rehabilitation

Abant Izzet Baysal University4 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2025年6月28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
172
试验地点
4
主要终点
Simulator Sickness Questionnaire

研究概览

简要总结

Mirror therapy has been shown to support motor recovery by stimulating neural mechanisms through visual feedback. Recent technological advancements, particularly in virtual reality (VR), have enabled the development of more immersive and interactive rehabilitation tools. This study focuses on evaluating the usability of a novel, Leap Motion-based Virtual Reality Mirror Therapy (VRMT) system designed to enhance upper limb rehabilitation in stroke patients by combining traditional mirror therapy principles with engaging, gamified digital environments.

详细描述

The VRMT system was developed to provide a low-cost, sensor-based rehabilitation tool that enables stroke survivors to engage in interactive upper limb exercises. Utilizing the Leap Motion sensor for real-time hand tracking, the system projects mirrored movements of the unaffected limb onto a virtual representation of the affected limb, reinforcing motor learning and neuroplasticity. The system includes multiple gamified tasks that simulate functional hand and arm movements within a virtual environment. Participants with subacute or chronic stroke used the system across several sessions, after which usability and user experience were assessed using standardized tools such as the System Usability Scale (SUS) and User Experience Questionnaire (UEQ). This approach allows for detailed feedback on comfort, satisfaction, interaction quality, and perceived effectiveness, contributing to future development and clinical integration of VR-based rehabilitation technologies.The aim of this study is to evaluate the usability, acceptability, and user experience of a Leap Motion-based Virtual Reality Mirror Therapy (VRMT) system designed to support upper limb rehabilitation in individuals with stroke. By integrating traditional mirror therapy principles with immersive virtual environments, the study seeks to determine the feasibility of using this system in clinical and home-based rehabilitation settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Stereo acuity score of 3552 arc/sec in the Titmus Fly Test
  • No prior virtual reality experience

排除标准

  • Severe sensory impairments (vision or hearing)
  • Being diagnosed with neurological disorders

研究组 & 干预措施

Virtual Reality Mirror Therapy Group

Experimental

Participants will receive virtual reality mirror therapy using head-mounted devices.

干预措施: Virtual Reality Mirror Therapy (Other)

Sham Group

Sham Comparator

Participants will receive conventional mirror therapy with mirror box and then experience mirrored hand activities in virtual reality environment.

干预措施: Conventional Mirror Therapy (Other)

Sham Group

Sham Comparator

Participants will receive conventional mirror therapy with mirror box and then experience mirrored hand activities in virtual reality environment.

干预措施: Sham Virtual Reality (Other)

结局指标

主要结局

Simulator Sickness Questionnaire

时间窗: One hour

"The SSQ evaluates 16 symptoms-including eye strain, nausea, sweating, and headache-using a four-point scale (none, mild, moderate, and severe). These symptoms are categorized into three overlapping subscales: nausea, oculomotor discomfort, and disorientation. Higher scores within each subscale reflect more intense experiences of simulator sickness. In military aviation contexts, a total SSQ score above 20 is typically interpreted as indicative of poor tolerance to simulation exposure. The total score generally ranges from 0 to 30, with higher scores indicating lower tolerance to simulated environments.

次要结局

  • Presence Questionnaire(One hour)
  • Virtual Reality Sickness Questionnaire(One hour)
  • System Usability Scale(One hour)
  • Virtual Reality System Usability Questionnaire(One hour)

研究者

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

Ramazan KURUL

Assoc. Prof

Abant Izzet Baysal University

研究点 (4)

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