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临床试验/NCT07565272
NCT07565272Enrolling By Invitation不适用

User Experience and Usability of a Disease-Specific Virtual Reality Rehabilitation Game Platform for Individuals With Duchenne Muscular Dystrophy: A Formative Evaluation

Istanbul University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2026年4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
Enrolling By Invitation
入组人数
6
试验地点
1
主要终点
Usability (System Usability Scale)

研究概览

简要总结

This study aims to evaluate the usability, user experience, and tolerability of a virtual reality-based rehabilitation game platform specifically developed for individuals with Duchenne muscular dystrophy. Participants will complete a single-session gameplay experience using an immersive virtual reality headset with hand-tracking technology. Following the gameplay session, usability, enjoyment, and potential virtual reality-related discomfort will be assessed using standardized questionnaires and qualitative feedback. The study is exploratory and formative in nature and does not aim to evaluate clinical effectiveness.

详细描述

Duchenne muscular dystrophy (DMD) is a progressive X-linked neuromuscular disorder characterized by muscle degeneration and functional decline. As the disease progresses, upper extremity function becomes increasingly important for maintaining independence in daily activities, particularly after the loss of ambulation.

Virtual reality-based rehabilitation has emerged as a promising approach to enhance motivation, engagement, and adherence to therapeutic activities. However, most existing virtual reality applications are not specifically designed to address the functional characteristics of individuals with DMD, such as progressive muscle weakness, early fatigability, reduced proximal control, and limited range of motion.

This study evaluates a disease-specific virtual reality rehabilitation game platform developed for individuals with DMD. The platform includes multiple game scenarios targeting upper extremity movements such as reaching, grasping, object manipulation, bilateral coordination, and visually guided movements, while minimizing excessive physical demand and fatigue. The games are designed with adjustable difficulty levels and incorporate rest periods to ensure safe and comfortable interaction.

Participants will attend a single supervised study session. After a brief familiarization period, participants will interact with the virtual reality system using a fully immersive headset with hand-tracking technology. The session will include multiple rehabilitation game scenarios adapted to the participant's functional level.

Immediately following the gameplay session, usability, user experience, and tolerability will be assessed using validated questionnaires, including the System Usability Scale (SUS), the Virtual Reality Sickness Questionnaire (VRSQ), and the enjoyment subscale of the Game User Experience Satisfaction Scale (GUES). In addition, qualitative feedback will be collected through open-ended questions to capture participants' perceptions, perceived difficulties, and suggestions for improvement.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
7 Years 至 —(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Clinical diagnosis of Duchenne muscular dystrophy (DMD)
  • Aged 7 years and older
  • Brooke Upper Extremity Functional Classification level ≤ 4
  • Ability to understand and follow simple instructions
  • Ability to interact with the virtual reality system using upper extremities
  • Willingness to participate and provide informed consent (parental/guardian consent where applicable)

排除标准

  • Presence of neurological disorders other than DMD
  • Severe visual impairment that prevents interaction with the virtual reality system
  • Severe upper extremity contractures or deformities limiting participation
  • Cognitive, behavioral, or communication impairments interfering with study procedures
  • History of severe motion sickness or intolerance to virtual reality environments
  • Any medical condition that may pose a risk during participation, as determined by the investigator

研究组 & 干预措施

DMD Participants

Individuals with Duchenne muscular dystrophy who participate in a single-session virtual reality-based rehabilitation gameplay experience to evaluate usability, user experience, and tolerability.

干预措施: Virtual Reality Gameplay Session (Other)

结局指标

主要结局

Usability (System Usability Scale)

时间窗: Immediately after the single-session gameplay

Usability will be assessed using the System Usability Scale (SUS), a 10-item questionnaire scored from 0 to 100, with higher scores indicating better perceived usability.

Virtual Reality-Related Discomfort (Virtual Reality Sickness Questionnaire)

时间窗: Immediately after the single-session gameplay

Virtual reality-related discomfort will be assessed using the Virtual Reality Sickness Questionnaire (VRSQ), which evaluates symptoms associated with immersive virtual reality exposure.

Enjoyment (GUES - Game User Experience Satisfaction Scale - Enjoyment Subscale)

时间窗: Immediately after the single-session gameplay

Enjoyment will be assessed using the enjoyment subscale of the Game User Experience Satisfaction Scale (GUES), with higher scores indicating greater perceived enjoyment during gameplay.

次要结局

  • Qualitative User Feedback(Immediately after the single-session gameplay)

研究者

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

Sahra Şirvan

PhD Student

Istanbul University - Cerrahpasa

研究点 (1)

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