Usability and User Experience of a Virtual Reality Rehabilitation Game Platform in Individuals With Duchenne Muscular Dystrophy

Официальное название

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

Обзор

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.

Подробное описание

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.

This study is designed as a formative evaluation to assess first-time user experience and identify potential areas for improvement in the system before future clinical studies evaluating long-term rehabilitation outcomes.

Вмешательства

• Другое Virtual Reality Gameplay Session
  Participants interact with a disease-specific virtual reality rehabilitation game platform using a fully immersive headset with hand-tracking technology during a single supervised session.

Первичные конечные точки

• Usability (System Usability Scale) [Срок оценки: Immediately after the single-session gameplay]
• Virtual Reality-Related Discomfort (Virtual Reality Sickness Questionnaire) [Срок оценки: Immediately after the single-session gameplay]
• Enjoyment (GUES - Game User Experience Satisfaction Scale - Enjoyment Subscale) [Срок оценки: Immediately after the single-session gameplay]

Вторичные конечные точки (1)

• Qualitative User Feedback [Срок оценки: Immediately after the single-session gameplay]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul University - Cerrahpasa — Istanbul

Идентификаторы

NCT: NCT07565272 · DMD-VR-UE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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