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Usability and User Experience of a Virtual Reality Rehabilitation Game Platform in Individuals With Duchenne Muscular Dystrophy (DMD-VR-UE)

27. April 2026 aktualisiert von: Sahra Şirvan, Istanbul University

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

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.

Studienübersicht

Status

Anmeldung auf Einladung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

6

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

The study population consists of individuals with a clinical diagnosis of Duchenne muscular dystrophy (DMD) who are able to interact with a virtual reality-based rehabilitation system. Participants are primarily pediatric and adolescent males with varying levels of upper extremity function, including both ambulatory and non-ambulatory individuals. All participants are required to have sufficient cognitive and physical ability to understand instructions and engage in a single-session virtual reality gameplay experience.

Beschreibung

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Usability (System Usability Scale)
Zeitfenster: 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.
Immediately after the single-session gameplay
Virtual Reality-Related Discomfort (Virtual Reality Sickness Questionnaire)
Zeitfenster: 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.
Immediately after the single-session gameplay
Enjoyment (GUES - Game User Experience Satisfaction Scale - Enjoyment Subscale)
Zeitfenster: 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.
Immediately after the single-session gameplay

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Qualitative User Feedback
Zeitfenster: Immediately after the single-session gameplay
Qualitative feedback will be collected using open-ended questions to explore participants' experiences, perceived difficulties, and suggestions for improvement.
Immediately after the single-session gameplay

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

28. April 2026

Primärer Abschluss (Geschätzt)

28. Mai 2026

Studienabschluss (Geschätzt)

28. Juni 2026

Studienanmeldedaten

Zuerst eingereicht

27. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. April 2026

Zuerst gepostet (Tatsächlich)

4. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

Individual participant data (IPD) sharing has not yet been determined. Any future decision regarding data sharing will depend on institutional policies, ethical approvals, and data protection regulations. If data sharing is considered, all data will be de-identified to ensure participant confidentiality.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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