Validity and Reliability of a Mixed Reality-Based 6-Minute Walk Test

Официальное название

Validity and Reliability of a Mixed Reality-Based Adaptation of the 6-Minute Walk Test in Asymptomatic Adults

Обзор

The 6-Minute Walk Test (6MWT) is a widely used field test for assessing functional exercise capacity, walking endurance, and submaximal performance related to activities of daily living. However, in conventional applications, environmental conditions, observer-related differences, and standardization issues may lead to variability in measurement outcomes. In addition, evaluating only the total walking distance may not adequately reflect clinically important changes such as performance decline and walking-related motor fatigue occurring during the test. For this reason, recent studies have recommended analyzing 6MWT data by dividing the test into minute-by-minute segments and using performance change metrics such as the Distance Walked Index (DWI). These approaches allow a more detailed evaluation of changes in walking performance throughout the test duration. With advances in measurement technologies, mixed reality (MR)-based applications have attracted attention as a means of enabling more objective, standardized, and reproducible implementation of conventional clinical tests. MR technology allows users to maintain interaction with the real environment while receiving digital guidance and feedback, thereby providing a safe and standardized assessment setting. Nevertheless, evidence regarding the validity and reliability of mixed reality-based adaptations of the 6MWT, particularly in asymptomatic adults, remains limited. The aim of this study is to evaluate the criterion validity and test-retest reliability of a mixed reality-based 6-Minute Walk Test (MR-6MWT) developed using the Meta Quest 3 and Unity platform. In addition, convergent validity will be examined by analyzing the relationships between total walking distance, minute-by-minute performance changes, fatigue effect (%), and outcomes of the 4-Meter Walk Test, Timed Up and Go Test, and knee extensor muscle strength. The findings of this study are expected to contribute to the development of a more objective, standardized, and digitally based mixed reality adaptation of the 6MWT. Furthermore, the results may provide a scientific foundation for future remote assessment and digital monitoring applications.

Вмешательства

• Другое Mixed Reality-Based 6-Minute Walk Test Assessment
  Participants will perform a mixed reality-based adaptation of the 6-Minute Walk Test (MR-6MWT) developed using the Meta Quest 3 headset and Unity platform. The mixed reality environment provides standardized visual guidance and virtual markers while allowing participants to safely walk in the real environment. During both conventional and MR-based assessments, walking distance, physiological responses, perceived exertion, and fatigue-related performance changes will be recorded. The MR-6MWT will

Первичные конечные точки

• 6-Minute Walk Distance - Mixed Reality (MR-6MWT) [Срок оценки: Baseline and 1-week follow-up]
• Fatigue Effect During the Mixed Reality-Based 6-Minute Walk Test [Срок оценки: Baseline and 1-week follow-up]

Вторичные конечные точки (6)

• 6-Minute Walk Distance - Conventional 6-Minute Walk Test [Срок оценки: Baseline]
• Fatigue Effect During the Conventional 6-Minute Walk Test [Срок оценки: Baseline]
• Timed Up and Go Test (TUG) [Срок оценки: Baseline]
• 4-Meter Walk Test (4MWT) [Срок оценки: Baseline]
• Knee Extensor Muscle Strength [Срок оценки: Baseline]
• Participant Satisfaction [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Aged between 18 and 65 years,
• Asymptomatic, with no known or active cardiopulmonary, neurological, or musculoskeletal disease-related symptoms,
• Ability to ambulate independently without the use of an assistive device,
• Visual, auditory, and vestibular functions sufficient to tolerate mixed reality applications,
• Cognitive ability sufficient to understand and follow test instructions,
• Ability to read, understand, and follow instructions in Turkish,
• Willingness to participate voluntarily in the study and provision of written informed consent.

Критерии исключения

• Inability to safely complete walking tests due to serious musculoskeletal conditions (e.g., recent fracture, severe arthritis, advanced osteoarthritis, significant muscle or tendon injury),
• Presence of severe cardiopulmonary disease or any medical condition that may pose a risk during exercise testing (e.g., uncontrolled hypertension, heart failure, severe arrhythmia history, chronic obstructive pulmonary disease),
• High risk of balance loss or spatial disorientation in the mixed reality environment due to vestibular, visual, or auditory impairments,
• History of epilepsy or neurological conditions contraindicating mixed reality or head-mounted device use,
• Severe migraine, significant motion sickness history, or high risk of dizziness/nausea during mixed reality applications,
• Cognitive impairment or severe psychiatric conditions preventing understanding or completion of test procedures,
• Insufficient motivation or cooperation that may interfere with safe participation in the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitat — Konya

Публикации

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Идентификаторы

NCT: NCT07601009 · SelcukU_PT_6MWT_MR_ADAPTATION

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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