Validity and Reliability of a Mixed Reality-Based 6-Minute Walk Test
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSelcuk University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial population
Asymptomatic adults aged 18-65 years who are able to ambulate independently and tolerate mixed reality applications, with no known cardiopulmonary, neurological, or musculoskeletal conditions affecting walking performance or functional exercise capacity.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Mixed Reality-Based 6-Minute Walk Test Assessment
Other interventionParticipants 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 be repeated one week later to evaluate test-retest reliability and compared with the conventional 6-Minute Walk Test to assess criterion validity.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Asymptomatic Adults1 intervention
Trial outcomes
Primary outcomes
1
6-Minute Walk Distance - Mixed Reality (MR-6MWT)
Walking distance during the mixed reality-based 6-Minute Walk Test (MR-6MWT) will be measured in meters to assess functional exercise capacity and walking endurance. Criterion validity will be evaluated by comparison with the conventional 6-Minute Walk Test, and test-retest reliability will be assessed using repeated measurements performed one week apart.
Time frame
Baseline and 1-week follow-up2
Fatigue Effect During the Mixed Reality-Based 6-Minute Walk Test
Fatigue effect (%) during the MR-6MWT will be calculated using the percentage change between walking speeds measured during the first minute (0-1 min) and the last minute (5-6 min) of the test. Higher values indicate greater performance decline during walking. Validity and reliability will be evaluated through repeated assessments and comparison with the conventional 6-Minute Walk Test.
Time frame
Baseline and 1-week follow-upSecondary outcomes
1
6-Minute Walk Distance - Conventional 6-Minute Walk Test
Walking distance measured during the conventional 6-Minute Walk Test will be used as a reference measure for criterion validity analyses. Greater walking distance indicates better functional exercise capacity.
Time frame
Baseline2
Fatigue Effect During the Conventional 6-Minute Walk Test
Fatigue effect (%) during the conventional 6-Minute Walk Test will be calculated from the percentage change in walking speed between the first and last minutes of the test. Higher values indicate greater walking-related performance decline.
Time frame
Baseline3
Timed Up and Go Test (TUG)
Functional mobility will be assessed using the Timed Up and Go test. Test completion time will be recorded in seconds, with shorter times indicating better functional mobility. TUG outcomes will be analyzed for convergent validity with MR-6MWT parameters.
Time frame
Baseline4
4-Meter Walk Test (4MWT)
Walking speed will be assessed using the 4-Meter Walk Test. Walking speed will be calculated in meters per second (m/s), with higher values indicating better walking performance. Results will be analyzed for convergent validity with MR-6MWT outcomes.
Time frame
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Source ClinicalTrials.gov