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NCT Number: NCT07601009

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

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.

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Key information

Conditions

Mixed Reality Asymptomatic

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

[email protected]

5558175133 ext. +90

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Mixed Reality-Based 6-Minute Walk Test Assessment

Other

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 be repeated one week later to evaluate test-retest reliability and compared with the conventional 6-Minute Walk Test to assess criterion validity.

Primary outcomes

  1. 6-Minute Walk Distance - Mixed Reality (MR-6MWT)

    Time frame: Baseline and 1-week follow-up

    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.

  2. Fatigue Effect During the Mixed Reality-Based 6-Minute Walk Test

    Time frame: Baseline and 1-week follow-up

    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.

Secondary outcomes

  1. 6-Minute Walk Distance - Conventional 6-Minute Walk Test

    Time frame: Baseline

    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.

  2. Fatigue Effect During the Conventional 6-Minute Walk Test

    Time frame: Baseline

    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.

  3. Timed Up and Go Test (TUG)

    Time frame: Baseline

    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.

  4. 4-Meter Walk Test (4MWT)

    Time frame: Baseline

    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.

  5. Knee Extensor Muscle Strength

    Time frame: Baseline

    Knee extensor muscle strength will be measured using a handheld digital dynamometer. Maximum voluntary contraction values will be recorded, with higher values indicating greater muscle strength. Outcomes will be analyzed for convergent validity with MR-6MWT parameters.

  6. Participant Satisfaction

    Time frame: Baseline

    Participant satisfaction with conventional and mixed reality-based assessments will be evaluated using a 10-point visual analog scale ranging from 1 to 10, with higher scores indicating greater satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

[email protected]

5558175133 ext. +90

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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