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

May 15, 2026 updated by: Mehmet Kaan ALTUNOK, Selcuk University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Selcuklu
      • Konya, Selcuklu, Turkey (Türkiye), 42130
        • Recruiting
        • Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asymptomatic Adults
Asymptomatic adults aged 18-65 years undergoing conventional and mixed reality-based 6-Minute Walk Test assessments to evaluate criterion validity, test-retest reliability, fatigue-related performance changes, and associations with functional mobility and lower extremity muscle strength.
Other: 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 be repeated one week later to evaluate test-retest reliability and compared with the conventional 6-Minute Walk Test to assess criterion validity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 1-week follow-up
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.
Baseline and 1-week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selcuk University

Investigators

  • Study Chair: Gülşah ÖZSOY, Assist. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Study Chair: Zehra KORKUT, Assist. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Study Chair: İsmail ÖZSOY, Assoc. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Study Chair: Mehmet A GÜLER, PhD, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Study Chair: Yasemin GEDİKLİ ERTÜRK, MSc. in PT, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Study Chair: Murat T İNANÇ, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Study Chair: İhsan KODAK, Assist. Prof. Dr., Kırşehir Ahi Evran University, School of Physical Therapy and Rehabilitation, Kırşehir, Türkiye

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

May 15, 2026

First Submitted That Met QC Criteria

May 15, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SelcukU_PT_6MWT_MR_ADAPTATION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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