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

NCT07601009 | Recruiting

• 1 other identifier: SelcukU_PT_6MWT_MR_ADAPTATION
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mixed Reality; Asymptomatic

Keywords

6-Minute Walk Test; Mixed Reality; Functional Exercise Capacity; Walking Endurance; Validity; Reliability; Asymptomatic Adults; Distance Walked Index; Fatigue Effect; Digital Assessment

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 1-week follow-up

• 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.

  Baseline and 1-week follow-up

Secondary Outcomes (6)

• 6-Minute Walk Distance - Conventional 6-Minute Walk Test

  Baseline

• Fatigue Effect During the Conventional 6-Minute Walk Test

  Baseline

• Timed Up and Go Test (TUG)

  Baseline

• 4-Meter Walk Test (4MWT)

  Baseline

• Knee Extensor Muscle Strength

  Baseline

Study Arms (1)

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

Interventions

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.

Asymptomatic Adults

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

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

Konya, Selcuklu, 42130, Turkey (Türkiye)

RECRUITING

Related Publications (11)

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  PMID: 31496362 BACKGROUND

• Ramari C, Hvid LG, David AC, Dalgas U. The importance of lower-extremity muscle strength for lower-limb functional capacity in multiple sclerosis: Systematic review. Ann Phys Rehabil Med. 2020 Mar;63(2):123-137. doi: 10.1016/j.rehab.2019.11.005. Epub 2019 Dec 6.

  PMID: 31816449 BACKGROUND

• Maden C, Gozacan Karabulut D, Bagci B. Validity and reliability of an immersive virtual reality adaptation of the 6-minute pegboard and ring test. Hand Surg Rehabil. 2025 Feb;44(1):101981. doi: 10.1016/j.hansur.2024.101981. Epub 2024 Oct 30.

  PMID: 39486588 BACKGROUND

• Leone C, Severijns D, Dolezalova V, Baert I, Dalgas U, Romberg A, Bethoux F, Gebara B, Santoyo Medina C, Maamagi H, Rasova K, Maertens de Noordhout B, Knuts K, Skjerbaek A, Jensen E, Wagner JM, Feys P. Prevalence of Walking-Related Motor Fatigue in Persons With Multiple Sclerosis: Decline in Walking Distance Induced by the 6-Minute Walk Test. Neurorehabil Neural Repair. 2016 May;30(4):373-83. doi: 10.1177/1545968315597070. Epub 2015 Jul 27.

  PMID: 26216790 BACKGROUND

• Hwang R, Morris NR, Mandrusiak A, Mudge A, Suna J, Adsett J, Russell T. Timed Up and Go Test: A Reliable and Valid Test in Patients With Chronic Heart Failure. J Card Fail. 2016 Aug;22(8):646-50. doi: 10.1016/j.cardfail.2015.09.018. Epub 2015 Oct 9.

  PMID: 26456063 BACKGROUND

• Grimpampi E, Oesen S, Halper B, Hofmann M, Wessner B, Mazza C. Reliability of gait variability assessment in older individuals during a six-minute walk test. J Biomech. 2015 Nov 26;48(15):4185-4189. doi: 10.1016/j.jbiomech.2015.10.008. Epub 2015 Oct 20.

  PMID: 26515246 BACKGROUND

• Gautschi OP, Smoll NR, Corniola MV, Joswig H, Chau I, Hildebrandt G, Schaller K, Stienen MN. Validity and Reliability of a Measurement of Objective Functional Impairment in Lumbar Degenerative Disc Disease: The Timed Up and Go (TUG) Test. Neurosurgery. 2016 Aug;79(2):270-8. doi: 10.1227/NEU.0000000000001195.

  PMID: 26702840 BACKGROUND

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

• Christopher A, Kraft E, Olenick H, Kiesling R, Doty A. The reliability and validity of the Timed Up and Go as a clinical tool in individuals with and without disabilities across a lifespan: a systematic review. Disabil Rehabil. 2021 Jun;43(13):1799-1813. doi: 10.1080/09638288.2019.1682066. Epub 2019 Oct 26.

  PMID: 31656104 BACKGROUND

• Bohannon RW, Wang YC. Four-Meter Gait Speed: Normative Values and Reliability Determined for Adults Participating in the NIH Toolbox Study. Arch Phys Med Rehabil. 2019 Mar;100(3):509-513. doi: 10.1016/j.apmr.2018.06.031. Epub 2018 Aug 6.

  PMID: 30092204 BACKGROUND

• Bayram GA, Sahin GE, Yilmaz G, Tayboga UI, Celik AG, Yildirim Y, Saribas PK, Tarakci D. Integration of the wingate anaerobic test into a virtual reality- based evaluation system. BMC Sports Sci Med Rehabil. 2025 Jul 2;17(1):163. doi: 10.1186/s13102-025-01220-4.

  PMID: 40605090 BACKGROUND

Study Officials

• İsmail ÖZSOY, Assoc. 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

• Gülşah ÖZSOY, Assist. 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

• İhsan KODAK, Assist. Prof. Dr.

  Kırşehir Ahi Evran University, School of Physical Therapy and Rehabilitation, Kırşehir, Türkiye

  STUDY CHAIR

• Murat T İNANÇ

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

  STUDY CHAIR

Central Study Contacts

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

5558175133; mehmetkaan.altunok@selcuk.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)