Validity and Reliability of a Mixed Reality-Based 6-Minute Walk Test
15. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Podmínky
Intervence / Léčba
Typ studie
Pozorovací
Zápis (Odhadovaný)
200
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Mehmet K ALTUNOK, PHD(c) in PT
- Telefonní číslo: +90 5558175133
- E-mail: mehmetkaan.altunok@selcuk.edu.tr
Studijní místa
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Selcuklu
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Konya, Selcuklu, Turecko (Türkiye), 42130
- Nábor
- Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
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Kontakt:
- Mehmet K ALTUNOK, PHD(c) in PT
- Telefonní číslo: +90 5558175133
- E-mail: mehmetkaan.altunok@selcuk.edu.tr
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ano
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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6-Minute Walk Distance - Mixed Reality (MR-6MWT)
Časové okno: Baseline and 1-week follow-up
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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.
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Baseline and 1-week follow-up
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Fatigue Effect During the Mixed Reality-Based 6-Minute Walk Test
Časové okno: Baseline and 1-week follow-up
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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.
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Baseline and 1-week follow-up
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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6-Minute Walk Distance - Conventional 6-Minute Walk Test
Časové okno: Baseline
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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.
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Baseline
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Fatigue Effect During the Conventional 6-Minute Walk Test
Časové okno: Baseline
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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.
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Baseline
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Timed Up and Go Test (TUG)
Časové okno: Baseline
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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.
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Baseline
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4-Meter Walk Test (4MWT)
Časové okno: Baseline
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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.
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Baseline
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Knee Extensor Muscle Strength
Časové okno: Baseline
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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.
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Baseline
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Participant Satisfaction
Časové okno: Baseline
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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.
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Baseline
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Studijní židle: Gülşah ÖZSOY, Assist. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Studijní židle: Zehra KORKUT, Assist. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Studijní židle: İsmail ÖZSOY, Assoc. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Studijní židle: Mehmet A GÜLER, PhD, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Studijní židle: Yasemin GEDİKLİ ERTÜRK, MSc. in PT, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Studijní židle: Murat T İNANÇ, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Studijní židle: İhsan KODAK, Assist. Prof. Dr., Kırşehir Ahi Evran University, School of Physical Therapy and Rehabilitation, Kırşehir, Türkiye
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- Van Geel F, Veldkamp R, Severijns D, Dalgas U, Feys P. Day-to-day reliability, agreement and discriminative validity of measuring walking-related performance fatigability in persons with multiple sclerosis. Mult Scler. 2020 Nov;26(13):1785-1789. doi: 10.1177/1352458519872465. Epub 2019 Sep 9.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. února 2026
Primární dokončení (Odhadovaný)
30. listopadu 2026
Dokončení studie (Odhadovaný)
1. ledna 2027
Termíny zápisu do studia
První předloženo
15. května 2026
První předloženo, které splnilo kritéria kontroly kvality
15. května 2026
První zveřejněno (Aktuální)
22. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
22. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
15. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- SelcukU_PT_6MWT_MR_ADAPTATION
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Mixed Reality-Based 6-Minute Walk Test Assessment
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Spyridon FortisAmerican Thoracic SocietyNáborPlicní onemocnění, chronická obstrukčníSpojené státy