Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

15 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

200

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
6-Minute Walk Distance - Mixed Reality (MR-6MWT)
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
6-Minute Walk Distance - Conventional 6-Minute Walk Test
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Selcuk University

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 februari 2026

Primaire voltooiing (Geschat)

30 november 2026

Studie voltooiing (Geschat)

1 januari 2027

Studieregistratiedata

Eerst ingediend

15 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 mei 2026

Eerst geplaatst (Werkelijk)

22 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

15 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • SelcukU_PT_6MWT_MR_ADAPTATION

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren