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Validity and Reliability of Mixed Reality-Based Functional Mobility Tests in Type 2 Diabetes

11. Juni 2026 aktualisiert von: Mehmet Kaan ALTUNOK, Selcuk University

Validity and Reliability of the Mixed Reality Adaptation of the 6-Minute Walk, Timed Up and Go, and Five-Repetition Sit-to-Stand Tests in Individuals With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus (T2DM) is a multifaceted metabolic disease associated not only with impaired glycemic control but also with reductions in muscle strength, balance, functional mobility, and walking performance. Individuals with T2DM may experience impairments in lower extremity function, postural control, and overall functional performance, which can negatively affect activities of daily living and quality of life. Therefore, the assessment of functional performance using reliable and valid methods is important for clinical monitoring and rehabilitation planning.

The 6-Minute Walk Test (6MWT), Timed Up and Go Test (TUG), and Five-Repetition Sit-to-Stand Test (5xSTS) are widely used clinical assessments for evaluating walking capacity, functional mobility, lower extremity function, and physical performance in individuals with T2DM. Previous studies have demonstrated that these tests provide reliable and clinically meaningful measurements in this population.

In recent years, virtual and mixed reality technologies have provided opportunities to conduct assessments in a more objective, standardized, and user-friendly manner. These technologies also offer important advantages, including real-time data collection, enhanced user interaction, and potential integration into future remote assessment applications. However, evidence regarding the measurement properties of mixed reality-based adaptations of commonly used functional performance tests in individuals with T2DM remains limited.

The aim of this study is to evaluate the validity and reliability of mixed reality-based adaptations of the 6-Minute Walk Test, Timed Up and Go Test, and Five-Repetition Sit-to-Stand Test developed using the Meta Quest 3 platform. In addition, convergent validity will be examined by investigating the relationships between outcomes obtained from the mixed reality-based assessments and measures of knee extensor muscle strength and handgrip strength.

The findings of this study are expected to contribute to the development of innovative, safe, standardized, and digital approaches for assessing functional performance in individuals with Type 2 Diabetes Mellitus. Furthermore, the results may provide a scientific foundation for future digital health applications and remote assessment strategies.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

75

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Türkei (türkiye)
    • Selcuklu
      • Konya, Selcuklu, Türkei (türkiye), 42130
        • Rekrutierung
        • Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adults aged 18-65 years diagnosed with Type 2 Diabetes Mellitus who are able to ambulate independently, are clinically stable, and are eligible to participate in conventional and mixed reality-based functional performance assessments.

Beschreibung

Inclusion Criteria:

  • Diagnosed with Type 2 Diabetes Mellitus by a physician,
  • Aged between 18 and 65 years,
  • Ability to ambulate independently without the use of an assistive device,
  • No participation in a structured exercise program within the previous 6 months,
  • Cognitive ability sufficient to understand and follow test instructions,
  • Visual, auditory, and vestibular functions sufficient to tolerate mixed reality applications,
  • Ability to read, understand, and follow instructions in Turkish,
  • Willingness to participate voluntarily in the study and provision of written informed consent.

Exclusion Criteria:

  • Presence of proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy,
  • Advanced peripheral neuropathy, active foot ulcer, Charcot foot, or significant sensory loss that may compromise safe test performance,
  • Presence of peripheral arterial disease,
  • Advanced renal failure, requirement for dialysis, or nephropathy that may compromise exercise safety,
  • Myocardial infarction within the previous 6 months,
  • Unstable ischemic heart disease or uncontrolled angina,
  • Resting blood pressure greater than 160/100 mmHg,
  • Presence of severe musculoskeletal, neurological, or vestibular disorders that may interfere with safe test performance,
  • High risk of balance loss or spatial disorientation in the mixed reality environment due to visual, auditory, or balance impairments,
  • Cognitive, behavioral, or compliance-related problems that may prevent completion of the study procedures.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Individuals with Type 2 Diabetes Mellitus
Adults aged 18-65 years diagnosed with Type 2 Diabetes Mellitus who will undergo conventional and mixed reality-based assessments of functional performance, including the 6-Minute Walk Test, Timed Up and Go Test, and Five-Repetition Sit-to-Stand Test. Additional assessments of knee extensor muscle strength and handgrip strength will be performed to evaluate convergent validity.
Sonstiges: Mixed Reality-Based Functional Performance Assessment
Participants will perform mixed reality-based adaptations of the 6-Minute Walk Test (6MW-MR), Timed Up and Go Test (TUG-MR), and Five-Repetition Sit-to-Stand Test (5xSTS-MR) developed for the Meta Quest 3 platform. The mixed reality environment digitally replicates the conventional test setups and provides standardized visual guidance while allowing participants to interact safely with the real environment. Test outcomes will be automatically recorded by the system and compared with conventional clinical assessments to evaluate validity. The mixed reality-based tests will be repeated one week later to assess test-retest reliability.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
6-Minute Walk Test - Mixed Reality (6MW-MR)
Zeitfenster: Baseline and 1-week follow-up
Functional exercise capacity and walking endurance will be assessed using a mixed reality-based adaptation of the 6-Minute Walk Test. Walking distance will be recorded in meters, with greater distances indicating better performance. Validity will be evaluated by comparison with the conventional 6-Minute Walk Test, and reliability will be assessed using repeated measurements performed one week apart.
Baseline and 1-week follow-up
Timed Up and Go Test - Mixed Reality (TUG-MR)
Zeitfenster: Baseline and 1-week follow-up
Functional mobility will be assessed using a mixed reality-based adaptation of the Timed Up and Go Test. Test completion time will be recorded in seconds, with shorter times indicating better functional mobility. Validity and reliability will be evaluated through comparison with the conventional Timed Up and Go Test and repeated measurements.
Baseline and 1-week follow-up
Five-Repetition Sit-to-Stand Test - Mixed Reality (5xSTS-MR)
Zeitfenster: Baseline and 1-week follow-up
Lower extremity functional performance will be assessed using a mixed reality-based adaptation of the Five-Repetition Sit-to-Stand Test. Test duration will be recorded in seconds, with shorter times indicating better performance. Validity and reliability will be evaluated through comparison with the conventional Five-Repetition Sit-to-Stand Test and repeated measurements.
Baseline and 1-week follow-up

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Participant Satisfaction
Zeitfenster: 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
6-Minute Walk Test - Conventional
Zeitfenster: Baseline
Walking distance measured during the conventional 6-Minute Walk Test will be used as a reference measure for concurrent validity analyses. Greater distances indicate better functional exercise capacity.
Baseline
Timed Up and Go Test - Conventional
Zeitfenster: Baseline
The conventional Timed Up and Go Test will be administered to assess functional mobility and will serve as a reference measure for validity analyses. Test completion time will be recorded in seconds, with shorter times indicating better functional mobility.
Baseline
Five-Repetition Sit-to-Stand Test - Conventional
Zeitfenster: Baseline
The conventional Five-Repetition Sit-to-Stand Test will be used as a reference measure for validity analyses. Test completion time will be recorded in seconds, with shorter times indicating better lower extremity functional performance.
Baseline
Knee Extensor Muscle Strength
Zeitfenster: 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 mixed reality-based test results.
Baseline
Handgrip Strength
Zeitfenster: Baseline
Handgrip strength will be assessed using a hand dynamometer. The highest value obtained from repeated trials will be recorded, with higher values indicating greater muscle strength. Outcomes will be analyzed for convergent validity with mixed reality-based test results.
Baseline

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Selcuk University

Ermittler

  • Studienstuhl: Gülşah ÖZSOY, Assist. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Studienstuhl: Zehra KORKUT, Assist. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Studienstuhl: İsmail ÖZSOY, Assoc. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Studienstuhl: Mehmet A GÜLER, PhD, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Studienstuhl: İhsan KODAK, Assist. Prof. Dr., Kırşehir Ahi Evran University, School of Physical Therapy and Rehabilitation, Kırşehir, Türkiye
  • Studienstuhl: Yasemin GEDİKLİ ERTÜRK, PhD (c) in PT, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
  • Studienstuhl: Selma Ö ÇELİKDELEN, Assist. Prof. Dr., Konya City Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. Juni 2026

Primärer Abschluss (Geschätzt)

30. Dezember 2026

Studienabschluss (Geschätzt)

10. Mai 2027

Studienanmeldedaten

Zuerst eingereicht

11. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SelcukU_PT_DM_MR_ADAPTATİON_1

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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