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Validity and Reliability of Mixed Reality-Based Performance Tests in Overweight and Obese Adults

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

Validity and Reliability of the Mixed Reality Adaptation of Performance Tests in Overweight and Obese Individuals

This study aims to evaluate the validity and reliability of mixed reality (MR)-based adaptations of functional mobility and performance tests developed using the Meta Quest 3 platform by comparing their outcomes with conventional clinical assessments. Virtual and mixed reality technologies have gained increasing attention in clinical measurement due to their potential advantages, including assessment standardization, enhanced user interaction, and automated data collection.

Previous studies have demonstrated that virtual reality-based performance assessments can provide high reliability and show meaningful associations with traditional clinical measures across different populations. However, visual and vestibular stimuli, depth perception, and changes in movement strategies may cause performance in virtual environments to differ from performance in conventional settings. Therefore, the validity and reliability of each virtual or mixed reality adaptation should be established within the target population.

Overweight and obese individuals exhibit biomechanical and physiological characteristics that may affect balance, gait mechanics, joint loading, and physical performance. Consequently, measurement properties established in other populations cannot be assumed to apply directly to overweight and obese individuals. In addition, factors related to head-mounted displays and motion-tracking systems may influence assessment outcomes.

The purpose of this study is to evaluate the concurrent validity and test-retest reliability of mixed reality-based performance tests developed using the Meta Quest 3 platform. Measurement error parameters will also be determined to assess the clinical applicability of these MR-based assessments.

The findings of this study are expected to contribute to the development of safe, standardized, digital, and potentially remote assessment approaches for evaluating functional performance in overweight and obese individuals. Furthermore, the results may strengthen the scientific evidence supporting the use of digital assessment technologies in clinical practice.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

119

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 with overweight or obesity (BMI ≥25 kg/m²) who are able to ambulate independently and are eligible to participate in conventional and mixed reality-based functional mobility and performance assessments.

Beschreibung

Inclusion Criteria:

  • Body Mass Index (BMI) ≥ 25 kg/m² (overweight or obesity),
  • Ability to ambulate independently,
  • Aged between 18 and 65 years,
  • Willingness to participate voluntarily in the study and provide written informed consent.

Exclusion Criteria:

  • Use of anti-obesity medication,
  • Pregnancy,
  • Latent autoimmune diabetes in adults (LADA),
  • Chronic kidney disease,
  • Active or severe infections,
  • Liver failure,
  • Recent major cardiovascular events,
  • Unstable angina,
  • Heart failure classified as New York Heart Association (NYHA) Class III-IV,
  • Respiratory failure, cardiac arrhythmias, neoplastic diseases, or neurological or musculoskeletal disorders that may limit the safe performance of the tests.

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
Overweight and Obese Individuals
Adults with overweight or obesity (BMI ≥25 kg/m²) who will undergo conventional and mixed reality-based assessments of functional mobility and performance, including the Timed Up and Go Test, 4-Meter Walk 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 Mobility and Performance Assessment
Participants will perform mixed reality-based adaptations of the Timed Up and Go Test (TUG-MR), 4-Meter Walk Test (4MW-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
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
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 will be evaluated by comparison with the conventional Timed Up and Go Test, and reliability will be assessed using repeated measurements performed one week apart.
Baseline and 1-week follow-up
4-Meter Walk Test - Mixed Reality (4MW-MR)
Zeitfenster: Baseline and 1-week follow-up
Walking performance will be assessed using a mixed reality-based adaptation of the 4-Meter Walk Test. Walking speed will be calculated in meters per second (m/s), with higher values indicating better walking performance. Validity and reliability will be evaluated through comparison with the conventional 4-Meter Walk 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
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
4-Meter Walk Test - Conventional
Zeitfenster: Baseline
Walking speed will be assessed using the conventional 4-Meter Walk Test and will serve as a reference measure for validity analyses. Walking speed will be reported in meters per second (m/s), with higher values indicating better walking performance.
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: 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
  • Studienstuhl: Mehmet A GÜLER, PhD in PT, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

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

12. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Juni 2026

Zuerst gepostet (Tatsächlich)

17. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. 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_OBESITY_MR_ADAP1

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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