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

NCT07649967 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2026-06-16

No results posted yet for this study

Summary

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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

OTHER

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.

Sponsors & Collaborators

  • Selcuk University

    lead OTHER

Principal Investigators

  • İsmail ÖZSOY, Assoc. Prof. Dr. · Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  • Zehra KORKUT, Assist. Prof. Dr. · Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  • Gülşah ÖZSOY, Assist. Prof. Dr. · Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  • Mehmet A GÜLER, PhD · Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  • Yasemin GEDİKLİ ERTÜRK, PhD (c) in PT · Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  • İhsan KODAK, Assist. Prof. Dr. · Kırşehir Ahi Evran University, School of Physical Therapy and Rehabilitation, Kırşehir, Türkiye

  • Selma Ö ÇELİKDELEN, Assist. Prof. Dr. · Konya City Hospital

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-10
Primary Completion
2026-12-30
Completion
2027-05-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07649967 on ClinicalTrials.gov