Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07654439

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionOverweight and Obesity

Full registry criteria

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.

Treatments and study arms

Mixed Reality-Based Functional Mobility and Performance Assessment

Other

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.

Primary outcomes

Timed Up and Go Test - Mixed Reality (TUG-MR)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.

4-Meter Walk Test - Mixed Reality (4MW-MR)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.

Five-Repetition Sit-to-Stand Test - Mixed Reality (5xSTS-MR)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.

Study locations

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Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation🌐 Konya, Selcuklu, Turkey (Türkiye)

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Mehmet K ALTUNOK, PHD(c) in PTContact

Email · Call 5558175133