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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07654439

Enrollment

119

Registered

2026-06-17

Start date

2026-06-10

Completion date

2027-05-10

Last updated

2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

Overweight, Obesity, Mixed Reality, 6-Minute Walk Test, Timed Up and Go Test, Five-Repetition Sit-to-Stand Test, Functional Performance, Validity, Reliability

Brief summary

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.

Interventions

OTHERMixed 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.

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
Timed Up and Go Test - Conventional	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.
4-Meter Walk Test - Conventional	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.
Five-Repetition Sit-to-Stand Test - Conventional	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.
Knee Extensor Muscle Strength	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.
Handgrip Strength	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.
Participant Satisfaction	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.

Countries

Turkey (Türkiye)