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NCT Number: NCT07654439

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

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

[email protected]

5558175133 ext. +90

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

    Time frame: 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.

  2. 4-Meter Walk Test - Mixed Reality (4MW-MR)

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Timed Up and Go Test - Conventional

    Time frame: 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.

  2. 4-Meter Walk Test - Conventional

    Time frame: 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.

  3. Five-Repetition Sit-to-Stand Test - Conventional

    Time frame: 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.

  4. Knee Extensor Muscle Strength

    Time frame: 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.

  5. Handgrip Strength

    Time frame: 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.

  6. Participant Satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

[email protected]

5558175133 ext. +90

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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