Validity and Reliability of Mixed Reality-Based Performance Tests in Overweight and Obese Adults
ConditionOverweight and Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSelcuk University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Use of anti-obesity medication,
Pregnancy,
Latent autoimmune diabetes in adults (LADA),
Chronic kidney disease,
Trial population
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.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Mixed Reality-Based Functional Mobility and Performance Assessment
Other interventionParticipants 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.
Treatment groups
119 Participants
are divided into 1 treatment groupGroup A: Overweight and Obese Individuals1 intervention
Trial outcomes
Primary outcomes
1
Timed Up and Go Test - Mixed Reality (TUG-MR)
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.
Time frame
Baseline and 1-week follow-up2
4-Meter Walk Test - Mixed Reality (4MW-MR)
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.
Time frame
Baseline and 1-week follow-up3
Five-Repetition Sit-to-Stand Test - Mixed Reality (5xSTS-MR)
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.
Time frame
Baseline and 1-week follow-upSecondary outcomes
1
Timed Up and Go Test - Conventional
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.
Time frame
Baseline2
4-Meter Walk Test - Conventional
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.
Time frame
Baseline3
Five-Repetition Sit-to-Stand Test - Conventional
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.
Time frame
Baseline4
Knee Extensor Muscle Strength
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov