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Recruiting NCT07654439

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

Observational Overweight and Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mixed Reality-Based Functional Mobility and Performance Assessment.
Who it may be relevant to
Registry conditions: Overweight and Obesity. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Mixed 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

Primary outcome measures

  • Timed Up and Go Test - Mixed Reality (TUG-MR) [Time frame: Baseline and 1-week follow-up]
  • 4-Meter Walk Test - Mixed Reality (4MW-MR) [Time frame: Baseline and 1-week follow-up]
  • Five-Repetition Sit-to-Stand Test - Mixed Reality (5xSTS-MR) [Time frame: Baseline and 1-week follow-up]
Secondary outcome measures (6)
  • Timed Up and Go Test - Conventional [Time frame: Baseline]
  • 4-Meter Walk Test - Conventional [Time frame: Baseline]
  • Five-Repetition Sit-to-Stand Test - Conventional [Time frame: Baseline]
  • Knee Extensor Muscle Strength [Time frame: Baseline]
  • Handgrip Strength [Time frame: Baseline]
  • Participant Satisfaction [Time frame: Baseline]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitat — Konya

Publications

  • Sousa-Santos AR, Amaral TF. Differences in handgrip strength protocols to identify sarcopenia and frailty - a systematic review. BMC Geriatr. 2017 Oct 16;17(1):238. doi: 10.1186/s12877-017-0625-y. PMID 29037155
  • Saunders S, Reid J, Mehdipour A, D'Amore C, Kuspinar A, Richardson J, Beauchamp M. Virtual Assessment Protocols for Timed-Up-and-Go, 5-Repetition Chair Rise, and 1-Minute Sit-to-Stand Tests in Community-Dwelling Older Adults: Investigating Feasibility, Reliability, and Validity. Arch Phys Med Rehabil. 2025 Jun;106(6):926-933. doi: 10.1016/j.apmr.2024.11.011. Epub 2024 Nov 28. PMID 39615825
  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x. PMID 1991946
  • Muhla F, Clanche F, Duclos K, Meyer P, Maiaux S, Colnat-Coulbois S, Gauchard GC. Impact of using immersive virtual reality over time and steps in the Timed Up and Go test in elderly people. PLoS One. 2020 Mar 13;15(3):e0229594. doi: 10.1371/journal.pone.0229594. eCollection 2020. PMID 32168361
  • Maggio M, Ceda GP, Ticinesi A, De Vita F, Gelmini G, Costantino C, Meschi T, Kressig RW, Cesari M, Fabi M, Lauretani F. Instrumental and Non-Instrumental Evaluation of 4-Meter Walking Speed in Older Individuals. PLoS One. 2016 Apr 14;11(4):e0153583. doi: 10.1371/journal.pone.0153583. eCollection 2016. PMID 27077744
  • Griswold D, Rockwell K, Killa C, Maurer M, Landgraff N, Learman K. Establishing the reliability and concurrent validity of physical performance tests using virtual reality equipment for community-dwelling healthy elders. Disabil Rehabil. 2015;37(12):1097-101. doi: 10.3109/09638288.2014.952451. Epub 2014 Aug 25. PMID 25151998
  • Greco F, Tarsitano MG, Cosco LF, Quinzi F, Folino K, Spadafora M, Afzal M, Segura-Garcia C, Maurotti S, Pujia R, Pujia A, Buono P, Emerenziani GP. The Effects of Online Home-Based Pilates Combined with Diet on Body Composition in Women Affected by Obesity: A Preliminary Study. Nutrients. 2024 Mar 21;16(6):902. doi: 10.3390/nu16060902. PMID 38542813
  • Chen Y, Guan B, Zhang Y, Lee SC, Liu JY, Li S, Liu M, Zhang X, Ming WK. Acceptability of and Willingness to Use Virtual Reality Exergames for Weight Loss Among Young Adults With Overweight or Obesity in China: Qualitative Study. JMIR Serious Games. 2025 May 1;13:e66998. doi: 10.2196/66998. PMID 40311124

Identifiers

NCT: NCT07654439 · SelcukU_PT_OBESITY_MR_ADAP1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗