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

NCT07654439 | Recruiting

• 1 other identifier: SelcukU_PT_OBESITY_MR_ADAP1
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and 1-week follow-up

• 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.

  Baseline and 1-week follow-up

• 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.

  Baseline and 1-week follow-up

Secondary Outcomes (6)

• Timed Up and Go Test - Conventional

  Baseline

• 4-Meter Walk Test - Conventional

  Baseline

• Five-Repetition Sit-to-Stand Test - Conventional

  Baseline

• Knee Extensor Muscle Strength

  Baseline

• Handgrip Strength

  Baseline

Study Arms (1)

Overweight and Obese Individuals

Adults with overweight or obesity (BMI ≥25 kg/m²) who will undergo conventional and mixed reality-based assessments of functional mobility and performance, including the Timed Up and Go Test, 4-Meter Walk Test, and Five-Repetition Sit-to-Stand Test. Additional assessments of knee extensor muscle strength and handgrip strength will be performed to evaluate convergent validity.

Other: Mixed Reality-Based Functional Mobility and Performance Assessment

Interventions

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.

Overweight and Obese Individuals

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

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

Konya, Selcuklu, 42130, Turkey (Türkiye)

RECRUITING

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Cesari M, Kritchevsky SB, Newman AB, Simonsick EM, Harris TB, Penninx BW, Brach JS, Tylavsky FA, Satterfield S, Bauer DC, Rubin SM, Visser M, Pahor M; Health, Aging and Body Composition Study. Added value of physical performance measures in predicting adverse health-related events: results from the Health, Aging And Body Composition Study. J Am Geriatr Soc. 2009 Feb;57(2):251-9. doi: 10.1111/j.1532-5415.2008.02126.x.

  PMID: 19207142 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• İsmail ÖZSOY, Assoc. Prof. Dr.

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

  STUDY CHAIR

• Zehra KORKUT, Assist. Prof. Dr.

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

  STUDY CHAIR

• Gülşah ÖZSOY, Assist. Prof. Dr.

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

  STUDY CHAIR

• Mehmet A GÜLER, PhD in PT

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

  STUDY CHAIR

• Yasemin GEDİKLİ ERTÜRK, PhD (c) in PT

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

  STUDY CHAIR

• İhsan KODAK, Assist. Prof. Dr.

  Kırşehir Ahi Evran University, School of Physical Therapy and Rehabilitation, Kırşehir, Türkiye

  STUDY CHAIR

• Selma Ö ÇELİKDELEN, Assist. Prof. Dr.

  Konya City Hospital

  STUDY CHAIR

Central Study Contacts

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

5558175133; mehmetkaan.altunok@selcuk.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 10, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)