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Overweight and ObesityNCT07654439

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

An observational study of Overweight and Obesity, run by Selcuk University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overweight and Obesity
What is being tested?
Mixed Reality-Based Functional Mobility and Performance Assessment
How many people
119 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jun 2026to 10 May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Use of anti-obesity medication,
  • Pregnancy,
  • Latent autoimmune diabetes in adults (LADA),
  • Chronic kidney disease,
  • Active or severe infections,
  • Liver failure,
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mehmet K ALTUNOK, PHD(c) in PT contact

5558175133 ext. +90

mehmetkaan.altunok@selcuk.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    Konya, Selcuklu, 42130

    Mehmet K ALTUNOK, PHD(c) in PT, 5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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.

Being tested
Mixed Reality-Based Functional Mobility and Performance Assessment
Keywords
Overweight, Obesity, Mixed Reality, 6-Minute Walk Test, Timed Up and Go Test, Five-Repetition Sit-to-Stand Test, Functional Performance, Validity, Reliability
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mixed Reality-Based Functional Mobility and Performance AssessmentOther

    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 groups in NCT07654439
Study groupRoleWhat they receive
Overweight and Obese IndividualsAdults 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.
Receives: Other: Mixed Reality-Based Functional Mobility and Performance Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 1-week follow-up

  2. 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.

    Measured: Baseline and 1-week follow-up

  3. 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.

    Measured: Baseline and 1-week follow-up

Secondary outcomes (6)
  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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. Handgrip Strength

    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.

    Measured: Baseline

  6. Participant Satisfaction

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start10 Jun 2026
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion10 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
119 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07654439
Sponsor's protocol ID
SelcukU_PT_OBESITY_MR_ADAP1
Status last verified
Jun 2026
First submitted
12 Jun 2026
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 40311124
  • 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.

    PubMed 19207142

Questions about this trial

What is this clinical trial studying?

An observational study of Overweight and Obesity, run by Selcuk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehmet K ALTUNOK, PHD(c) in PT (5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed Up and Go Test - Mixed Reality (TUG-MR) (time frame: Baseline and 1-week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07654439, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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