- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07654439
Validity and Reliability of Mixed Reality-Based Performance Tests in Overweight and Obese Adults
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.
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Mehmet K ALTUNOK, PHD(c) in PT
- Telefonní číslo: +90 5558175133
- E-mail: mehmetkaan.altunok@selcuk.edu.tr
Studijní místa
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Selcuklu
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Konya, Selcuklu, Turecko (Türkiye), 42130
- Nábor
- Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
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Kontakt:
- Mehmet K ALTUNOK, PHD(c) in PT
- Telefonní číslo: +90 5558175133
- E-mail: mehmetkaan.altunok@selcuk.edu.tr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Five-Repetition Sit-to-Stand Test - Mixed Reality (5xSTS-MR)
Časové okno: Baseline and 1-week follow-up
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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.
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Baseline and 1-week follow-up
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Timed Up and Go Test - Mixed Reality (TUG-MR)
Časové okno: Baseline and 1-week follow-up
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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.
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Baseline and 1-week follow-up
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4-Meter Walk Test - Mixed Reality (4MW-MR)
Časové okno: Baseline and 1-week follow-up
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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.
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Baseline and 1-week follow-up
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Participant Satisfaction
Časové okno: Baseline
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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.
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Baseline
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Timed Up and Go Test - Conventional
Časové okno: Baseline
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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.
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Baseline
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Five-Repetition Sit-to-Stand Test - Conventional
Časové okno: Baseline
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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.
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Baseline
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Knee Extensor Muscle Strength
Časové okno: Baseline
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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.
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Baseline
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Handgrip Strength
Časové okno: Baseline
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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.
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Baseline
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4-Meter Walk Test - Conventional
Časové okno: Baseline
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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.
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Baseline
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Gülşah ÖZSOY, Assist. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Studijní židle: Zehra KORKUT, Assist. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Studijní židle: İsmail ÖZSOY, Assoc. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Studijní židle: İhsan KODAK, Assist. Prof. Dr., Kırşehir Ahi Evran University, School of Physical Therapy and Rehabilitation, Kırşehir, Türkiye
- Studijní židle: Yasemin GEDİKLİ ERTÜRK, PhD (c) in PT, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Studijní židle: Selma Ö ÇELİKDELEN, Assist. Prof. Dr., Konya City Hospital
- Studijní židle: Mehmet A GÜLER, PhD in PT, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SelcukU_PT_OBESITY_MR_ADAP1
Plán pro data jednotlivých účastníků (IPD)
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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