Validity and Reliability of Mixed Reality-Based Functional Mobility Tests in Type 2 Diabetes
11 июня 2026 г. обновлено: Mehmet Kaan ALTUNOK, Selcuk University
Validity and Reliability of the Mixed Reality Adaptation of the 6-Minute Walk, Timed Up and Go, and Five-Repetition Sit-to-Stand Tests in Individuals With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM) is a multifaceted metabolic disease associated not only with impaired glycemic control but also with reductions in muscle strength, balance, functional mobility, and walking performance. Individuals with T2DM may experience impairments in lower extremity function, postural control, and overall functional performance, which can negatively affect activities of daily living and quality of life. Therefore, the assessment of functional performance using reliable and valid methods is important for clinical monitoring and rehabilitation planning.
The 6-Minute Walk Test (6MWT), Timed Up and Go Test (TUG), and Five-Repetition Sit-to-Stand Test (5xSTS) are widely used clinical assessments for evaluating walking capacity, functional mobility, lower extremity function, and physical performance in individuals with T2DM. Previous studies have demonstrated that these tests provide reliable and clinically meaningful measurements in this population.
In recent years, virtual and mixed reality technologies have provided opportunities to conduct assessments in a more objective, standardized, and user-friendly manner. These technologies also offer important advantages, including real-time data collection, enhanced user interaction, and potential integration into future remote assessment applications. However, evidence regarding the measurement properties of mixed reality-based adaptations of commonly used functional performance tests in individuals with T2DM remains limited.
The aim of this study is to evaluate the validity and reliability of mixed reality-based adaptations of the 6-Minute Walk Test, Timed Up and Go Test, and Five-Repetition Sit-to-Stand Test developed using the Meta Quest 3 platform. In addition, convergent validity will be examined by investigating the relationships between outcomes obtained from the mixed reality-based assessments and measures of knee extensor muscle strength and handgrip strength.
The findings of this study are expected to contribute to the development of innovative, safe, standardized, and digital approaches for assessing functional performance in individuals with Type 2 Diabetes Mellitus. Furthermore, the results may provide a scientific foundation for future digital health applications and remote assessment strategies.
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Тип исследования
Наблюдательный
Регистрация (Оцененный)
75
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Mehmet K ALTUNOK, PHD(c) in PT
- Номер телефона: +90 5558175133
- Электронная почта: mehmetkaan.altunok@selcuk.edu.tr
Места учебы
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Selcuklu
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Konya, Selcuklu, Турция (Туркие), 42130
- Рекрутинг
- Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
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Контакт:
- Mehmet K ALTUNOK, PHD(c) in PT
- Номер телефона: +90 5558175133
- Электронная почта: mehmetkaan.altunok@selcuk.edu.tr
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Невероятностная выборка
Исследуемая популяция
Adults aged 18-65 years diagnosed with Type 2 Diabetes Mellitus who are able to ambulate independently, are clinically stable, and are eligible to participate in conventional and mixed reality-based functional performance assessments.
Описание
Inclusion Criteria:
- Diagnosed with Type 2 Diabetes Mellitus by a physician,
- Aged between 18 and 65 years,
- Ability to ambulate independently without the use of an assistive device,
- No participation in a structured exercise program within the previous 6 months,
- Cognitive ability sufficient to understand and follow test instructions,
- Visual, auditory, and vestibular functions sufficient to tolerate mixed reality applications,
- Ability to read, understand, and follow instructions in Turkish,
- Willingness to participate voluntarily in the study and provision of written informed consent.
Exclusion Criteria:
- Presence of proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy,
- Advanced peripheral neuropathy, active foot ulcer, Charcot foot, or significant sensory loss that may compromise safe test performance,
- Presence of peripheral arterial disease,
- Advanced renal failure, requirement for dialysis, or nephropathy that may compromise exercise safety,
- Myocardial infarction within the previous 6 months,
- Unstable ischemic heart disease or uncontrolled angina,
- Resting blood pressure greater than 160/100 mmHg,
- Presence of severe musculoskeletal, neurological, or vestibular disorders that may interfere with safe test performance,
- High risk of balance loss or spatial disorientation in the mixed reality environment due to visual, auditory, or balance impairments,
- Cognitive, behavioral, or compliance-related problems that may prevent completion of the study procedures.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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Individuals with Type 2 Diabetes Mellitus
Adults aged 18-65 years diagnosed with Type 2 Diabetes Mellitus who will undergo conventional and mixed reality-based assessments of functional performance, including the 6-Minute Walk Test, Timed Up and Go 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 6-Minute Walk Test (6MW-MR), Timed Up and Go Test (TUG-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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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6-Minute Walk Test - Mixed Reality (6MW-MR)
Временное ограничение: Baseline and 1-week follow-up
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Functional exercise capacity and walking endurance will be assessed using a mixed reality-based adaptation of the 6-Minute Walk Test.
Walking distance will be recorded in meters, with greater distances indicating better performance.
Validity will be evaluated by comparison with the conventional 6-Minute Walk 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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Timed Up and Go Test - Mixed Reality (TUG-MR)
Временное ограничение: 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 and reliability will be evaluated through comparison with the conventional Timed Up and Go Test and repeated measurements.
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Baseline and 1-week follow-up
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Five-Repetition Sit-to-Stand Test - Mixed Reality (5xSTS-MR)
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Participant Satisfaction
Временное ограничение: 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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6-Minute Walk Test - Conventional
Временное ограничение: Baseline
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Walking distance measured during the conventional 6-Minute Walk Test will be used as a reference measure for concurrent validity analyses.
Greater distances indicate better functional exercise capacity.
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Baseline
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Timed Up and Go Test - Conventional
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Учебный стул: Gülşah ÖZSOY, Assist. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Учебный стул: Zehra KORKUT, Assist. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Учебный стул: İsmail ÖZSOY, Assoc. Prof. Dr., Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Учебный стул: Mehmet A GÜLER, PhD, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Учебный стул: İhsan KODAK, Assist. Prof. Dr., Kırşehir Ahi Evran University, School of Physical Therapy and Rehabilitation, Kırşehir, Türkiye
- Учебный стул: Yasemin GEDİKLİ ERTÜRK, PhD (c) in PT, Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- Учебный стул: Selma Ö ÇELİKDELEN, Assist. Prof. Dr., Konya City Hospital
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
- Munoz-Bermejo L, Adsuar JC, Mendoza-Munoz M, Barrios-Fernandez S, Garcia-Gordillo MA, Perez-Gomez J, Carlos-Vivas J. Test-Retest Reliability of Five Times Sit to Stand Test (FTSST) in Adults: A Systematic Review and Meta-Analysis. Biology (Basel). 2021 Jun 9;10(6):510. doi: 10.3390/biology10060510.
- Lee MC. Validity of the 6-minute walk test and step test for evaluation of cardio respiratory fitness in patients with type 2 diabetes mellitus. J Exerc Nutrition Biochem. 2018 Mar 30;22(1):49-55. doi: 10.20463/jenb.2018.0008.
- 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.
- Goldberg A, Chavis M, Watkins J, Wilson T. The five-times-sit-to-stand test: validity, reliability and detectable change in older females. Aging Clin Exp Res. 2012 Aug;24(4):339-44. doi: 10.1007/BF03325265.
- ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Maden C, Gozacan Karabulut D, Bagci B. Validity and reliability of an immersive virtual reality adaptation of the 6-minute pegboard and ring test. Hand Surg Rehabil. 2025 Feb;44(1):101981. doi: 10.1016/j.hansur.2024.101981. Epub 2024 Oct 30.
- Bayram GA, Sahin GE, Yilmaz G, Tayboga UI, Celik AG, Yildirim Y, Saribas PK, Tarakci D. Integration of the wingate anaerobic test into a virtual reality- based evaluation system. BMC Sports Sci Med Rehabil. 2025 Jul 2;17(1):163. doi: 10.1186/s13102-025-01220-4.
- Vaz MM, Costa GC, Reis JG, Junior WM, Albuquerque de Paula FJ, Abreu DC. Postural control and functional strength in patients with type 2 diabetes mellitus with and without peripheral neuropathy. Arch Phys Med Rehabil. 2013 Dec;94(12):2465-2470. doi: 10.1016/j.apmr.2013.06.007. Epub 2013 Jun 24.
- Kowall B. Lower body muscle strength, dynapenic obesity and risk of type 2 diabetes -longitudinal results on the chair-stand test from the Survey of Health, Ageing and Retirement in Europe (SHARE). BMC Geriatr. 2022 Dec 1;22(1):924. doi: 10.1186/s12877-022-03647-7.
- Dominguez-Munoz FJ, Adsuar JC, Villafaina S, Garcia-Gordillo MA, Hernandez-Mocholi MA, Collado-Mateo D, Gusi N. Test-Retest Reliability of Vibration Perception Threshold Test in People with Type 2 Diabetes Mellitus. Int J Environ Res Public Health. 2020 Mar 9;17(5):1773. doi: 10.3390/ijerph17051773.
- Alfonso-Rosa RM, Del Pozo-Cruz B, Del Pozo-Cruz J, Sanudo B, Rogers ME. Test-retest reliability and minimal detectable change scores for fitness assessment in older adults with type 2 diabetes. Rehabil Nurs. 2014 Sep-Oct;39(5):260-8. doi: 10.1002/rnj.111. Epub 2013 Jun 18.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
10 июня 2026 г.
Первичное завершение (Оцененный)
30 декабря 2026 г.
Завершение исследования (Оцененный)
10 мая 2027 г.
Даты регистрации исследования
Первый отправленный
11 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
11 июня 2026 г.
Первый опубликованный (Действительный)
16 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
16 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
11 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- SelcukU_PT_DM_MR_ADAPTATİON_1
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .