Validity and Reliability of Mixed Reality-Based Functional Mobility Tests in Type 2 Diabetes
2026年6月11日 更新者：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.
研究概览
研究类型
观察性的
注册 (估计的)
75
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mehmet K ALTUNOK, PHD(c) in PT
- 电话号码：+90 5558175133
- 邮箱：mehmetkaan.altunok@selcuk.edu.tr
学习地点
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Selcuklu
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Konya、Selcuklu、土耳其（türkiye）、42130
- 招聘中
- Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
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接触：
- Mehmet K ALTUNOK, PHD(c) in PT
- 电话号码：+90 5558175133
- 邮箱：mehmetkaan.altunok@selcuk.edu.tr
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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6-Minute Walk Test - Mixed Reality (6MW-MR)
大体时间：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)
大体时间：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)
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Participant Satisfaction
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Gülşah ÖZSOY, Assist. Prof. Dr.、Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- 学习椅：Zehra KORKUT, Assist. Prof. Dr.、Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- 学习椅：İsmail ÖZSOY, Assoc. Prof. Dr.、Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- 学习椅：Mehmet A GÜLER, PhD、Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- 学习椅：İhsan KODAK, Assist. Prof. Dr.、Kırşehir Ahi Evran University, School of Physical Therapy and Rehabilitation, Kırşehir, Türkiye
- 学习椅：Yasemin GEDİKLİ ERTÜRK, PhD (c) in PT、Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye
- 学习椅：Selma Ö ÇELİKDELEN, Assist. Prof. Dr.、Konya City Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月10日
初级完成 (估计的)
2026年12月30日
研究完成 (估计的)
2027年5月10日
研究注册日期
首次提交
2026年6月11日
首先提交符合 QC 标准的
2026年6月11日
首次发布 (实际的)
2026年6月16日
研究记录更新
最后更新发布 (实际的)
2026年6月16日
上次提交的符合 QC 标准的更新
2026年6月11日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.