Validity and Reliability of Mixed Reality-Based Functional Mobility Tests in Type 2 Diabetes

Official title

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

Overview

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.

Interventions

• Other Mixed Reality-Based Functional Performance Assessment
  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

Primary outcome measures

• 6-Minute Walk Test - Mixed Reality (6MW-MR) [Time frame: Baseline and 1-week follow-up]
• Timed Up and Go Test - Mixed Reality (TUG-MR) [Time frame: Baseline and 1-week follow-up]
• Five-Repetition Sit-to-Stand Test - Mixed Reality (5xSTS-MR) [Time frame: Baseline and 1-week follow-up]

Secondary outcome measures (6)

• 6-Minute Walk Test - Conventional [Time frame: Baseline]
• Timed Up and Go Test - Conventional [Time frame: Baseline]
• Five-Repetition Sit-to-Stand Test - Conventional [Time frame: Baseline]
• Knee Extensor Muscle Strength [Time frame: Baseline]
• Handgrip Strength [Time frame: Baseline]
• Participant Satisfaction [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Turkey (Türkiye) · 1 center

• Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitat — Konya

Publications

• 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. PMID 23806609
• 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
• 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
• 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. PMID 34207604
• 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. PMID 39486588
• 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. PMID 29673246
• 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. PMID 36456934
• 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

Identifiers

NCT: NCT07649967 · SelcukU_PT_DM_MR_ADAPTATİON_1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗