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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07649967

Enrollment

Registered

2026-06-16

Start date

2026-06-10

Completion date

2027-05-10

Last updated

2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Type 2 Diabetes Mellitus, Mixed Reality, Functional Mobility, 6-Minute Walk Test, Timed Up and Go Test, Five-Repetition Sit-to-Stand Test, Validity, Reliability

Brief summary

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

OTHERMixed 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 clinical assessments to evaluate validity. The mixed reality-based tests will be repeated one week later to assess test-retest reliability.

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
6-Minute Walk Test - Conventional	Baseline	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.
Timed Up and Go Test - Conventional	Baseline	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.
Five-Repetition Sit-to-Stand Test - Conventional	Baseline	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.
Knee Extensor Muscle Strength	Baseline	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.
Handgrip Strength	Baseline	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.
Participant Satisfaction	Baseline	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.

Countries

Turkey (Türkiye)