NCT07649967Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 75 (estimated)
- First submitted
- 11 Jun 2026
- Start date
- 10 Jun 2026
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Selcuk University
- Diseases
- Type 2 diabetes
- NCT number
- NCT07649967
What you commit to
- Study type: Observational
- Planned participants: 75
- From 10 Jun 2026 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Myocardial infarction within the previous 6 months,
Other illness
- 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,
- Unstable ischemic heart disease or uncontrolled angina,
- Presence of severe musculoskeletal, neurological, or vestibular disorders that may interfere with safe test performance,
Other
- Presence of proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy,
- Resting blood pressure greater than 160/100 mmHg,
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Coordinator of this site? Confirm its status | Konya | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.