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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- 6-Minute Walk Test - Mixed Reality (6MW-MR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Mixed Reality-Based Functional Performance Assessment (Other)
结局指标
主要结局
6-Minute Walk Test - Mixed Reality (6MW-MR)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 6-Minute Walk Test - Conventional(Baseline)
- Timed Up and Go Test - Conventional(Baseline)
- Five-Repetition Sit-to-Stand Test - Conventional(Baseline)
- Knee Extensor Muscle Strength(Baseline)
- Handgrip Strength(Baseline)
- Participant Satisfaction(Baseline)
研究者
Mehmet Kaan ALTUNOK
Lecturer
Selcuk University