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临床试验/NCT07601009
NCT07601009招募中不适用

Validity and Reliability of a Mixed Reality-Based Adaptation of the 6-Minute Walk Test in Asymptomatic Adults

Selcuk University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
6-Minute Walk Distance - Mixed Reality (MR-6MWT)

研究概览

简要总结

The 6-Minute Walk Test (6MWT) is a widely used field test for assessing functional exercise capacity, walking endurance, and submaximal performance related to activities of daily living. However, in conventional applications, environmental conditions, observer-related differences, and standardization issues may lead to variability in measurement outcomes. In addition, evaluating only the total walking distance may not adequately reflect clinically important changes such as performance decline and walking-related motor fatigue occurring during the test.

For this reason, recent studies have recommended analyzing 6MWT data by dividing the test into minute-by-minute segments and using performance change metrics such as the Distance Walked Index (DWI). These approaches allow a more detailed evaluation of changes in walking performance throughout the test duration.

With advances in measurement technologies, mixed reality (MR)-based applications have attracted attention as a means of enabling more objective, standardized, and reproducible implementation of conventional clinical tests. MR technology allows users to maintain interaction with the real environment while receiving digital guidance and feedback, thereby providing a safe and standardized assessment setting. Nevertheless, evidence regarding the validity and reliability of mixed reality-based adaptations of the 6MWT, particularly in asymptomatic adults, remains limited.

The aim of this study is to evaluate the criterion validity and test-retest reliability of a mixed reality-based 6-Minute Walk Test (MR-6MWT) developed using the Meta Quest 3 and Unity platform. In addition, convergent validity will be examined by analyzing the relationships between total walking distance, minute-by-minute performance changes, fatigue effect (%), and outcomes of the 4-Meter Walk Test, Timed Up and Go Test, and knee extensor muscle strength.

The findings of this study are expected to contribute to the development of a more objective, standardized, and digitally based mixed reality adaptation of the 6MWT. Furthermore, the results may provide a scientific foundation for future remote assessment and digital monitoring applications.

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
是

入选标准

  • •Aged between 18 and 65 years,
  • •Asymptomatic, with no known or active cardiopulmonary, neurological, or musculoskeletal disease-related symptoms,
  • •Ability to ambulate independently without the use of an assistive device,
  • •Visual, auditory, and vestibular functions sufficient to tolerate mixed reality applications,
  • •Cognitive ability sufficient to understand and follow test instructions,
  • •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

  • •Inability to safely complete walking tests due to serious musculoskeletal conditions (e.g., recent fracture, severe arthritis, advanced osteoarthritis, significant muscle or tendon injury),
  • •Presence of severe cardiopulmonary disease or any medical condition that may pose a risk during exercise testing (e.g., uncontrolled hypertension, heart failure, severe arrhythmia history, chronic obstructive pulmonary disease),
  • •High risk of balance loss or spatial disorientation in the mixed reality environment due to vestibular, visual, or auditory impairments,
  • •History of epilepsy or neurological conditions contraindicating mixed reality or head-mounted device use,
  • •Severe migraine, significant motion sickness history, or high risk of dizziness/nausea during mixed reality applications,
  • •Cognitive impairment or severe psychiatric conditions preventing understanding or completion of test procedures,
  • •Insufficient motivation or cooperation that may interfere with safe participation in the study.

研究组 & 干预措施

Asymptomatic Adults

Asymptomatic adults aged 18-65 years undergoing conventional and mixed reality-based 6-Minute Walk Test assessments to evaluate criterion validity, test-retest reliability, fatigue-related performance changes, and associations with functional mobility and lower extremity muscle strength.

干预措施: Mixed Reality-Based 6-Minute Walk Test Assessment (Other)

结局指标

主要结局

6-Minute Walk Distance - Mixed Reality (MR-6MWT)

时间窗: Baseline and 1-week follow-up

Walking distance during the mixed reality-based 6-Minute Walk Test (MR-6MWT) will be measured in meters to assess functional exercise capacity and walking endurance. Criterion validity will be evaluated by comparison with the conventional 6-Minute Walk Test, and test-retest reliability will be assessed using repeated measurements performed one week apart.

Fatigue Effect During the Mixed Reality-Based 6-Minute Walk Test

时间窗: Baseline and 1-week follow-up

Fatigue effect (%) during the MR-6MWT will be calculated using the percentage change between walking speeds measured during the first minute (0-1 min) and the last minute (5-6 min) of the test. Higher values indicate greater performance decline during walking. Validity and reliability will be evaluated through repeated assessments and comparison with the conventional 6-Minute Walk Test.

次要结局

  • 6-Minute Walk Distance - Conventional 6-Minute Walk Test(Baseline)
  • Fatigue Effect During the Conventional 6-Minute Walk Test(Baseline)
  • Timed Up and Go Test (TUG)(Baseline)
  • 4-Meter Walk Test (4MWT)(Baseline)
  • Knee Extensor Muscle Strength(Baseline)
  • Participant Satisfaction(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Kaan ALTUNOK

Lecturer

Selcuk University

研究点 (1)

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