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临床试验/NCT07361965
NCT07361965尚未招募不适用

Validity and Reliability of the Mixed Reality-Based Adaptation of the Timed Up and Go, Five-Repetition Sit-to-Stand, and 25-Foot Walk Tests in Individuals With Multiple Sclerosis

Selcuk University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2026年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
75
试验地点
1
主要终点
Timed Up and Go Test - Mixed Reality (TUG-MR)

研究概览

简要总结

Multiple sclerosis (MS) is a demyelinating and neurodegenerative disease of the central nervous system, with common symptoms including muscle weakness, balance impairments, gait difficulties, and fatigue. These symptoms significantly affect individuals' functional mobility, independence, and quality of life. In individuals with MS, reduced lower extremity muscle strength leads to decreased walking speed and loss of balance, resulting in substantial limitations in activities of daily living.

Conventional clinical assessment tools, such as the Timed Up and Go (TUG), Five-Repetition Sit-to-Stand Test (5xSTS), and the Timed 25-Foot Walk (T25FW), have been widely used for many years to evaluate functional mobility in individuals with MS. However, these tests typically rely on unidimensional measurement parameters and may demonstrate subjective variability depending on the testing environment and the examiner's experience. Advances in measurement technologies now allow these clinical tests to be transformed into more objective, standardized, and interactive assessment tools.

Virtual reality (VR) provides a new perspective for the assessment of motor performance by enabling three-dimensional and interactive simulations of real-world scenarios. VR-based applications allow for the simultaneous evaluation of both motor and cognitive components while also increasing individuals' motivation and engagement. Previous studies have demonstrated that VR technology is effective in neurological rehabilitation, particularly in improving balance, walking speed, and functional mobility in the MS population. In contrast to VR, mixed reality (MR) is a technology that allows individuals to maintain interaction with the real environment while integrating virtual objects into the physical space.

The existing literature reveals a notable gap in research focusing on the validity and reliability of VR or MR-based functional tests in individuals with multiple sclerosis. However, no studies to date have investigated the adaptation of lower extremity functional tests (TUG, 5xSTS, and T25FW) to a mixed reality environment. Therefore, the primary rationale of this study is to evaluate the digital applicability of commonly used functional tests in individuals with MS on the Meta Quest 3 virtual reality platform and to determine the validity and reliability of these tests. Additionally, this study aims to examine the relationships between data obtained from the virtual tests and fatigue (Modified Fatigue Impact Scale, MFIS), walking performance (12-Item Multiple Sclerosis Walking Scale: MSWS-12), and knee extensor muscle strength in order to establish the convergent validity of this novel approach.

The findings of this study are expected to contribute to the development of an objective, standardized, safe, and innovative digital assessment tool for functional evaluation in individuals with multiple sclerosis. Furthermore, the results will strengthen the scientific foundation for remote monitoring of the rehabilitation process and for the development of personalized treatment programs.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • A confirmed diagnosis of multiple sclerosis (MS) established by a neurologist,
  • Not being in a relapse phase and having no MS relapse within the past 6 months,
  • Aged between 18 and 60 years,
  • Disease severity within an Expanded Disability Status Scale (EDSS) range of 1-5 (mild to moderate functional impairment),
  • Visual, auditory, and vestibular functions sufficient to tolerate mixed reality-based applications,
  • Adequate cognitive capacity to actively participate in the study (e.g., Mini-Mental State Examination score ≥ 24),
  • 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

  • Having experienced a multiple sclerosis relapse or undergone a change in MS-related treatment within the past 6 months,
  • Presence of severe musculoskeletal disorders (e.g., fracture, arthritis, advanced osteoarthritis, muscle tear) that may interfere with test performance,
  • Presence of severe cardiopulmonary disease (e.g., uncontrolled hypertension, heart failure, chronic obstructive pulmonary disease) or any medical condition that may pose a risk during exercise testing,
  • Risk of loss of balance or spatial disorientation in the mixed reality environment due to visual, vestibular, or auditory impairments,
  • Inability to perform functional tests due to severe spasticity, contractures, or orthopedic deformities,
  • History of epilepsy, migraine, or other neurological conditions that contraindicate the use of mixed reality or virtual reality devices,
  • Inability to understand test instructions due to cognitive impairment or severe mental health disorders (e.g., dementia, major depression, psychotic disorders),
  • Experiencing dizziness, nausea, or virtual reality-related symptoms (VR sickness) during testing,
  • Insufficient motivation or poor compliance that may hinder participation in the study.

研究组 & 干预措施

Individuals with Multiple Sclerosis

Individuals with multiple sclerosis aged 18-60 years.

干预措施: Clinical Assessments (Other)

结局指标

主要结局

Timed Up and Go Test - Mixed Reality (TUG-MR)

时间窗: Baseline and 1-week follow-up

This outcome measure will be used to assess functional mobility, balance, and lower extremity performance in individuals with multiple sclerosis using a mixed reality-based digital adaptation of the Timed Up and Go test. Test completion time will be automatically recorded by the system.

Five-Repetition Sit-to-Stand Test - Mixed Reality (5xSTS-MR)

时间窗: Baseline and 1-week follow-up

This outcome measure will be used to assess lower extremity muscle strength and functional mobility using a mixed reality-based adaptation of the Five-Repetition Sit-to-Stand test. Test duration will be automatically recorded.

Timed 25-Foot Walk - Mixed Reality (T25FW-MR)

时间窗: Baseline and 1-week follow-up

This outcome measure will be used to assess walking speed and functional mobility in individuals with multiple sclerosis using a mixed reality-based version of the Timed 25-Foot Walk test. Test time will be automatically recorded by the system.

次要结局

  • Timed Up and Go Test - Conventional(Baseline)
  • Five-Repetition Sit-to-Stand Test - Conventional(Baseline)
  • Timed 25-Foot Walk - Conventional(Baseline)
  • Expanded Disability Status Scale (EDSS)(Baseline)
  • Modified Fatigue Impact Scale (MFIS)(Baseline)
  • Multiple Sclerosis Walking Scale-12 (MSWS-12)(Baseline)
  • Knee Extensor Muscle Strength(Baseline)
  • Handgrip 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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