Validity and Reliability of Mixed Reality-Based Mobility Tests in Multiple Sclerosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorSelcuk University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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),

Disqualifiers

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,

Trial population

Individuals with MS who applied to the Selçuk University Faculty of Medicine Hospital MS Living Center

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Clinical Assessments

    Other intervention

    Participants with multiple sclerosis will undergo EDSS assessment, functional mobility tests (TUG, 5xSTS, and T25FW; conventional and mixed reality-based), fatigue (MFIS), walking performance (MSWS-12), knee extensor muscle strength, handgrip strength, and participant satisfaction evaluations. Conventional tests will be performed prior to mixed reality-based assessments; MR-based tests will be conducted using the Meta Quest 3 and repeated one week later for test-retest reliability.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Individuals with Multiple Sclerosis1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Baseline and 1-week follow-up
2

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

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.

Time frame
Baseline and 1-week follow-up
3

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

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.

Time frame
Baseline and 1-week follow-up

Secondary outcomes

1

Timed Up and Go Test - Conventional

The conventional Timed Up and Go test will be administered to assess functional mobility and balance. This test is a valid and reliable clinical measure in individuals with multiple sclerosis.

Time frame
Baseline
2

Five-Repetition Sit-to-Stand Test - Conventional

The conventional Five-Repetition Sit-to-Stand test will be used to assess lower extremity muscle strength and functional mobility.

Time frame
Baseline
3

Timed 25-Foot Walk - Conventional

The conventional Timed 25-Foot Walk test will be administered to assess walking speed and mobility. This test is a component of the Multiple Sclerosis Functional Composite.

Time frame
Baseline
4

Expanded Disability Status Scale (EDSS)

This scale will be administered by a physician to determine the level of neurological disability in individuals with multiple sclerosis.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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