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NCT Number: NCT07361965

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University Faculty of Medicine Hospital MS Life Center

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location contact

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

[email protected]

5558175133 ext. +90

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

clinical assessments

Other

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

  1. Timed Up and Go Test - Conventional

    Time frame: Baseline

    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.

  2. Five-Repetition Sit-to-Stand Test - Conventional

    Time frame: Baseline

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

  3. Timed 25-Foot Walk - Conventional

    Time frame: Baseline

    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.

  4. Expanded Disability Status Scale (EDSS)

    Time frame: Baseline

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

  5. Modified Fatigue Impact Scale (MFIS)

    Time frame: Baseline

    This scale will be used to assess the impact of fatigue on physical, cognitive, and psychosocial functioning in individuals with multiple sclerosis.

  6. Multiple Sclerosis Walking Scale-12 (MSWS-12)

    Time frame: Baseline

    This self-reported questionnaire will be used to assess walking performance and the impact of walking difficulties on daily life in individuals with multiple sclerosis.

  7. Knee Extensor Muscle Strength

    Time frame: Baseline

    Knee extensor muscle strength will be measured using a handheld digital dynamometer to assess lower extremity muscle strength.

  8. Handgrip Strength

    Time frame: Baseline

    Handgrip strength will be measured using a digital dynamometer to assess upper extremity muscle strength and overall muscular function.

  9. Participant Satisfaction

    Time frame: Baseline

    Participant satisfaction with conventional and mixed reality-based assessments will be evaluated using a 10-point numerical rating scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

[email protected]

5558175133 ext. +90

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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