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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07361965

Enrollment

Registered

2026-01-23

Start date

2026-02-02

Completion date

2026-07-30

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Mixed Reality

Keywords

Multiple Sclerosis, Mixed Reality, Functional Mobility, Validity, Reliability, Digital Assessment

Brief summary

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.

Interventions

OTHERClinical Assessments

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.

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Timed Up and Go Test - Mixed Reality (TUG-MR)	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)	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)	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

Measure	Time frame	Description
Timed Up and Go Test - Conventional	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.
Five-Repetition Sit-to-Stand Test - Conventional	Baseline	The conventional Five-Repetition Sit-to-Stand test will be used to assess lower extremity muscle strength and functional mobility.
Timed 25-Foot Walk - Conventional	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.
Expanded Disability Status Scale (EDSS)	Baseline	This scale will be administered by a physician to determine the level of neurological disability in individuals with multiple sclerosis.
Modified Fatigue Impact Scale (MFIS)	Baseline	This scale will be used to assess the impact of fatigue on physical, cognitive, and psychosocial functioning in individuals with multiple sclerosis.
Multiple Sclerosis Walking Scale-12 (MSWS-12)	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.
Knee Extensor Muscle Strength	Baseline	Knee extensor muscle strength will be measured using a handheld digital dynamometer to assess lower extremity muscle strength.
Handgrip Strength	Baseline	Handgrip strength will be measured using a digital dynamometer to assess upper extremity muscle strength and overall muscular function.
Participant Satisfaction	Baseline	Participant satisfaction with conventional and mixed reality-based assessments will be evaluated using a 10-point numerical rating scale.

Countries

Turkey (Türkiye)