NCT07361965

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
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Selcuk University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Mixed Reality

Interventions

Type	Name	Description
OTHER	Clinical 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.

Timeline

• Start date: 2026-02-02
• Primary completion: 2026-06-30
• Completion: 2026-07-30
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

1 site across 1 country: Turkey (Türkiye)