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NCT07361965Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
75 (estimated)
First submitted
15 Jan 2026
Start date
2 Feb 2026
Primary completion date
30 Jun 2026
Lead sponsor
Selcuk University
NCT number
NCT07361965

What you commit to

  • Study type: Observational
  • Planned participants: 75
  • From 2 Feb 2026 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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,
  • 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),

Other

  • Having experienced a multiple sclerosis relapse or undergone a change in MS-related treatment within the past 6 months,
  • 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,
  • Experiencing dizziness, nausea, or virtual reality-related symptoms (VR sickness) during testing,
  • Insufficient motivation or poor compliance that may hinder participation in the study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Selcuk University Faculty of Medicine Hospital MS Life Center
Coordinator of this site? Confirm its status
KonyaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.