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

Official 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

Overview

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

• 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.

Primary outcome measures

• Timed Up and Go Test - Mixed Reality (TUG-MR) [Time frame: Baseline and 1-week follow-up]
• Five-Repetition Sit-to-Stand Test - Mixed Reality (5xSTS-MR) [Time frame: Baseline and 1-week follow-up]
• Timed 25-Foot Walk - Mixed Reality (T25FW-MR) [Time frame: Baseline and 1-week follow-up]

Secondary outcome measures (9)

• Timed Up and Go Test - Conventional [Time frame: Baseline]
• Five-Repetition Sit-to-Stand Test - Conventional [Time frame: Baseline]
• Timed 25-Foot Walk - Conventional [Time frame: Baseline]
• Expanded Disability Status Scale (EDSS) [Time frame: Baseline]
• Modified Fatigue Impact Scale (MFIS) [Time frame: Baseline]
• Multiple Sclerosis Walking Scale-12 (MSWS-12) [Time frame: Baseline]
• Knee Extensor Muscle Strength [Time frame: Baseline]
• Handgrip Strength [Time frame: Baseline]
• Participant Satisfaction [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Turkey (Türkiye) · 1 center

• Selcuk University Faculty of Medicine Hospital MS Life Center — Konya

Publications

• Ramari C, Hvid LG, David AC, Dalgas U. The importance of lower-extremity muscle strength for lower-limb functional capacity in multiple sclerosis: Systematic review. Ann Phys Rehabil Med. 2020 Mar;63(2):123-137. doi: 10.1016/j.rehab.2019.11.005. Epub 2019 Dec 6. PMID 31816449
• Casuso-Holgado MJ, Martin-Valero R, Carazo AF, Medrano-Sanchez EM, Cortes-Vega MD, Montero-Bancalero FJ. Effectiveness of virtual reality training for balance and gait rehabilitation in people with multiple sclerosis: a systematic review and meta-analysis. Clin Rehabil. 2018 Sep;32(9):1220-1234. doi: 10.1177/0269215518768084. Epub 2018 Apr 13. PMID 29651873
• Maggio MG, Russo M, Cuzzola MF, Destro M, La Rosa G, Molonia F, Bramanti P, Lombardo G, De Luca R, Calabro RS. Virtual reality in multiple sclerosis rehabilitation: A review on cognitive and motor outcomes. J Clin Neurosci. 2019 Jul;65:106-111. doi: 10.1016/j.jocn.2019.03.017. Epub 2019 Mar 18. PMID 30898488
• Massetti T, Trevizan IL, Arab C, Favero FM, Ribeiro-Papa DC, de Mello Monteiro CB. Virtual reality in multiple sclerosis - A systematic review. Mult Scler Relat Disord. 2016 Jul;8:107-12. doi: 10.1016/j.msard.2016.05.014. Epub 2016 May 21. PMID 27456884

Identifiers

NCT: NCT07361965 · SelcukU_PT_MS_MR_ADAPTATION

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗