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

NCT07361965 | Not Yet Recruiting

• 1 other identifier: SelcukU_PT_MS_MR_ADAPTATION
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Mixed Reality; Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (3)

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

  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.

  Baseline and 1-week follow-up

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

  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.

  Baseline and 1-week follow-up

• Timed 25-Foot Walk - Mixed Reality (T25FW-MR)

  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.

  Baseline and 1-week follow-up

Secondary Outcomes (9)

• Timed Up and Go Test - Conventional

  Baseline

• Five-Repetition Sit-to-Stand Test - Conventional

  Baseline

• Timed 25-Foot Walk - Conventional

  Baseline

• Expanded Disability Status Scale (EDSS)

  Baseline

• Modified Fatigue Impact Scale (MFIS)

  Baseline

Study Arms (1)

Individuals with Multiple Sclerosis

Individuals with multiple sclerosis aged 18-60 years.

Other: Clinical Assessments

Interventions

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.

Individuals with Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with MS who applied to the Selçuk University Faculty of Medicine Hospital MS Living Center

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University Faculty of Medicine Hospital MS Life Center

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• İsmail ÖZSOY, Assoc. Prof. Dr.

  Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  STUDY CHAIR

• Zehra KORKUT, Assist. Prof. Dr.

  Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  STUDY CHAIR

• Gülşah ÖZSOY, Assist. Prof. Dr.

  Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  STUDY CHAIR

• Mehmet A GÜLER, PhD

  Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  STUDY CHAIR

• Yasemin GEDİKLİ ERTÜRK, MSc. in PT

  Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

  STUDY CHAIR

• İhsan KODAK, Assist. Prof. Dr.

  Kırşehir Ahi Evran University, School of Physical Therapy and Rehabilitation, Kırşehir, Türkiye

  STUDY CHAIR

• Haluk GÜMÜŞ, Prof. Dr.

  Selçuk University, Faculty of Medicine, Department of Neurology, Konya, Türkiye

  STUDY CHAIR

• Süeda E YILMAZ, Dr.

  Rize State Hospital, Department of Neurology, Rize, Türkiye

  STUDY CHAIR

• Leyla ÖZTÜRK SÖNMEZ, Dr.

  Selçuk University, Faculty of Medicine, Department of Neurology, Konya, Türkiye

  STUDY CHAIR

• Tuğbanur BAYTOK, Dr.

  Selçuk University, Faculty of Medicine, Department of Neurology, Konya, Türkiye

  STUDY CHAIR

Central Study Contacts

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

5558175133; mehmetkaan.altunok@selcuk.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)