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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis; Mixed Reality
• Intervention / Treatment: Other: Clinical Assessments

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Mehmet K ALTUNOK, PHD(c) in PT; Phone Number: +90 5558175133; Email: mehmetkaan.altunok@selcuk.edu.tr

Study Locations

• Turkey (Türkiye)
  • Selcuklu
    • Konya, Selcuklu, Turkey (Türkiye), 42130
      • Selcuk University Faculty of Medicine Hospital MS Life Center
      • Contact: Mehmet K ALTUNOK, PHD(c) in PT; Phone Number: +90 5558175133; Email: mehmetkaan.altunok@selcuk.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Individuals with Multiple Sclerosis; Individuals with multiple sclerosis aged 18-60 years.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Study Chair: Haluk GÜMÜŞ, Prof. Dr., Selçuk University, Faculty of Medicine, Department of Neurology, Konya, Türkiye; Study Chair: Gülşah ÖZSOY, Assist. 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: İsmail ÖZSOY, Assoc. 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: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Validity; Reliability; Functional Mobility; Mixed Reality; Digital Assessment
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: SelcukU_PT_MS_MR_ADAPTATION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No