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Multiple SclerosisNCT07361965

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

An observational study of Multiple Sclerosis and Mixed Reality, run by Selcuk University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Sclerosis, Mixed Reality
What is being tested?
Clinical Assessments
How many people
75 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Feb 2026to 30 Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mehmet K ALTUNOK, PHD(c) in PT contact

5558175133 ext. +90

mehmetkaan.altunok@selcuk.edu.tr

Turkey (Türkiye)1 site
  • Selcuk University Faculty of Medicine Hospital MS Life Center

    Konya, Selcuklu, 42130

    Mehmet K ALTUNOK, PHD(c) in PT, 5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr

Other trials in Turkey (Türkiye)

About this study

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

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.

Read more

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.

Being tested
Clinical Assessments
Keywords
Multiple Sclerosis, Mixed Reality, Functional Mobility, Validity, Reliability, Digital Assessment
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical AssessmentsOther

    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.

Study groups in NCT07361965
Study groupRoleWhat they receive
Individuals with Multiple SclerosisIndividuals with multiple sclerosis aged 18-60 years.
Receives: Other: Clinical Assessments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 1-week follow-up

  2. 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.

    Measured: Baseline and 1-week follow-up

  3. 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.

    Measured: Baseline and 1-week follow-up

Secondary outcomes (9)
  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: Baseline

  7. Knee Extensor Muscle Strength

    Knee extensor muscle strength will be measured using a handheld digital dynamometer to assess lower extremity muscle strength.

    Measured: Baseline

  8. Handgrip Strength

    Handgrip strength will be measured using a digital dynamometer to assess upper extremity muscle strength and overall muscular function.

    Measured: Baseline

  9. Participant Satisfaction

    Participant satisfaction with conventional and mixed reality-based assessments will be evaluated using a 10-point numerical rating scale.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start2 Feb 2026 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07361965
Sponsor's protocol ID
SelcukU_PT_MS_MR_ADAPTATION
Status last verified
Jan 2026
First submitted
15 Jan 2026
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 27456884

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis and Mixed Reality, run by Selcuk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mehmet K ALTUNOK, PHD(c) in PT (5558175133 ext. +90, mehmetkaan.altunok@selcuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed Up and Go Test - Mixed Reality (TUG-MR) (time frame: Baseline and 1-week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07361965, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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