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Multiple SclerosisCEW-MSNCT07786987

Cone Evasion Walk Test in Multiple Sclerosis

An observational study of Multiple Sclerosis and Pain Management, run by Hacettepe 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

This cross-sectional methodological study aims to examine the test-retest reliability, intrasession reliability, and construct validity of the Cone Evasion Walk (CEW) Test in individuals diagnosed with Multiple Sclerosis (MS). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Multiple Sclerosis, Pain Management, Function
What is being tested?
Cone Evasion Walk Test and Clinical Assessments
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2026to 30 Sep 2027
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will consist of adults with a confirmed diagnosis of multiple sclerosis who meet the predefined eligibility criteria. Participants will be recruited from individuals with multiple sclerosis and will undergo the Cone Evasion Walk Test and standardized clinical assessments to investigate the reliability and validity of the test in this population.

Who may be able to join

  • Confirmed diagnosis of Multiple Sclerosis according to the 2017 revised McDonald criteria Age between 18 and 65 years Expanded Disability Status Scale (EDSS) score ≤6.0 Clinically stable, with no MS relapse within the previous 30 days Able to walk at least 10 meters independently, with or without a unilateral assistive device Able to understand and follow study instructions Willing and able to provide written informed consent

Who cannot join

  • MS relapse within the previous 30 days Cognitive impairment that prevents understanding of instructions or completion of the study assessments Co-existing orthopedic, cardiovascular, vestibular, or neurological conditions other than MS that significantly affect gait, balance, or safe performance of the CEW Severe uncorrected visual impairment that may interfere with obstacle detection Wheelchair-dependent mobility or requirement for bilateral walking aids Change in MS-related medication within the previous 30 days Participation in a structured exercise or rehabilitation program within the previous 4 weeks

Trial locations and contacts

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

Tugba DERE, Asisst Prof contact

05435174952

tugba.dere@bozok.edu.tr

Hanife Abakay, Assoc Prof contact

05435174952

fzthanifeabakay@gmail.com

Turkey (Türkiye)1 site
  • Erciyes University Faculty of Medicine Hospitals

    Erciyes, Kayseri, 38039

    Hanife ABAKAY, Assoc Prof, +90 505 883 31 26, fzthanifeabakay@gmail.com

    Ayşe GÜÇ, Assistant Professor, MD

Other trials in Turkey (Türkiye)

About this study

Official title: Reliability and Validity of the Cone Evasion Walk Test in Individuals With Multiple Sclerosis

This cross-sectional methodological study aims to examine the test-retest reliability, intrasession reliability, and construct validity of the Cone Evasion Walk (CEW) Test in individuals diagnosed with Multiple Sclerosis (MS). The CEW test is a performance-based clinical assessment that evaluates dynamic balance, obstacle avoidance, and fall risk by quantifying the number of cones contacted during a standardized walking task. Although the psychometric properties of the CEW test have been established in populations including stroke survivors, patients with knee osteoarthritis, and patients with hip osteoarthritis, no study has yet investigated its measurement properties in individuals with MS. Given the multifaceted nature of gait and balance impairments in MS - encompassing motor, sensory, cognitive, and visuospatial deficits - the CEW test may serve as a clinically meaningful and ecologically valid tool in this population. Participants will be recruited from the Department of Neurology at Erciyes University Hospital and will undergo the CEW test along with a comprehensive battery of established mobility and balance outcome measures.

Read the detailed description

Multiple Sclerosis (MS) is a chronic, immune-mediated, inflammatory, and neurodegenerative disease of the central nervous system characterized by demyelination and axonal loss. Individuals with MS frequently experience impairments in balance, gait, and functional mobility, which collectively contribute to an elevated risk of falls. Approximately 50-60% of individuals with MS report at least one fall within a 6-month period, underscoring the critical need for clinically feasible and psychometrically sound assessment tools to identify those at risk.

The Cone Evasion Walk (CEW) Test is a relatively novel, performance-based assessment tool originally developed to evaluate dynamic balance and obstacle avoidance during walking. The test involves walking along a 3-meter pathway lined with 10 cones (5 on each side), during which the individual must avoid contacting the cones. The primary outcome is the total number of cones touched, reflecting the individual s capacity to integrate cognitive, perceptual, and neuromusculoskeletal functions during ambulation. Prior psychometric evaluations have demonstrated excellent reliability in acute stroke (ICC: 0.88-0.98; Sjoeholm et al., 2019), knee osteoarthritis (ICC: 0.97), and hip osteoarthritis (ICC: 0.96) populations, as well as significant concurrent validity with established measures including the Timed Up and Go (TUG), Functional Ambulation Classification (FAC), and 6-Minute Walk Test (6MWT).

However, the psychometric properties of the CEW test have not been investigated in individuals with MS, despite the strong clinical rationale for its application in this population. MS-related deficits in attention, visuospatial processing, proprioception, and motor control - all of which are inherently assessed by the CEW test - make it a theoretically appropriate and ecologically valid measure for this patient group.

This study will employ a cross-sectional, methodological design. Eligible participants diagnosed with MS according to the revised McDonald criteria, with an Expanded Disability Status Scale (EDSS) score of 6.5 or less, will be recruited from the Department of Neurology at Erciyes University Hospital, Kayseri, Turkey.

Participants will undergo the following assessments at baseline: the CEW test (administered twice within the same session to evaluate intrasession reliability), the Timed Up and Go (TUG) test, the Timed 25-Foot Walk (T25FW) test, the 6-Minute Walk Test (6MWT), the Berg Balance Scale (BBS), the Dynamic Gait Index (DGI), the Falls Efficacy Scale-International (FES-I), and the 12-Item Multiple Sclerosis Walking Scale (MSWS-12). To assess test-retest reliability, participants will repeat the CEW test 3-7 days after the initial assessment.

Statistical analyses will include intraclass correlation coefficients (ICC, two-way mixed model, absolute agreement) for reliability assessment, Spearman rank correlation coefficients for construct validity, and Bland-Altman analysis for agreement between repeated measurements. Minimal detectable change (MDC) and standard error of measurement (SEM) will also be calculated.

This study is expected to contribute to the existing body of evidence by establishing the reliability and validity of the CEW test in MS and providing clinicians with a practical, time-efficient tool for assessing dynamic balance and fall risk in clinical practice.

Being tested
Cone Evasion Walk Test and Clinical Assessments
Keywords
Cone Evasion Walk Test, multiple sclerosis, functional status, rehabilitation
Medical subject headings
Multiple Sclerosis, Agnosia

What participants receive

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

  • Cone Evasion Walk Test and Clinical AssessmentsDiagnostic test

    The Cone Evasion Walk Test is a performance-based walking assessment designed to evaluate the ability to negotiate and evade obstacles during walking. The test will be administered to individuals with multiple sclerosis to investigate its reliability and validity.

Study groups in NCT07786987
Study groupRoleWhat they receive
Individuals with Multiple SclerosisIndividuals with multiple sclerosis who meet the predefined eligibility criteria and undergo the Cone Evasion Walk Test and other clinical assessments as part of the study protocol. No therapeutic intervention will be administered.
Receives: Diagnostic Test: Cone Evasion Walk Test and Clinical Assessments

What is being measured

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

  1. Test-retest Reliability of the Cone Evasion Walk Test

    Test-retest reliability of the Cone Evasion Walk (CEW) Test assessed using the intraclass correlation coefficient (ICC, two-way mixed model, absolute agreement) between two test sessions administered 3 to 7 days apart. The total number of cones touched during the walk test will be recorded as the primary score.

    Measured: Baseline and 3-7 days after baseline assessment

Secondary outcomes (7)
  1. Expanded Disability Status Scale (EDSS)

    The Expanded Disability Status Scale (EDSS) will be used to assess the overall level of neurological disability in individuals with multiple sclerosis. The EDSS provides a standardized measure of disability ranging from 0 to 10, with higher scores indicating greater disability. The EDSS will be used to examine the relationship between overall MS-related disability and performance on the Cone Evasion Walk Test.

    Measured: Baseline assessment.

  2. Timed 25-Foot Walk Test (T25FW)

    The Timed 25-Foot Walk Test (T25FW) will be used to assess walking speed and ambulatory function in individuals with multiple sclerosis. Participants will be instructed to walk a 25-foot (7.62-meter) distance as quickly and safely as possible. The time required to complete the walk will be recorded in seconds. Lower completion times indicate better walking performance. The T25FW will be used to examine the relationship between established ambulatory performance and Cone Evasion Walk Test performance.

    Measured: Baseline assessment.

  3. Dynamic Gait Index (DGI)

    The Dynamic Gait Index (DGI) will be used to assess dynamic gait performance and the ability to adapt walking to changing task and environmental demands in individuals with multiple sclerosis. The DGI consists of eight walking tasks, including changes in gait speed, horizontal and vertical head movements, pivot turning, stepping over and around obstacles, and stair negotiation. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 24, with higher scores indicating better dynamic gait performance.

    Measured: Baseline assessment.

  4. Symbol Digit Modalities Test (SDMT)

    The Symbol Digit Modalities Test (SDMT) will be used to assess information processing speed and cognitive efficiency in individuals with multiple sclerosis. Participants will be asked to match geometric symbols with corresponding numbers according to a provided key within a specified time period. Higher scores indicate better information processing speed. The SDMT will be used to examine the relationship between cognitive processing speed and Cone Evasion Walk Test performance.

    Measured: Baseline assessment.

  5. Falls Efficacy Scale-International (FES-I)

    The Falls Efficacy Scale-International (FES-I) will be used to assess concerns about falling during daily activities in individuals with multiple sclerosis. The scale evaluates the level of concern about falling while performing a range of everyday activities. Higher scores indicate greater concern about falling. The FES-I will be used to examine the relationship between concerns about falling and Cone Evasion Walk Test performance.

    Measured: Baseline assessment.

  6. Multiple Sclerosis Impact Scale-29 (MSIS-29)

    The Multiple Sclerosis Impact Scale-29 (MSIS-29) will be used to assess the physical and psychological impact of multiple sclerosis on individuals' daily lives. The scale consists of 29 items, with higher scores indicating a greater perceived impact of MS. The MSIS-29 will be used to examine the relationship between the impact of MS on daily life and Cone Evasion Walk Test performance.

    Measured: Baseline assessment.

  7. Timed Up and Go Test (TUG)

    The Timed Up and Go Test (TUG) will be used to assess functional mobility and dynamic balance in individuals with multiple sclerosis. Participants will be instructed to stand up from a standard chair, walk 3 meters at a comfortable and safe pace, turn around, walk back to the chair, and sit down. The time required to complete the test will be recorded in seconds. Lower completion times indicate better functional mobility.

    The TUG will be used to examine the relationship between functional mobility and Cone Evasion Walk Test performance.

    Measured: Baseline assessment.

Timeline

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

  1. First posted26 Aug 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Sep 2027 (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
Cohort
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07786987
Sponsor's protocol ID
CEW-MS-2026-001
Acronym
CEW-MS
Status last verified
Aug 2026
First submitted
22 Aug 2026
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared with other researchers because no data-sharing plan has been established for this study. Data will be handled confidentially and in accordance with applicable ethical and data protection requirements.

Publications

  • Estella A, Gamazo-Del Rio J, Alvarez-Manzanares J, Julian-Jimenez A, Gonzalez Del Castillo J. Prognostic accuracy of qsofa according to the site of infection in older patient attended in Emergency Department. Eur J Intern Med. 2018 Apr;50:e13-e15. doi: 10.1016/j.ejim.2018.01.005. Epub 2018 Jan 4. No abstract available.

    PubMed 29307503
  • Ozden F, Ozkeskin M, Yuceyar N. The reliability and validity of the Turkish version of the multiple sclerosis impact scale-29. Turk J Med Sci. 2022 Aug;52(4):1216-1222. doi: 10.55730/1300-0144.5426. Epub 2022 Aug 10.

    PubMed 36326386
  • Metzler P, Zemann W, Jacobsen C, Gratz KW, Obwegeser JA. Cranial vault growth patterns of plagiocephaly and trigonocephaly patients following fronto-orbital advancement: a long-term anthropometric outcome assessment. J Craniomaxillofac Surg. 2013 Sep;41(6):e98-e103. doi: 10.1016/j.jcms.2012.11.035. Epub 2013 Jan 17.

    PubMed 23332468
  • Strober L, DeLuca J, Benedict RH, Jacobs A, Cohen JA, Chiaravalloti N, Hudson LD, Rudick RA, LaRocca NG; Multiple Sclerosis Outcome Assessments Consortium (MSOAC). Symbol Digit Modalities Test: A valid clinical trial endpoint for measuring cognition in multiple sclerosis. Mult Scler. 2019 Nov;25(13):1781-1790. doi: 10.1177/1352458518808204. Epub 2018 Oct 18.

    PubMed 30334474
  • Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.

    PubMed 6685237
  • Bennett SE, Bromley LE, Fisher NM, Tomita MR, Niewczyk P. Validity and Reliability of Four Clinical Gait Measures in Patients with Multiple Sclerosis. Int J MS Care. 2017 Sep-Oct;19(5):247-252. doi: 10.7224/1537-2073.2015-006.

    PubMed 29070965
  • Thompson DP, Moula K, Woby SR. Are fear of movement, self-efficacy beliefs and fear of falling associated with levels of disability in people with osteoarthritis of the knee? A cross sectional study. Musculoskeletal Care. 2017 Sep;15(3):257-262. doi: 10.1002/msc.1167. Epub 2016 Dec 7.

    PubMed 27925419

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis and Pain Management, run by Hacettepe 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 1 inclusion and 1 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 26 Aug 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 Tugba DERE, Asisst Prof (05435174952, tugba.dere@bozok.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test-retest Reliability of the Cone Evasion Walk Test (time frame: Baseline and 3-7 days after baseline assessment). 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 NCT07786987, which also lists 7 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 26 Aug 2026.

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