NCT07786987

Brief 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). 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
12mo left

Started Oct 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Sep 2027

First Submitted

Initial submission to the registry

August 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 22, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

Cone Evasion Walk Testmultiple sclerosisfunctional statusrehabilitation

Outcome Measures

Primary Outcomes (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.

    Baseline and 3-7 days after baseline assessment

Secondary Outcomes (7)

  • Expanded Disability Status Scale (EDSS)

    Baseline assessment.

  • Timed 25-Foot Walk Test (T25FW)

    Baseline assessment.

  • Dynamic Gait Index (DGI)

    Baseline assessment.

  • Symbol Digit Modalities Test (SDMT)

    Baseline assessment.

  • Falls Efficacy Scale-International (FES-I)

    Baseline assessment.

  • +2 more secondary outcomes

Study Arms (1)

Individuals with Multiple Sclerosis

Individuals 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.

Diagnostic Test: Cone Evasion Walk Test and Clinical Assessments

Interventions

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.

Individuals with Multiple Sclerosis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Faculty of Medicine Hospitals

Erciyes, Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Multiple SclerosisAgnosia

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Tugba DERE, Asisst Prof

CONTACT

Hanife Abakay, Assoc Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Physiotherapy and Rehabilitation

Study Record Dates

First Submitted

August 22, 2026

First Posted

August 26, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations