Reliability and Validity of the Cone Evasion Walk Test in Individuals With Multiple Sclerosis
| Registry | NCT07786987, acronym CEW-MS |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 50 (Estimated) |
| Sponsor | Hacettepe University (Other) |
| Conditions | Multiple Sclerosis, Pain Management, Function |
| Interventions | Cone Evasion Walk Test and Clinical Assessments (Diagnostic test) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-06-30 (estimated), completion 2027-09-30 (estimated), first posted 2026-08-26, last updated 2026-08-26 |
| Locations | 1 site in Turkey (Türkiye) |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Individuals with Multiple Sclerosis | Diagnostic Test: Cone Evasion Walk Test and Clinical Assessments | 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. |
Sex: All, ages: 18 Years to 70 Years
Inclusion Criteria: 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 Exclusion Criteria: 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
| Facility | City | Country | Status |
|---|---|---|---|
| Erciyes University Faculty of Medicine Hospitals | Erciyes, Kayseri | Turkey (Türkiye) |