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NCT Number: NCT07786987

Cone Evasion Walk Test in 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erciyes University Faculty of Medicine Hospitals

Erciyes, Kayseri, 38039, Turkey (Türkiye)

Location contact

Ayşe GÜÇ, Assistant Professor, MD

SUB_INVESTIGATOR

Hanife ABAKAY, Assistant Professor, PT

PRINCIPAL_INVESTIGATOR

Hanife ABAKAY, Assoc Prof

CONTACT

[email protected]

+90 505 883 31 26

Mehmet Fatih YETKİN, Assoc Prof, MD

SUB_INVESTIGATOR

Tugba DERE, Assistant Professor, PT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cone Evasion Walk Test and Clinical Assessments

Diagnostic 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.

Primary outcomes

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

    Time frame: Baseline and 3-7 days after baseline assessment

    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.

Secondary outcomes

  1. Expanded Disability Status Scale (EDSS)

    Time frame: Baseline assessment.

    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.

  2. Timed 25-Foot Walk Test (T25FW)

    Time frame: Baseline assessment.

    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.

  3. Dynamic Gait Index (DGI)

    Time frame: Baseline assessment.

    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.

  4. Symbol Digit Modalities Test (SDMT)

    Time frame: Baseline assessment.

    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.

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

    Time frame: Baseline assessment.

    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.

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

    Time frame: Baseline assessment.

    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.

  7. Timed Up and Go Test (TUG)

    Time frame: Baseline assessment.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanife Abakay, Assoc Prof

CONTACT

[email protected]

05435174952

Tugba DERE, Asisst Prof

CONTACT

[email protected]

05435174952

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Acronym: CEW-MS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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