ClinicalTrials.gg
Not yet recruitingNCT07786987CEW-MSUpdated Aug 26, 2026

Cone Evasion Walk Test in Multiple Sclerosis

An observational study in Multiple Sclerosis, Pain Management and Function, sponsored by Hacettepe University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Hacettepe University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Multiple Sclerosis by Hacettepe University — 6 open to participants now, 6 under way, none of them phase 3. Multiple Sclerosis · Hacettepe University.

Started
2026
with 4 others
Observational
8 of 23
2 open now
Registered
22nd of 23
by date

Among the 23 studies in Multiple Sclerosis by Hacettepe University, this one is one of 5 that started in 2026, is one of 8 observational ones, and was the 22nd registered.

By phase

23 studies; the count open now beside each. This study's row is marked.

No phase15 · 4 open
Observationalthis study8 · 2 open

By the year they started

First in 2015; this study’s year is marked. 5 started in 2026.

Size and results

Median enrollment 34 across the 15 interventional studies, 56 across the 8 observational. Of the 13 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 23 studies in Multiple Sclerosis by Hacettepe University, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Multiple Sclerosis
  • Pain Management
  • Function

Browse trials for

Keywords

  • Cone Evasion Walk Test
  • multiple sclerosis
  • functional status
  • rehabilitation
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testCone Evasion Walk Test and Clinical Assessments

    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.

06

What researchers measure

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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline assessment.

07

Study locations

1 site
  • Erciyes University Faculty of Medicine Hospitals
    Erciyes, Kayseri 38039, Turkey (Türkiye)
    • Hanife ABAKAY, Assoc Prof · Contactfzthanifeabakay@gmail.com · +90 505 883 31 26
    • Ayşe GÜÇ, Assistant Professor, MD · Sub investigator
    • Mehmet Fatih YETKİN, Assoc Prof, MD · Sub investigator
    • Hanife ABAKAY, Assistant Professor, PT · Principal investigator
    • Tugba DERE, Assistant Professor, PT · Principal investigator
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2026
First posted
Aug 26, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Sep 30, 2027
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07786987
Responsible party
Tuğba DERE (Assistant Professor, Department of Physiotherapy and Rehabilitation, Bozok University) — Principal investigator
First posted
Aug 26, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Aug 26, 2026

Study contacts

Tugba DERE, Asisst Prof
Contact
tugba.dere@bozok.edu.tr
05435174952
Hanife Abakay, Assoc Prof
Contact
fzthanifeabakay@gmail.com
05435174952

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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