Cut-Off Values for Gait and Balance in MS

NCT ID: NCT07151547

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-06

Study Completion Date

2026-04-06

Brief Summary

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Purpose of the Study:

The aim of this study is to determine the cut-off values of gait variability and limits of stability-postural sways scores in patients with MS in order to identify fall risk at an early stage and take necessary precautions. Additionally, the study aims to compare the effectiveness of these parameters in distinguishing between fallers and non-fallers.

The study includes four hypotheses:

H₁: Gait variability scores can differentiate between fallers and non-fallers in patients with MS.

H₂: Limits of stability and postural sways scores can differentiate between fallers and non-fallers in patients with MS.

H₃: Gait variability scores provide higher sensitivity and specificity than stability limits and postural sway scores in distinguishing between fallers and non-fallers in patients with MS.

H₄: Limits of stability and postural sways scores provide higher sensitivity and specificity than gait variability scores in distinguishing between fallers and non-fallers in patients with MS.

Detailed Description

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Gait variability will be assessed using the GaitRite gait analysis system. Limits of stability and postural sways will be evaluated using the Bertec Balance Check Screener™ force platform system. Patients' fall history (number of falls, fear of falling, location of falls, presence of injury, etc.) will also be questioned.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Multiple Sclerosis

• Patients diagnosed with MS by a neurologist according to the McDonald criteria, aged 18 years or older, having an EDSS score of ≤ 5 (able to walk independently), and having a Mini-Mental State Examination score of 24 or higher will be included in the study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with MS by a neurologist according to the McDonald criteria
* Aged 18 years or older
* EDSS ≤ 5 (able to walk independently)
* Mini-Mental State Examination score of 24 or higher

Exclusion Criteria

* Patients with neurological conditions other than MS that may affect independent walking or standing, those with lower extremity pain, or a history of lower extremity fractures within the past 6 months
* Patients who do not agree to participate or do not provide written informed consent will be excluded from the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Güngör Beyza ÖZVAR

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammed Kılınç

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Ender Ayvat

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Fatma Ayvat

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Güngör Beyza Özvar Şenöz, PhD

Role: CONTACT

+905053888617

Facility Contacts

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Güngör Beyza Özvar ŞEnöz, PhD

Role: primary

+905053888617

Other Identifiers

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Gait Variability

Identifier Type: -

Identifier Source: org_study_id

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