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Cut-Off Values for Gait and Balance in MS

H

Hacettepe University

Status

Enrolling

Conditions

Multiple Sclerosis

Study type

Observational

Funder types

Other

Identifiers

NCT07151547
Gait Variability

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

60 participants in 1 patient group

Multiple Sclerosis
Description:
• 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.

Trial contacts and locations

1

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Central trial contact

Güngör Beyza Özvar Şenöz, PhD

Data sourced from clinicaltrials.gov

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