Cut-Off Values for Gait and Balance in MS

NCT07151547 | Completed

• 1 other identifier: Gait Variability
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

cut-off; falls; gait variability; limits of stability; postural sways; multiple sclerosis

Outcome Measures

Primary Outcomes (4)

• Limits of Stability

  Limits of stability assessment will be conducted using the Bertec Balance Check Screener™ force platform system (45×45 cm, 13 cm thick), which detects body movements via foot pressure.Limits of stability will be measured by asking participants to lean maximally in four directions (forward, backward, right, left) without losing balance. Stability scores (in cm and %) will be calculated using Balance Check Software.

  up to 5 months

• Postural sways

  Postural sways assessment will be conducted using the Bertec Balance Check Screener™ force platform system (45×45 cm, 13 cm thick), which detects body movements via foot pressure. A foam pad of the same size is used to assess postural sway. Postural sways will be evaluated under four conditions (eyes open/closed on firm/foam surfaces). Participants will stand still for 10 seconds per condition, repeated three times. The average stability score (%) will be recorded for each condition.

  up to 5 months

• Gait variability

  Gait variability will be performed using the GAITRite® system, a 4.6-meter portable walkway mat embedded with pressure sensors that record step data without interfering with the natural gait. Participants will walk naturally across the mat three times; the average of the trials will be analyzed. Gait variability will be expressed as the coefficient of variation (CV) (%). Using this formula: CV (%) = (standard deviation/mean) × 100.

  up to 5 months

• Fall Histories

  The following fall-related information will be recorded: Number of Falls Cause of Fall Time of Fall Activity During Which the Fall Occurred Type of Fall Fall-Related Injury / If Present, Type of Injury

  up to 5 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MS patients with the inclusion criteria

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Muhammed Kılınç

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Ender Ayvat

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Fatma Ayvat

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: September 3, 2025
• Study Start: July 17, 2025
• Primary Completion: January 6, 2026
• Study Completion: January 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

TU (1)