Cut-Off Values for Gait and Balance in MS

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT07151547
• Lead Sponsor: Hacettepe University

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-06
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Primary Completion: 2025-11-06
• Study Completion: 2026-01-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Limits of Stability	up to 5 months	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.
Postural sways	up to 5 months	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.
Gait variability	up to 5 months	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.
Fall Histories	up to 5 months	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

Trial Locations

Locations (1)

Hacettepe University; Ankara, Altındağ, Turkey (Türkiye)