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Completed

NCT Number: NCT07151547

Cut-Off Values for Gait and Balance in MS

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Limits of Stability

    Time frame: 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.

  2. Postural sways

    Time frame: 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.

  3. Gait variability

    Time frame: 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.

  4. Fall Histories

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Determination of Cut-Off Values for Gait Variability and Balance Scores in Patients With Multiple Sclerosis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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