Cut-off values for gait and balance to spot fall risk in people with MS.
Determination of Cut-Off Values for Gait Variability and Balance Scores in Patients With Multiple Sclerosis
Hacettepe University · NCT07151547
We will see if gait variability and balance (limits of stability and postural sway) measurements can identify people with MS who are more likely to fall.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hacettepe University (other) |
| Locations | 1 site (Ankara, Altındağ) |
| Trial ID | NCT07151547 on ClinicalTrials.gov |
What this trial studies
This observational study will compare people with MS who have a history of falls to those who do not to determine threshold (cut-off) values for gait variability and balance metrics. Gait variability will be measured with the GaitRite gait analysis system, while limits of stability and postural sway will be measured with the Bertec Balance Check Screener force platform. Participants will also be asked about fall history, fear of falling, fall locations, and injuries to classify fallers versus non-fallers. The study will derive cut-offs and report sensitivity and specificity of each parameter for identifying fall risk.
Who should consider this trial
Good fit: Adults (18+) with neurologist-confirmed MS, an EDSS score of 5 or less, and a Mini-Mental State Examination score of 24 or higher who can walk independently are ideal candidates.
Not a fit: People with EDSS scores above 5, other neurological or recent lower-extremity conditions that affect walking or standing, or recent lower-extremity fractures are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the results could allow earlier identification of people with MS at higher risk of falls so clinicians can target fall-prevention measures.
How similar studies have performed: Previous research has linked gait variability and postural sway to fall risk in MS and older adults, but validated cut-off values are limited, so this work is partly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ankara, Altındağ
- Hacettepe University — Ankara, Altındağ, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Muhammed Kılınç — Hacettepe University
- Study coordinator: Güngör Beyza Özvar Şenöz, PhD
- Email: beyzaozvar@gmail.com
- Phone: +905053888617
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, cut-off, falls, gait variability, limits of stability, postural sways, multiple sclerosis