Multiple SclerosisNCT07151547
Cut-Off Values for Gait and Balance in MS
An observational study of Multiple Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2025to 31 Jan 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MS patients with the inclusion criteria
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Cut-Off Values for Gait Variability and Balance Scores in Patients With Multiple Sclerosis
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.
Read more
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Keywords
- cut-off, falls, gait variability, limits of stability, postural sways, multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start17 Jul 2025
- Primary completion6 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güngör Beyza ÖZVAR, Hacettepe University
- Investigators
- Muhammed Kılınç, Principal investigator, Hacettepe UniversityEnder Ayvat, Principal investigator, Hacettepe UniversityFatma Ayvat, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151547
- Sponsor's protocol ID
- Gait Variability
- Status last verified
- May 2026
- First submitted
- 6 Aug 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Cut-Off Values for Gait Variability and Balance Scores in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07151547
- Acronym / sponsor ID
- Gait Variability
- Conditions
- Multiple Sclerosis
- Keywords
- cut-off, falls, gait variability, limits of stability, postural sways, multiple sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MS patients with the inclusion criteria
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammed Kılınç principal investigator
Hacettepe University
Ender Ayvat principal investigator
Hacettepe University
Fatma Ayvat study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limits of Stability (time frame: up to 5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 4 Nov 2026.