An observational study in Multiple Sclerosis, sponsored by Sanko University. Enrolling by invitation at 2 sites in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-27.
Sponsored by Sanko University · Observational
The study will include 50 MS patients who were examined by a specialist neurologist diagnosed according to McDonalds criteria in the Neurology Outpatient Clinic of SANKO University Sani Konukoğlu Application and Research Hospital and whose informed consent was obtained. Ethical approval of the study was obtained from SANKO University Non-Interventional Clinical Research Ethics Committee (No:2025/01- ethics committee decision No:2).
MS patients between the ages of 18-65 years, with an Expanded Disability Status Scale (EDSS) score ≤ 4, who are not pregnant, who have not had an attack in the last 1 month and who have not received corticosteroid treatment will be included in the study. Individuals who have taken any medication that may affect walking and balance ability in the last month, have orthopedic, other neurologic diseases and cognitive problems will not be included in the study.
Demographic information (age, height, weight, body mass index and gender) of individuals with MS will be recorded. Firstly, the tests will be explained to the individuals in detail.Assessments will be performed by a physiotherapist with 10 years of experience in this field.
Multiple Sclerosis (MS) is a demyelinating, inflammatory, neurodegenerative and progressive disease with a complex etiology. the symptoms of the disease vary according to the lesion site and generally include problems such as balance and fall problems, fatigue, loss of strength and spasticity in the lower extremities, and sensory disturbances.
The study will include 50 MS patients who were examined by a specialist neurologist diagnosed according to McDonalds criteria in the Neurology Outpatient Clinic of SANKO University Sani Konukoğlu Application and Research Hospital and whose informed consent was obtained. Ethical approval of the study was obtained from SANKO University Non-Interventional Clinical Research Ethics Committee (No:2025/01- ethics committee decision No:2).
MS patients between the ages of 18-65 years, with an Expanded Disability Status Scale (EDSS) score ≤ 4, who are not pregnant, who have not had an attack in the last 1 month and who have not received corticosteroid treatment will be included in the study. Individuals who have taken any medication that may affect walking and balance ability in the last month, have orthopedic, other neurologic diseases and cognitive problems will not be included in the study.
Demographic information (age, height, weight, body mass index and gender) of individuals with MS will be recorded. Firstly, the tests will be explained to the individuals in detail.Assessments will be performed by a physiotherapist with 10 years of experience in this field.
Assessments will be performed separately by two physiotherapists on two consecutive days. Each physiotherapist will administer the tests in two separate sessions on one day. The time to complete the activities during the tests will be recorded with a stopwatch. Patients will be unaware of the recorded time. Individuals will be rested before the tests. On the first day, the first assessor will administer the 2MST in the first session. Then 2MWT and Single Leg Stance tests will be performed respectively. In the next session, the second evaluator will perform the 2MST. On the 2nd day of the assessment, the second assessor will first perform the 2MST. Then, the first assessor will perform the 2MST. In both sessions, individuals will be assessed in the same environment to minimize the influence of environmental factors. This environment has adequate lighting and the floor of the room has a hard surface as a safety precaution due to the risk of falling. Due to the risk of heat intolerance problem in MS, attention was paid to the room temperature and the room temperature will be at normal room temperature.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 970 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Sanko University is the lead sponsor of 52 studies on the registry; 11 are open to participants now.
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PATIENTS DIAGNOSED WITH MULTIPLE SCLEROSIS ADMITTED TO THE NEUROLOGY OUTPATIENT CLINIC OF SANKO UNİVERSİTESİ SANİ KONUKOĞLU APPLICATION AND RESEARCH HOSPITA
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
2 min step test (2MST)
The 2MST is a test used to measure physical performance. Before starting the test, the wall was marked with tape at the midpoint between the spina iliaca anteriosuperior and the patella. The participant was asked to start walking in place without running when the signal was given. During the test, the number of right and left knee lifts reaching the mark within 2 minutes was recorded . The most affected side's results of patients were used for analysis.
Time frame: 1 years
2-min walk test (2MWT)
This test measures the distance that individuals walk in 2 minutes and assesses their functional capacity. The person walks for 2 minutes at maximum speed between two cones placed by measuring 15 meters. If an assistive device is used, the person can walk with the device. Since 6-minute walk test may cause fatigue in MS patients, 2MWT is recommended. Its validity in MS was demonstrated by Scalzitti et al.
Time frame: 1 years
One-leg stand test (OLSTS)
OLSTS measured the time that the person could maintain the posture without losing balance in a standing position on one leg with eyes open. It was repeated for both feet. The most affected side's results of patients were used for analysis.
Time frame: 1 years
Plan to share: Undecided — will be decided when the study is completed
Ran from Feb 2025 to primary completion in Feb 2025, 0 months.
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