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临床试验/NCT06849960
NCT06849960Enrolling By Invitation不适用

Reliabilitiy and Validity of the Two-minute Step Test in Patients With Multiple Sclerosis

Sanko University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
50
试验地点
1
主要终点
2 min step test (2MST)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •being diagnosed with revised 2017 McDonald criteria,
  • •aged older than 18 years,
  • •ability to walk with or without aid,
  • •no medication changes in the last 2 months,
  • •volunteering to participate in the research,
  • •not having any obstacles to verbal and cognitive communication.

排除标准

  • •having orthopedic, psychological, and other neurological disorders, having had -a relapse in the past 3 months
  • •having pregnancy.

结局指标

主要结局

2 min step test (2MST)

时间窗: 1 years

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.

2-min walk test (2MWT)

时间窗: 1 years

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.

One-leg stand test (OLSTS)

时间窗: 1 years

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.

次要结局

未报告次要终点

研究者

发起方
Sanko University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hakan Polat

Physiotherapy and Rehabilitation Department, Assistant Professor

Sanko University

研究点 (1)

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