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临床试验/NCT03594357
NCT03594357已完成不适用

The Relationship of Cognitive Functions to Physical and Personal Factors in Patients With Multiple Sclerosis

Gazi University1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2018年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
137
试验地点
1
主要终点
cognitive function

研究概览

简要总结

Approximately 65% of multiple sclerosis (MS) patients appear to have problems in their cognitive function. Long-term memory is one of the most frequently affected functions in MS patients. Many factors play a role in the deterioration of cognitive functions because of many symptoms of MS.

The aim of this study is to investigate the relationship of cognitive function with physical factors such as balance, functional exercise capacity and personal factors such as fatigue level, mood, sleep quality in patients with MS.

详细描述

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The cognitive function, balance, functional exercise capacity, fatigue, mood, sleep quality will be evaluated once.

Investigators will use descriptive statistics and t-tests to compare variables between groups. Investigators will examine the correlations between variables using Pearson bivariate correlations. The significance level is set at p<0,05.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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
是

入选标准

  • •Participants who 18-65 years of age
  • •MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.

排除标准

  • •Participants who have orthopedic, vision, hearing, or perception problems

结局指标

主要结局

cognitive function

时间窗: baseline

The Brief Repeatable Battery of Neuropsychological Tests will be used. The Brief Repeatable Battery of Neuropsychological Tests (BRB-N) consists of the selective reminding, 10/36 spatial recall, symbol digit modalities, paced auditory serial addition (PASAT) and word list generation tests.

次要结局

  • Balance(baseline)
  • Mood(baseline)
  • Fatigue(baseline)
  • Functional exercise capacity.(baseline)
  • Sleep Quality(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cagla Ozkul

research assistant

Gazi University

研究点 (1)

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