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临床试验/NCT03508284
NCT03508284已完成不适用

Factors Associated With Dual-Task Performance in Patients With Multiple Sclerosis

Gazi University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月18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
60
试验地点
1
主要终点
Modified Sensory Organization Test

研究概览

简要总结

Multiple sclerosis (MS) is a chronic inflammatory disease affecting the central nervous system. It is reported that 85% of patients with multiple sclerosis have gait disturbance, 88% balance, and 35-90% fatigue (1, 2, 3). In addition, 65% of patients are reported that their cognitive functions have regressed (4).

It is important to increase the independence of the MS patients in activities of daily living (ADL). Almost all of ADL requires many activities at the same time. For example, toothbrushing involves both the standing balance and the motor activity of the upper limb at the same time. It also requires cognitive tasks such as attention and focusing. Many activities that seem to be the only task are actually multitasking (5).

The aim of this study is to investigate the effects of motor and cognitive additional task on balance, mobility and upper limb performances in MS patients and to determine the factors associated with dual-task performance.

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 balance, mobility, upper extremity performance, cognitive function, fatigue, physical activity level, mood, sleep quality, quality of life will be evaluated once.

We will use descriptive statistics and t-tests to compare demographic characteristics between groups and for the categorical variables chi-square. Effect of the group (MS patients or healthy controls), condition (Single task and dual-task conditions), and group × condition interaction will be compared using two-way repeated measures ANOVA. We will examine the correlations between fatigue severity, physical activity level, mood, sleep quality, quality of life 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
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

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

Modified Sensory Organization Test

时间窗: Fifteen minutes

The Modified Sensory Organization Test, which is performed using computerized posturography, measures postural sway in response to 4 different sensory conditions is measured using a force platform. * Cognitive additional task (arithmetic) * Cognitive additional task (verbal)

Timed Up and Go Test

时间窗: ten minutes

Timed up and go test measures the time taken in seconds to arise from a standard chair, walk 3 m, turn through 180 degrees, walk back, and sit down again. Cognitive additional task (arithmetic): Individuals will be asked to perform tasks by counting backward from 3 to 3 from 100. Cognitive additional task (verbal): Individuals will be asked to fulfill their duties by producing a vegetable-fruit name.

upper extremity function

时间窗: ten minutes

9-Hole Peg Test * Cognitive additional task (arithmetic) * Cognitive additional task (verbal)

次要结局

  • Sleep Quality: PSQI(5-10 minutes)
  • Fatigue Severity(Five minutes)
  • selective attention(Five minutes)
  • Mood(one minute)
  • Balance Confidence(five minutes)
  • Visual attention and task switching(Five minutes)
  • cognitive function(thirty minutes)

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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