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临床试验/NCT03505294
NCT03505294已完成不适用

The Effect of Task-Oriented Training on the Physical and Cognitive Functions in Patients With Multiple Sclerosis

Gazi University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年6月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
cognitive function

研究概览

简要总结

It is reported that 85% of MS patients have gait disturbance, 87.9% balance, 35-90% fatigue and 45-60% cognitive problems. Rehabilitation approaches based on the motor control systems model, the plasticity concept, the motor learning principles, have been found to be effective for solving these problems. With these rehabilitation approaches, it is aimed to develop the ability of the person to meet the task and environmental demands and to realize the highest quality and the right function with maximum potential by consuming the least energy in different environmental conditions of different tasks. "Task-oriented training" may be one of the most effective among the evidence-based rehabilitation approaches for these goals.

The purpose of this study is to determine the effect of "Task-Oriented Training" on the physical and cognitive functions in patients with multiple sclerosis.

详细描述

The study was designed as a randomized, controlled, single-blind trial. The patients will be randomly assigned to two groups, the "task-oriented training" group, and the control group. "Task-oriented training" consisting of 10 different motor tasks including lower extremity and upper extremity activities will be applied to the training group twice a week for 6 weeks. The control group will be taught relaxation exercises and will be asked to perform the exercises 2 times for 6 weeks at home.

Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The pre-training and post-training measurements of groups will be compared with the Wilcoxon Test. The significance level was set at p< 0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

To ensure blinding, the assessor physiotherapist will not be aware of the arm to which the subjects belong.

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

  • •Participants who are ambulatory and volunteer to participate to the study, in a stable phase of the disease, without relapses in the last 3 month, with an EDSS between 2-5,5.

排除标准

  • •Participants who have orthopedic, vision, hearing, or perception problems
  • •Patients who have any cardiovascular or pulmonary disease in which exercise is contraindicated

研究组 & 干预措施

Control group

No Intervention

The control group will be taught relaxation exercises and will be asked to perform.

Task-oriented training

Experimental

"Task-oriented training" consisting of 10 different motor tasks will be applied.

干预措施: Task-oriented training (Other)

结局指标

主要结局

cognitive function

时间窗: thirty minutes

The Brief Repeatable Battery of Neuropsychological Tests consists of the Selective Reminding Test, the 10/36 Spatial Recall Test, the Symbol Digit Modalities Test, the Paced Auditory Serial Addition Test and the Word List Generation Test.

Walking ability

时间窗: Five minutes

The 12-item Multiple Sclerosis Walking Scale (MSWS-12) is a self-assessment scale. During the last 2 weeks 12 problems that can occur during walking due to MS are evaluated (1:no limitation, 5:extreme limitation).

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.

upper extremity function

时间窗: ten minutes

9-Hole Peg Test

mobility

时间窗: ten minutes

Timed Up and Go Test

Gait Assessment

时间窗: ten minutes

The Functional Gait Assessment is a 10-item walking-based balance test, with each item scored 0 to 3. The high score shows that the balance is better.

次要结局

  • Balance Scale(ten minutes)
  • Fatigue Impact(Five minutes)
  • Balance Confidence(Five minutes)
  • Fatigue Severity(five minutes)
  • Physical Activity(ten minutes)
  • Neuropsychological Questionnaire(one minute)

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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