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临床试验/NCT05490628
NCT05490628Unknown不适用

The Effects of Cognitive Rehabilitation on Motor Performance, Balance and Fear of Falling in Stroke Patients

Istanbul University - Cerrahpasa (IUC)0 个研究点目标入组 24 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
24
主要终点
Montreal Cognitive Assessment

研究概览

简要总结

One of the most common complications in stroke patients is cognitive impairment. Cognitive impairment affects a large part of the life of stroke patients. However, the relationship between cognitive impairment and fear of falling in stroke patients has not been investigated in any study yet. Various treatment approaches have been developed to improve cognitive function. While some of these approaches focus on improving cognitive function, others aim to reach the maximum functional level with various compensation methods taught to the patient in the current cognitive situation. As a result of cognitive interventions, stroke patients' participation in daily life, adherence to treatment and quality of life increase. The aim of this study is to investigate the effects of cognitive interventions on motor performance, balance and fear of falling. This study will contribute to the literature by investigating these effects of cognitive rehabilitation.

详细描述

Participants will be randomized into two groups as control and experimental groups. The control group will receive traditional rehabilitation intervention, while the experimental group will receive additional cognitive intervention to traditional rehabilitation. Two groups will be evaluated before and after the study. Participants' motor performance, balance and fear of falling will be determined by evaluation criteria.

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
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • Having been diagnosed with stroke
  • The duration of the disease is in the range of 1-24 months
  • Having a score of 21 or lower on the mini mental state test
  • Having received 3 or more according to the Functional Ambulation Scale
  • Not having a vision problem that will affect the vision of the materials to be used during the treatment
  • Being able to communicate sufficiently to understand the simple orders given

排除标准

  • Having been diagnosed with bilateral stroke
  • Having a neurological disease other than the diagnosis of stroke
  • Development of aphasia after stroke

结局指标

主要结局

Montreal Cognitive Assessment

时间窗: through study completion, an average of 2 months

Developed to evaluate mild cognitive impairments, Montreal Cognitive Assessment assesses different cognitive abilities including executive functions, visuospatial skills, memory, language, attention concentration, abstract thinking, calculation and orientation. It takes about 10 minutes to administer and the highest total score that can be obtained from the test is 30. Accordingly, scores of 21 and above are considered normal.

Tinetti Balance & Gait Test

时间窗: through study completion, an average of 2 months

Tinetti Balance and Gait Scale is used to evaluate patients' balance and gait.

Fugl-Meyer Assessment

时间窗: through study completion, an average of 2 months

The Fugl-Meyer Assessment is used to evaluate any loss or abnormality in physiological, anatomical structure or function in motor function.

Falls Efficacy Scale International (FES-I)

时间窗: through study completion, an average of 2 months

FES-I is a self-report questionnaire that provides information on the level of anxiety about falls for 16 activities of daily living.

次要结局

  • The Timed Up & Go (TUG) Test(through study completion, an average of 2 months)
  • 10 meter walking test(through study completion, an average of 2 months)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rüstem Mustafaoğlu

Associate Professor

Istanbul University - Cerrahpasa (IUC)

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