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临床试验/NCT02092662
NCT02092662已完成不适用

Objective Assessment of Upper Extremity Functioning of Stroke Patients Before and After Rehabilitation

Carmeli Eli1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
试验地点
1
主要终点
Fugl-Meyer Assessment.

研究概览

简要总结

The purpose of this study is to evaluate by objective measures the improvement in upper extremity functioning, as reflection of motor learning, in stroke patients in the sub acute phase. The investigators hypothesize that the improvements in daily functioning are partially due to compensation strategies and partially due to motor learning.

详细描述

Background: Most stroke patients continue to suffer from upper extremity motor deficiencies even after prolonged and intense rehabilitation in hospital. Even though guidelines and other studies recommend to apply a rehabilitation programs as patient reception. As opposed to that there is a scarce evidence for the efficacy of the rehabilitation.

Objectives: To evaluate by objective measures the improvement in motor performance of the upper extremity of stroke patients in the sub acute period. Secondary objective is to describe the correlation between proximal and distal motor deficiencies of the upper extremity.

Hypothesis: Patients will show better hand performance at the end of hospitalization. Part of it can be attributed to the rehabilitation and part to a spontaneous recovery. Correlation will be found for proximal and distal upper extremity motor deficiencies.

Methods:

Trial began only after the IRB research approval. All treatment sessions will implemented by the physical and occupational staff of the hospital. Assessments for the measures will be carry out by a certified physical therapist which is coinvestigator. The coinvestigator collect the raw data for analysis in Excel and than in SPSS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of cerebral stroke with upper extremity hemiparesis
  • Ability to understand simple orders

排除标准

  • Other orthopedic pathology
  • Bilateral Paresis
  • Other neurologic pathology
  • sensory aphasia

结局指标

主要结局

Fugl-Meyer Assessment.

时间窗: T1 at the beginning of the hospital stay and folloew up at T2 one month later.

zero to 66 points scale, measuring the impairment level of the upper extremity. Zero indicates a high level of impairment or minimum hand motor function, while 66 points indicates an increased motor function which is similar to normal upper extremity function.

Muscle Onset Time.

时间窗: the study group was assessed T1 at the beginning of the hospital stay and follow up at T2 one month later. The control group assessed for the the time onset and compared to the study group at T1

Assessed by surface electromyography device. The time period it takes the muscle to be activated and contract from a voice prompting is measured. Shorter time onset probably charcterized healthy people compared to patients after a stroke.

次要结局

  • Muscle Co-activation Index.(T1 at the beginning of the hospital stay and folloew up at T2 one month later.)
  • % Maximum Voluntary Contraction.(The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average.)
  • Handwriting Off-paper Time.(T1 at the beginning of the hospital stay and folloew up at T2 one mont...)
  • Handwriting Velocity(T1 at the beginning of the hospital stay and follow up at T2 one month later.)
  • Handwriting Pressure.(T1 at the beginning of the hospital stay and folloew up at T2 one mont...)

研究者

发起方
Carmeli Eli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Carmeli Eli

Professor

University of Haifa

研究点 (1)

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