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Effects of Two Different Kinds of Exercise on Stroke Rehabilitation

Effects of Unilateral and Bilateral Training on Motor Function in Chronic Stroke

This study will compare the effectiveness of unilateral versus bilateral exercise training for recovering movement abilities in chronic stroke patients. After a stroke, some people have improved their movement ability by exercising the arm affected by the stroke. Others have improved by exercising both arms together. This study will compare these two kinds of exercise to see which might work best.

Healthy volunteers and people who have had a stroke more than 6 months ago may be eligible for this study. Stroke patients must have some weakness in their stroke-affected arm. All participants must be 18 years of age or older. Candidates are screened with a clinical and neurological examination. Women who can become pregnant have a pregnancy test. Stroke patients have a magnetic resonance imaging (MRI) study of the brain if they have not had one in the last year.

Participants undergo the following tests and procedures:

MRI: This procedure uses a magnetic field and radio waves to produce images of body tissues and organs. The subject lies on a table that slides into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking sounds that occur during the scanning process. The procedure lasts about 45 minutes, during which time the subject must lie still for up to 30 minutes.

Testing sessions: There are six test sessions - two to familiarize the subject with the reaching test, two to do the reaching test plus transcranial magnetic stimulation (TMS) before and after an exercise session, and two to do the reaching test plus TMS one day after the exercise session. The sessions are on consecutive days, with a 1-week break after session 3. The procedures involved are:

  • Reaching test: The subject responds as quickly as possible to a "GO" signal presented on a computer monitor by performing a reaching movement with his or her arm. The activity from the arm muscles is recorded using surface electrodes. During this test, a questionnaire is used to determine the subject's attention, fatigue, and mood.
  • TMS: For this test, a wire coil is held on the scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click and feel a pulling sensation on the skin under the coil. The effect of TMS on the muscles is detected with small metal disk electrodes taped onto the skin of the arms. The subject performs the reaching test while TMS is delivered at various times after getting the "GO" signal.
  • Arm exercises: The subject is seated in front of an exercise device that has two handles that slide forward and backward along a set of tracks. The subject is asked to slide either one or both handles back and forth repeatedly, alternating 5 minutes of arm exercise with 5 minutes of rest for 30 minutes.

研究概览

地位

完全的

详细说明

Objective:

It has been proposed that individuals with stroke may benefit to a greater degree by training with both arms simultaneously than by training with the paretic arm alone. The purpose of this protocol is to identify the extent and the mechanisms of paretic arm performance improvement after a single session of bilateral arm training compared to a single session of unilateral paretic arm training in individuals with moderate-severity chronic stroke.

Study population:

The study population will consist of individuals with chronic stroke.

Design:

A single-blinded, counterbalanced, crossover design will be used.

Outcome measures:

Endpoint measures will include paretic arm peak acceleration and disinhibition of the stroke-affected cortical hemisphere as measured by transcranial magnetic stimulation (TMS) in the context of a reaching task. These measures will be compared after a unilateral vs. a bilateral arm training session in individuals with chronic stroke.

研究类型

观察性的

注册 (实际的)

24

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Maryland
      • Bethesda、Maryland、美国、20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

  • INCLUSION CRITERIA:

Individuals with Chronic Stroke (n=40):

We will include individuals at least 6 months post thromboembolic non-hemorrhagic hemispheric or hemorrhagic hemispheric lesion. We will select individuals who initially had severe hemiparesis but who recovered to the point of having moderate motor impairment. Individuals with moderate motor impairment will be defined by a Fugl-Meyer score of at least 30, and the inability to actively extend the paretic wrist and fingers at least 20 degrees. Assessment of severity of initial hemiparesis will be taken either from patient report or medical records.

We would also like to study a smaller group (n=10) of individuals with mild motor impairment due to stroke. Individuals with mild motor impairment will be defined by an Upper Extremity Fugl-Meyer score of 50 or greater (maximum score = 66), and the ability to actively extend the paretic wrist and fingers 20 degrees or more. We will also enroll 10 healthy volunteers.

EXCLUSION CRITERIA:

Healthy Volunteers:

  • History of alcohol or drug abuse or psychiatric illness, including depression.
  • History of neurological disorder or disease, including epilepsy.
  • History of orthopedic injury or disorder affecting the upper extremities.
  • Less than 18 years of age.
  • Have a pacemaker, implanted pumps or stimulators, or metal objects inside the eye or skull.

Individuals with Chronic Stroke (Moderate and Mild Impairment Groups):

  • Unable to perform the task (rapid forward reaching task) with the affected arm.
  • History of alcohol or drug abuse or psychiatric illness,
  • History of neurological disorder or disease, including epilepsy.
  • History of orthopedic injury or disorder affecting the upper extremities.
  • Less than 18 years of age.
  • Cerebellar or brainstem lesions.
  • Severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, arthritic joint deformity, active cancer or renal disease).
  • Taking medications that act primarily on the central nervous system.
  • Pregnancy - if MRI was not performed within the past 6 months and therefore needs to be attained.
  • Serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less) that would prevent their ability to give informed consent and/or perform the study tasks.
  • Have a pacemaker, implanted pumps or stimulators, or metal objects inside the eye or skull.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年4月13日

研究完成

2011年1月14日

研究注册日期

首次提交

2005年4月16日

首先提交符合 QC 标准的

2005年4月16日

首次发布 (估计)

2005年4月18日

研究记录更新

最后更新发布 (实际的)

2017年7月2日

上次提交的符合 QC 标准的更新

2017年6月30日

最后验证

2011年1月14日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 050142
  • 05-N-0142

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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