Evaluation of Early Standardized Task-Specific Training (ESTT) (ESTT)
2015年9月1日 更新者：Karen McCain、University of Texas Southwestern Medical Center
Evaluation of Early Standardized Task-Specific Training (ESTT) in Persons With Acute Stroke
A. Specific Aims:
1. There is one specific aim of this study. The aim is to evaluate the effectiveness of early standardized task-specific training (ESTT) in persons with acute stroke.
B. Hypothesis:
1. It is our hypothesis that subjects who receive ESTT will walk faster and more symmetrically than published reports of gait outcomes in persons with stroke.
研究概览
详细说明
It is our contention that gait recovery after stroke is impacted by the interventions that are acutely utilized during training.
There is not a consensus about how to most effectively train individuals after stroke.
It is clear, however, that most persons are left with significant and often debilitating gait dysfunction after stroke so there is an urgent need to find more effective therapeutic methods.
研究类型
介入性
注册 (实际的)
12
阶段
- 不适用
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
-
-
Texas
-
Austin、Texas、美国、78705
- St. David's Rehabilitation Hospital
-
Dallas、Texas、美国、75246
- Baylor Institute for Rehabilitation - Dallas
-
Dallas、Texas、美国、75247
- Baylor Institute for Rehabilitation - Northwest
-
Frisco、Texas、美国、75034
- Baylor Institute for Rehabilitation - Frisco
-
-
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
16年 至 80年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Recent stroke (less than 6 weeks)
- Able to give conformed consent or have family member who can give consent
- first time stroke OR complete recovery from prior stroke
Exclusion Criteria:
- non-ambulatory before onset of stroke
- bilateral stroke
- presence of severe cardiac problems
- other co-morbidities which would affect gait training (i.e. amputation, spinal cord injury, traumatic brain injury, etc.)
- recent myocardial infarct (within 4 weeks)
- any uncontrolled health condition for which exercise is contraindicated
- severe lower extremity joint disease/pathology that would interfere with gait training
- subjects with BMI greater than 40
- significant cognitive impairment
- age greater than 80 years or less than 16 years
- able to complete 5 or more full heel raises with the affected ankle in standing with the knee extended with no more than one or two fingers on support surface for balance
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？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：early standardized task training
Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.
|
Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment
大体时间：This will be done at the time of discharge from inpatient rehabilitation (the initial assessment point of the study) and at 6-months post enrollment.
|
Computerized gait analysis is done by a mat system (GAITRite) that electronically calculates the velocity.
|
This will be done at the time of discharge from inpatient rehabilitation (the initial assessment point of the study) and at 6-months post enrollment.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study.
大体时间：This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
|
The Stroke Rehabilitation Assessment of Movement (STREAM) is a test of motor recovery after stroke.
There are 3 subsections of the test, an upper extremity section, a lower extremity section and a mobility section.
Each section is scored independently and is normed to 100 points.
Each of the 3 sections is then combined into a total overall function score which is also normed to 100.
Therefore, a score of 100 represents full recovery whereas a score of 50 represents about 50% recovery from the stroke.
|
This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment
大体时间：This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
|
The 6-Minute Walk Test is a test of walking endurance and walking velocity.
|
This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment
|
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。
调查人员
- 首席研究员：Karen J McCain, PT, DPT, NCS、UT Southwestern Medical Center
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
2012年8月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2013年1月18日
首先提交符合 QC 标准的
2013年1月18日
首次发布 (估计)
2013年1月23日
研究记录更新
最后更新发布 (估计)
2015年10月1日
上次提交的符合 QC 标准的更新
2015年9月1日
最后验证
2015年9月1日
更多信息
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.