Ischemic Conditioning as an Intervention to Improve Motor Function in Chronic Stroke
2020年4月10日 更新者:Matthew Durand、Medical College of Wisconsin
The investigators will test whether an intervention called ischemic conditioning can improve paretic leg motor function in chronic stroke subjects.
研究概览
详细说明
This study will study ischemic conditioning (IC) as an intervention to improve motor function post-stroke.
IC is a well studied, well tolerated intervention which has been shown to improve regional blood flow, motor neuron excitability and muscle function in multiple patient groups and in young, healthy subjects.
Because IC targets three physiological systems which are all affected by stroke, the investigators hypothesize that repeated bouts of IC will result in improved motor function of the paretic leg.
研究类型
介入性
注册 (实际的)
64
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
-
-
Wisconsin
-
Milwaukee、Wisconsin、美国、53233
- Marquette University
-
-
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 至 85年 (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:
- be between the ages of 18-85
- able to give informed consent
- be ≥ 6 months post diagnosis of unilateral cortical stroke and
- have residual leg paresis.
Exclusion Criteria:
- chronic low back or hip pain
- substance abuse
- head trauma in last 6 months
- neurodegenerative disorder
- any uncontrolled medical condition
- any condition where knee extension contractions are contraindicated
- people who are unable to follow multi step commands.
- people who cannot walk ≥ 10 ft without physical assistance.
- history of major psychiatric disorder
- participant has had a myocardial infarction in the last year
- participant has uncontrolled hypertension
- participant is unable to contract knee muscles
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:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Ischemic Conditioning
The investigators will perform ischemic conditioning on the paretic leg by inflating a blood pressure cuff to 225 mmHg to occlude blood flow to the leg for 5 minutes.
This will be repeated for 5 cycles, with 5 minutes of rest between each cycle.
The intervention will be performed for a maximum of 12 times within a 4 week period.
|
Inflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.
Maximum 12 sessions over 4 weeks.
|
假比较器:Sham
The investigators will perform sham ischemic conditioning on the paretic leg by inflating a blood pressure cuff to only 25 mmHg on the leg for 5 minutes.
This will be repeated for 5 cycles, with 5 minutes of rest between each cycle.
The intervention will be performed for a maximum of 12 times within a 4 week period.
|
Inflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times.
Maximum 12 sessions over 4 weeks.
|
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 |
---|---|---|
Leg Muscle Strength
大体时间:Within 1 year of admission into the study
|
Maximum voluntary contraction of the leg muscles, measured in Newton Meters, as assessed using a Biodex dynamometer.
|
Within 1 year of admission into the study
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Leg Muscle Fatigue
大体时间:Within 1 year of admission into the study
|
Duration the leg muscles can sustain contraction to a load level equal to 30% of a maximum voluntary contraction.
Measurement units will be seconds the contraction can be held, as assessed using a Biodex Dynamometer.
|
Within 1 year of admission into the study
|
Brachial Artery Flow Mediated Dilation
大体时间:Within 1 year of admission into the study
|
Percent dilation of the brachial artery
|
Within 1 year of admission into the study
|
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:Matthew J Durand, PhD、Medical College of Wisconsin
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 (实际的)
2016年5月1日
初级完成 (实际的)
2019年2月1日
研究完成 (实际的)
2019年7月1日
研究注册日期
首次提交
2017年3月23日
首先提交符合 QC 标准的
2017年3月23日
首次发布 (实际的)
2017年3月30日
研究记录更新
最后更新发布 (实际的)
2020年4月14日
上次提交的符合 QC 标准的更新
2020年4月10日
最后验证
2020年4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.