Functional Connectivity & Stimulation-enhanced Therapy Post Stroke
2019年3月1日 更新者：Na Jin Seo、Medical University of South Carolina
Brain Functional Connectivity & Sensory Stimulation-enhanced Therapy Post Stroke
After stroke, it is common for individuals to experience hand impairment.
This deficit can severely restrict functional ability and independence.
Recovery of hand function following stroke is highly variable.
In this study, the investigators will use brain imaging to predict individual response to treatment.
Survivors of stroke will receive upper extremity therapy while they concurrently receive imperceptible vibration to the wrist aimed to enhance therapy outcomes.
研究概览
详细说明
The ability to predict individuals' responses to treatment can enable effective allocation of a treatment to likely responders.
The long-term goal is to determine whether acute changes in brain functional connectivity immediately after one treatment session can predict ultimate gains in motor function after completing multiple treatment sessions.
The objective of this study is to determine feasibility and to examine association between change in brain functional connectivity after one session and motor gains after completion of all treatment sessions.
This study is a prospective single-cohort longitudinal study.
The treatment is task-practice therapy (3d/wk, 18-session) accompanied with concurrent imperceptible wrist vibration that is intended to prime the cortical sensorimotor network and enhance hand functional recovery in chronic stroke survivors.
Hand function will be assessed before/after therapy and at 1-month follow-up.
Connectivity will be assessed using fMRI and EEG before and after a treatment session.
研究类型
介入性
注册 (实际的)
5
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
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South Carolina
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Charleston、South Carolina、美国、29403
- Medical University of South Carolina
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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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age = 18 or older
- At least 6 months post-stroke
- Moderate upper limb impairment with the ability to participate in hand task practices
- Fingertip touch sensory deficits (e.g., Monofilament>2.83, 2-point discrimination>5mm, sense of numbness, tingling)
Exclusion Criteria:
- Complete upper limb deafferentation
- Rigidity (Modified Ashworth Scale=5)
- Botulinum toxin injection within 3 months prior to enrollment or during enrollment
- Brainstem stroke
- Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
- Concurrent upper extremity rehabilitation therapy
- Language barrier or cognitive impairment that precludes following instructions or providing consent
- MRI incompatible.
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 |
|---|---|
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实验性的：therapy + vibration
Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.
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Standardized hand therapy program
Peripheral vibration applied to the wrist skin at an imperceptible level
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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 |
|---|---|---|
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Mean Change in Hand Motor Function
大体时间：Baseline to approximately 1 week after the completion of 18 therapy sessions.
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Change in hand motor function as measured by the Box and Block Test.
The test measures the number of blocks that a participant moves within one minute.
The scale ranges from 0 to a positive number.
Higher numbers represent better outcomes.
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Baseline to approximately 1 week after the completion of 18 therapy sessions.
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Mean Change in Hand Motor Function
大体时间：Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
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Change in hand motor function as measured by the Box and Block Test.
The test measures the number of blocks that a participant moves within one minute.
The scale ranges from 0 to a positive number.
Higher numbers represent better outcomes.
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Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean Change in Hand Motor Function
大体时间：Baseline to approximately 1 week after the completion of 18 therapy sessions.
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Change in hand motor function as measured by the Wolf Motor Function Test Time.
This test measures time to complete upper extremity movements in seconds.
More negative values represent a greater reduction in time, thus better outcomes.
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Baseline to approximately 1 week after the completion of 18 therapy sessions.
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Mean Change in Hand Motor Function
大体时间：Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
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Change in hand motor function as measured by the Wolf Motor Function Test Time.
This test measures time to complete upper extremity movements in seconds.
More negative values represent a greater reduction in time, thus better outcomes.
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Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
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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
- 学习椅：Steve Kautz, PhD、Medical University of South Carolina
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)
2018年3月7日
初级完成 (实际的)
2018年9月24日
研究完成 (实际的)
2018年9月24日
研究注册日期
首次提交
2018年3月5日
首先提交符合 QC 标准的
2018年3月15日
首次发布 (实际的)
2018年3月22日
研究记录更新
最后更新发布 (实际的)
2019年3月5日
上次提交的符合 QC 标准的更新
2019年3月1日
最后验证
2019年3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.
task-practice therapy的临床试验
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Medical University of ViennaMedical University of Graz尚未招聘
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Instituto Nacional de Cardiologia Ignacio Chavez未知
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University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的
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Abbott Medical Devices完全的