Improving Arm and Hand Functions in Chronic Stroke (CIHR 2012-2015)
2016年8月3日 更新者：Dr. Deirdre Dawson、Baycrest
Examination of Therapeutic Intervention Methods on the Brain Recovery
Improving arm and hand function after stroke has been difficult to achieve within the rehabilitation service provided in the acute stage often due to the limited resource in health care.
While spontaneous recovery plateaus after 6 months, the prolonged disability affects quality of life and social participation in stroke survivors.
This study is aimed at improving chronic motor impairment arm and hand impairment by providing the intervention with intensive training schedule.
This study will compare two types of rehabilitation intervention using a randomized controlled trial.
Measurements also will be taken on various brain functions non-invasively to help discover how each of the intervention strategies works differently to repair the brain.
研究概览
详细说明
After unilateral stroke, incomplete recovery of arm and hand movement is common and its long-lasting negative effects include increased care giving costs and overall reduced quality of life.
Recent evidence suggests that a novel behavioral intervention could improve motor functions in sub-acute patients with added benefits in cognitive and brain functions.
However few studies have addressed whether chronic stage patients can also benefit from the intervention and how brain plasticity works over the course of rehabilitation.
This study will investigate the benefits of two types of intervention methods that are extendable for community-based intervention services in the future.
It also will examine changes in integrity of motions before and after the intervention.
Further comparisons between brain functions and structure will be made using magnetoencephalography (MEG) and magnetic resonance imaging (MRI), non-invasively.
These behavioural and physiological measures will inform the mechanisms of stroke recovery and training.
研究类型
介入性
注册 (实际的)
29
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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Ontario
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Toronto、Ontario、加拿大、M6A2E1
- Baycrest Centre for Geriatric Care
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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:
- post-acute stroke patients with unilateral first-time MCA stroke sustained . (more than 6 months ago prior to the enrolment to the study).
- Patients' residual motor impairments in the affected hand and arm should be greater than stage 3 on the Chedoke McMaster scale.
Exclusion Criteria:
- Patients with moderate apraxia, aphasia or dementia, and patients with severe sensory loss in the paretic hand, severe language-communication disability, posture problems, involuntary movements, high-blood pressure, depression or other psychological disorders, metal in body that interferes with MEG and MRI measurements.
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：MSR - Music Supported Rehabilitation
Behavioral: Music Supported Rehabilitation
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Music Supported Rehabilitation -using musical exercises to improve hand and arm motor functioning.
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有源比较器：CU/ET
Experimental: CU/ET (Conventional Upper Extremity Therapy)
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-GRASP (Graded Repetitive Arm Supplementary Program-developed Janice Eng, PhD, PT/OT Jocelyn Harris, PhD, OT, Andrew Dawson, MD, FRCP, Bill Miller, PhD, OT) protocol will be used to improve arm and hand function in people living with stroke.
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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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Change in performance on Action Research Arm Test
大体时间：Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
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Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.
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Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
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Change in performance on Chedoke Arm and Hand Inventory
大体时间：Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
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Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.
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Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
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Change in status on Stroke Impact Scale
大体时间：Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
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Changes in performance from baseline to post-intervention at 5 weeks, to post-intervention at 10 weeks, and to follow-up at 4 mos will be measured.
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Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
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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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Brain structure
大体时间：Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up
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Structural MRI
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Pre, post-5-weeks, post-10-weeks, and 4-month-follow-up
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Brain Function
大体时间：Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
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Brain functions related to sensory and motor systems assessed by MEG
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Baseline, post-5-weeks, post-10-weeks, and 4-month-follow-up
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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。
赞助
调查人员
- 首席研究员：Deirdre R Dawson, PhD、Baycrest
- 首席研究员：Bernhard Ross, PhD、Baycrest
- 首席研究员：Takako Fujioka, PhD、Stanford University
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11月1日
初级完成 (实际的)
2016年3月1日
研究完成 (实际的)
2016年3月1日
研究注册日期
首次提交
2012年11月1日
首先提交符合 QC 标准的
2012年11月5日
首次发布 (估计)
2012年11月6日
研究记录更新
最后更新发布 (估计)
2016年8月5日
上次提交的符合 QC 标准的更新
2016年8月3日
最后验证
2016年8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.
Music Supported Rehabilitation的临床试验
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Fondation Oeuvre de la Croix Saint-Simon撤销
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University of Alabama at BirminghamThe Craig H. Neilsen Foundation; Lakeshore Foundation完全的
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Assistance Publique - Hôpitaux de Paris尚未招聘疼痛 | 疼痛，术后 | 焦虑 | 胸外科 | 疼痛，胸部 | 术后焦虑
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IRCCS Eugenio Medea招聘中