The Effects of Mirror Therapy on Upper Extremity in Stroke Patients
2015年11月3日 更新者：Taipei Medical University Hospital
The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people with stroke.
研究概览
地位
完全的
条件
详细说明
55% to 75% of people after stroke have a paretic arm that causes motor impairment.
Among novel rehabilitation interventions, MT was found to be beneficial and comparatively low-cost.
MT reduced motor impairment possibly in part of recruiting the premotor cortex or balancing the neural activation within the primary motor cortex toward the affected hemisphere.
However, the benefits in certain aspects of outcomes are under debate.
Another treatment, MG, can be used to normalize muscle tone, suppress muscle spasticity, enhance residual volitional activity of hand and arm, or even increasing walking speed.
In addition, providing MG stimulation might result in plastic changes in the primary motor cortex, and induced a long-lasting modulated effect on motor cortical excitability.
The possible mechanism of brain plasticity underlying MG is collective with the mechanism behind the MT.
Adding MG to MT might augment the cortical reorganization.
In sum, combining MT with MG may supplement the disadvantage or uncertain effects of MT and broaden the benefited outcomes.
研究类型
介入性
注册 (实际的)
60
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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New Taipei City、台湾、23561
- Shuang-Ho Hospital, Taipei Medical University
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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
20年 至 75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:
- The onset duration more than 3 months
- Demonstration of Brunnstrom stage equal to or above stage III of the affected upper extremity
- No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
- No serious visual and visual-perception impairments
- No concurrent participation in other drug or rehabilitation research
- No serious attention deficits
- No excessive spasticity in any of the joints of the affected UL exclusion criteria
Exclusion Criteria:
- Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
- Excessive pain in any joint that might limit participation
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：阶乘赋值
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Mirror therapy
mirror box training with or without sham mesh glove stimulation
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This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session.
The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks.
MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.
其他名称：
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实验性的：Mirror therapy + Mesh glove stimulation
Mirror therapy combined with mesh glove stimulation
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This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session.
The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks.
MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.
其他名称：
The MG is a two-channel electrical stimulator providing synchronous or reciprocal sensory stimulation with variant amplitudes.
其他名称：
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有源比较器：Controlled intervention
conventional interventions
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Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach
其他名称：
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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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Fugl-Meyer Assessment (FMA)
大体时间：Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
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The upper-extremity subscale of the FMA contains 33 items to assess motor impairment.
Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly).
The sub-score of a proximal shoulder/elbow (0-42) and a distal hand/wrist (0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements.
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Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
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Wolf Motor Function Test (WMFT)
大体时间：Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
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Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
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Accelerometers
大体时间：Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
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The accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory.
Acceleration is sampled at 10 Hz and summed over a user- specified epoch.
The recording epoch in this study is 2 seconds; recording capacity is approximately 72 hours.
A "threshold-filter" will be applied to the raw recordings to obtain an accurate measure of the duration of arm movement.
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Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
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revised Nottingham Sensory Assessment (rNSA)
大体时间：Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
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The rNSA examines the sensory function of the affected arm and includes tactile sensation (0=Absent, 1=Impaired, 2=Normal), proprioception (0=Absent, 1=Appreciation of movement sense, 2=Direction of movement sense, 3=Joint position sense), and stereognosis (0=Absent, 1=Impaired, 2=Normal) subtests.
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Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
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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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Kinematic analyses
大体时间：Baseline, change from baseline in kinematic parameters at 4 weeks
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A 7-camera motion-analysis system (VICON MX, Oxford Metrics Inc., Oxford, UK) was used.
The variables of reaction time (second), movement time (second), total displacement (mm), peak velocity (mm/second), percentage of peak velocity, joint recruitments (degree), and maximum shoulder and elbow cross-correlation were collected.
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Baseline, change from baseline in kinematic parameters at 4 weeks
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Motor Activity Log (MAL)
大体时间：Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
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The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale.
Higher scores indicate superior amount and quality of use in affected upper extremity.
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Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
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Semmes-Weinstein monofilaments
大体时间：Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
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The Semmes-Weinstein monofilaments is used for measuring diminishing and returning cutaneous sensation.A nylon 'string' is specifically calibrated in stiffness to represent a baseline level of sensation that can be considered 'the line' between having neuropathy and having normal sensation.
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Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
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Functional Independence Measure (FIM)
大体时间：Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
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The FIM consists of 18 items grouped into 6 subscales.
Each item is rated from 1 to 7 (max.
score 126) based on the required level of assistance to perform the tasks.
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Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
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Stroke Impact Scale version 3.0 (SIS 3.0)
大体时间：Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
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The SIS is a stroke-specific instrument of health related quality of life and contains 59 items measuring 8 domains.
Items are rated on a 5- point Likert scale with lower scores indicate greater difficulty in task completion during the past week.
Aggregate scores, ranges from 0 to 100, are generated for each domain.
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Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
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8-OHdG
大体时间：Baseline, change from baseline in 8-OHDG at 4 weeks, change from baseline in 8-OHDG at 16 weeks, change from baseline in 8-OHDG at 28 weeks
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Urinary 8-OHdG is a stable and integral biomarker of oxidative DNA damage.About 10 mL to 15 mL urine samples of the patients will be collected in the centrifugal tubes before and after rehabilitation interventions.
The samples will be transported with dry ice under 4°C and preserved in a -80°C refrigerator before analysis.
A highly sensitive and selective method, using isotope- dilution liquid chromatography with tandem mass spectrometry (LC/MS/MS), will be used to determine the urinary 8-OHdG levels.
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Baseline, change from baseline in 8-OHDG at 4 weeks, change from baseline in 8-OHDG at 16 weeks, change from baseline in 8-OHDG at 28 weeks
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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
- 首席研究员：Keh-chung Lin, ScD、School of Occupational Therapy, College of Medicine, National Taiwan University
- 首席研究员：Tsan-hon Liou, PhD、Shuang-Ho Hospital, Taipei Medical University
- 首席研究员：Ching-yi Wu, ScD、Department of Occupational Therapy, College of Medicine, Chang Gung 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
2010年9月1日
初级完成 (实际的)
2014年5月1日
研究完成 (实际的)
2014年5月1日
研究注册日期
首次提交
2012年7月27日
首先提交符合 QC 标准的
2012年8月2日
首次发布 (估计)
2012年8月3日
研究记录更新
最后更新发布 (估计)
2015年11月5日
上次提交的符合 QC 标准的更新
2015年11月3日
最后验证
2012年11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.