Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation
2015年2月10日 更新者：Chang Gung Memorial Hospital
Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation: Effects on Motor Control, Motor Impairment, Daily Function and Community Reintegration
This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with distributed constraint-induced therapy or with robot-assisted Bilateral training.
研究概览
地位
撤销
条件
详细说明
Two theory-based, task-oriented approaches are distributed CIT (dCIT) and robot-assisted Bilateral training(BAT).
CIT/dCIT involves massed practice of the affected arm and restraint of the unaffected arm.
BAT involves repetitive practice of symmetrical bilateral movements on robot.
Both are evident to improve motor performance, motor control or daily function in high functioning patients.
These dCIT and BAT have their own limitations for motor-deficit rehabilitation after stroke, i.e.
only appropriate for high-functioning or mildly motor impaired patients.
Functional electrical therapy, an innovative technology, is proposed as an adjunct to these behavioral approaches to assist in movement execution.
Functional electrical therapy is used to increase the electric activity of muscles for movement and the active range of motion in low functioning patients.
Combining functional electrical therapy into CIT or BAT may extend the utility of these two behavioral approaches beyond patients with mild motor deficits and could expedite the progress of motor recovery.
This project attempts to perform a randomized controlled trial to verify the efficacy and motor control mechanism of the proposed combined functional electrical therapy with dCIT or with BAT.
研究类型
介入性
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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Taoyuan County、台湾
- Chang Gung Memorial Hospital
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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:
- The onset duration more than 6 months
- An initial upper extremity subsection of the Fugl-Meyer Assessment score of 33 to 52 indicating moderate or moderate-to-mild movement impairment
- No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
- The availability of caregiver for assistance during the 6-hour restraint time of unaffected extremity per day
- No balance problems sufficient to compromise safety when wearing the project's constraint device with the assistance of the caregiver
- Considerable nonuse of the affected upper extremity (an AOU score < 2.5 of Motor Activity Log)
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：Combined dCIT with FET
Combined distributed constraint induced therapy with functional electrical therapy
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This dCIT group focuses on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected upper extremity in functional tasks 1.5 hours/weekday, for 4 weeks.
The level of challenge will be adapted based on patient ability and improvement during training.
Patients will be encouraged to initiate the designed therapeutic functional activities.
其他名称：
其他名称：
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实验性的：Combined BAT with FET
Combined bilateral arm treatment with functional electrical therapy
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其他名称：
The BAT group concentrates on the simultaneous movements of both the affected and unaffected upper extremity on robot for 1.5 hours/day, 5 days/week for 4 weeks.
其他名称：
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有源比较器：Control intervention group
Control intervention
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The conventional intervention group is designed to control for the duration and intensity of patient-therapist interactions and therapeutic activities (1.5 hours/day, 5 days/week, for 4 weeks).
Therapy in the control intervention group will involve training for coordination, balance, and movements of the affected upper extremity, as well as compensatory practice on functional tasks with the unaffected upper extremity or both upper extremities.
其他名称：
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实验性的：dCIT
distributed constraint induced therapy
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This dCIT group focuses on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected upper extremity in functional tasks 1.5 hours/weekday, for 4 weeks.
The level of challenge will be adapted based on patient ability and improvement during training.
Patients will be encouraged to initiate the designed therapeutic functional activities.
其他名称：
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实验性的：BAT
bilateral arm treatment
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The BAT group concentrates on the simultaneous movements of both the affected and unaffected upper extremity on robot for 1.5 hours/day, 5 days/week for 4 weeks.
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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Movement time (MT)
大体时间：Baseline and change from baseline in MT at 4 weeks
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The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell.
MT is the interval between movement onset and offset.
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Baseline and change from baseline in MT at 4 weeks
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Total displacement (TD)
大体时间：Baseline and change from baseline in TD at 4 weeks
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The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell.
TD refers to the path of a hand in three-dimensional space and is a measure of trajectory smoothness.
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Baseline and change from baseline in TD at 4 weeks
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Percentage of peak velocity (PPV)
大体时间：Baseline and change from baseline in PPV at 4 weeks
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The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell.
The PPV reflects the duration of the acceleration phase relative to the deceleration phase and indicates the type of movement strategy selected for a motor action.
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Baseline and change from baseline in PPV at 4 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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Fugl-Meyer 评估 (FMA)
大体时间：基线、2 周时 FMA 基线的变化以及 4 周时 FMA 基线的变化
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FMA 的 UE 分量表（最大
66 分）使用 3 点顺序量表来评估运动障碍。
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基线、2 周时 FMA 基线的变化以及 4 周时 FMA 基线的变化
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机动活动日志 (MAL)
大体时间：基线、2 周时 MAL 的变化和 4 周时 MAL 的变化
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MAL 是对患者进行的半结构化访谈，使用 6 点顺序量表评估受影响上肢在 30 项重要日常活动中的使用量 (AOU) 和运动质量 (QOM)。
分数越高表示性能越好。
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基线、2 周时 MAL 的变化和 4 周时 MAL 的变化
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能力手问卷
大体时间：基线、2周ABILHAND问卷变化、4周ABILHAND问卷变化
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ABILHAND 问卷是一份包含 56 项手动活动的清单，它使用 3 点序数量表来衡量执行日常双手活动的主观感知难度。
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基线、2周ABILHAND问卷变化、4周ABILHAND问卷变化
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Medical Research Council scale (MRC)
大体时间：Baseline, change from baseline in MRC at 2 weeks, and change from baseline in MRC at 4 weeks
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The MRC scale examines the muscle strength of the affected arm and is reliable measurement with score ranged from 0 (no contraction) to 5 (normal power).
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Baseline, change from baseline in MRC at 2 weeks, and change from baseline in MRC at 4 weeks
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Modified Ashworth Scale (MAS)
大体时间：Baseline, change from baseline in MAS at 2 weeks, and change from baseline in MAS at 4 weeks
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The MAS scale is an ordinal scale (0-5 points) assessing spasticity of skeletal muscle in UE.
A higher score indicating more spasticity.
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Baseline, change from baseline in MAS at 2 weeks, and change from baseline in MAS at 4 weeks
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MYOTON-3
大体时间：Baseline, change from baseline in MYOTON-3 at two weeks, and change from baseline in MYOTON-3 at 4 weeks
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Assessment of the functional state of skeletal muscle was carried out using myometric measurements with the MYOTON-3 device.
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Baseline, change from baseline in MYOTON-3 at two weeks, and change from baseline in MYOTON-3 at 4 weeks
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Reintegration of Normal Living Index (RNL)
大体时间：Baseline, change of RNL at 2 weeks, and change of RNL at 4 weeks
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The RNL is used to measure the satisfaction with community reintegration.
It scores on a 4-point ordinal scale, with higher scores indicating a higher level of satisfaction.
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Baseline, change of RNL at 2 weeks, and change of RNL at 4 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：Ching-yi Wu, ScD、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
2012年1月1日
初级完成 (实际的)
2013年3月1日
研究完成 (实际的)
2013年3月1日
研究注册日期
首次提交
2012年1月30日
首先提交符合 QC 标准的
2012年1月30日
首次发布 (估计)
2012年2月1日
研究记录更新
最后更新发布 (估计)
2015年2月11日
上次提交的符合 QC 标准的更新
2015年2月10日
最后验证
2014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.