用于中风康复的被动机器人：可行性研究
用于中风康复的被动机器人
The purpose of this study is to examine the feasibility and effectiveness of a novel, multimodal approach that combines passive devices with noninvasive neuromuscular stimulation for upper extremity rehabilitation after stroke.
研究概览
详细说明
About 800,000 individuals suffer from a stroke every year in the United States. The majority of stroke survivors often experience lingering deficits in upper extremity function. High-end robotic devices can improve outcomes and clinical productivity; however, these devices are expensive and bulky, making them not practical for many clinical or home environments. This study aims to evaluate the feasibility of low-cost non-motorized devices for stroke rehabilitation in a long-term intervention. The intervention will involve training with a table-top, semi-passive (i.e., no motors) exercise equipment called SepaRRo and commonly-used neuromuscular stimulation. The stimulation will be provided during functional activities using a custom controller (NeuRRoFES) to trigger stimulation. These instruments are designed to provide flexible, compliant assistance/resistance to improve upper extremity function and can be used in a home setting. The study will measure technical feasibility (e.g., qualitative survey, adherence, time on task, retention, ability to perform tasks) as well as clinical feasibility (i.e., changes in biomechanical, neurophysiological, and functional measures) of an intervention with these devices in stroke survivors. The findings aim to support the development of affordable, home-use rehabilitation systems for stroke patients.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Chandramouli Krishnan, PT, PhD
- 电话号码：7349364031
- 邮箱：mouli@umich.edu
研究联系人备份
- 姓名：Thomas E Augenstein, PhD
- 电话号码：7342320898
- 邮箱：tomaugen@umich.edu
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48108
- 招聘中
- University of Michigan - NeuRRo Lab
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首席研究员：
- Chandramouli Krishnan, PT PhD
-
接触：
- Thomas E. Augenstein, PhD
- 电话号码：(734) 936-4031
- 邮箱：tomaugen@umich.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18 to 75 years;
- Ischemic or hemorrhagic stroke confirmed by CT, MRI, or clinical criteria;
- No major deficits of sensation or proprioception;
Exclusion Criteria:
- Bilateral stroke
- Unable to think clearly and remember (Mini-Mental State Exam score < 22 and miniMOCA < 8);
- Uncontrolled Diabetes or Hypertension;
- Severe limitations of joint range of motion that will lead to inability of testing
- Severe spasticity and joint contractures that will lead to inability of testing
- Complete paresis with no possible movements
- Severe aphasia
- Any other medical condition that will significantly impact the study results
- Unable to obtain reliable motor evoked potentials
- Are pregnant or are actively trying to conceive
- Have a recent history of repeated fainting spells or syncope.
- Have a recent history of seizure (epilepsy) while on anti-seizure medication
- Have a recent history of skull fracture/head injury
- Have metal implants in the skull
- Have cardiac pacemakers
学习计划
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 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 |
|---|---|
|
实验性的：Robotic Intervention
Participants will receive upper extremity rehabilitation using SepaRRo and NeuRRoFES 2-5 times per week for 2-6 weeks |
Participants will perform functional movements (e.g., reach for targets) with their extremities. During movements, the devices will be used to assist or resist their motion. Participants may receive biofeedback of their movements to better engage them in training. Participants may receive assistance from the devices (including neuromuscular stimulation) and/or their less-impaired limb. |
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 |
|---|---|---|
|
Device Survey For Feasibility
大体时间：Post-intervention (immediately following last session of intervention)
|
Subjective feedback regarding feasibility of the device for training |
Post-intervention (immediately following last session of intervention)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Retention
大体时间：Post-intervention (immediately following last session of intervention)
|
Measure of how many participants completed intervention |
Post-intervention (immediately following last session of intervention)
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|
Adherence
大体时间：Post-intervention (immediately following last session of intervention)
|
Measure of percentage of sessions completed |
Post-intervention (immediately following last session of intervention)
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|
Upper extremity Fugl-Meyer Score
大体时间：Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively.
|
Changes in upper extremity Fugl-Meyer score from before the intervention (from baseline) to after its completion using publicly available scoring sheets. The Fugl-Meyer score is a measure of functional impairment and runs from 0 to 66 points, with higher numbers reflecting better outcome. |
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively.
|
|
Reachable workspace
大体时间：Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
Changes in reachable workspace from before the intervention (from baseline) to after its completion). The reachable workspace area will be measured with SepaRRo obtained from optical encoders mounted in the device. |
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
|
Voluntary hand opening
大体时间：Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
Changes in voluntary ability to open the hand from before the intervention (from baseline to after its completion). Voluntary hand opening will be measured with motion capture equipment. |
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
|
Action Research Arm Test Score
大体时间：Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
Changes in the Action Research Arm Test Score from before the intervention (from baseline) to after its completion using publicly available scoring sheets. The Action Research Arm Test is a measure of arm functional ability and runs from 0 to 57 points, with higher numbers reflecting better outcome. |
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
|
Box and Block (BBT)
大体时间：Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
Changes in functional measure of arm disability (BBT) from before the intervention (from baseline) to after its completion using publicly available scoring sheets. |
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
|
Hand Strength
大体时间：Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
Changes in force produced by the hand from before the intervention (from baseline) to after its completion as measured by force production recorded with a dynamometer |
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
|
Arm strength
大体时间：Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
Changes in force produced by the arm from before the intervention (from baseline) to after its completion as measured by force production recorded with a dynamometer |
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
|
Muscle coordination
大体时间：Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
Changes in muscle coordination of the upper extremity muscles as measured using surface electromyography between before the intervention (from baseline) to after its completion. |
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
|
Joint coordination
大体时间：Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
Changes in coordination of the upper extremity joints as measured motion capture between before the intervention (from baseline) to after its completion. |
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
|
Corticospinal excitability
大体时间：Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
Changes in corticospinal excitability of the upper extremity muscles as measured using surface electromyography and transcranial magnetic stimulation between before the intervention (from baseline) to after its completion |
Baseline and post-intervention measurements will be taken on separate days, within a week of the first and last sessions of the intervention, respectively
|
合作者和调查者
调查人员
- 首席研究员：Chandramouli Krishnan, PT, PhD、University of Michigan
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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