EMG biofeedback with AMES

描述(申请人提供)：该项目的长期目标是使用一种新的治疗方案和名为“Ames”的机器人设备恢复低功能中风患者的功能性运动，Ames是增强感觉的辅助运动的缩写。在Ames中--就像目前使用的那样--患者的患肢通过Ames机器人设备进行周期性移动，同时通过应用于拮抗肌肉的Ames肌肉振动器来增强运动感(S)。患者同时使用自主关节扭矩的生物反馈来辅助施加的运动。在一项I期临床试验(Cordo 2008)中，Ames被确定能有效地恢复低功能慢性中风受试者(中风后1年)的上肢和下肢的功能运动，其中几人瘫痪。在登记时，这些受试者中的大多数在受影响的手臂或腿部的力量都不超过正常的30%。尽管在治疗这些高度残疾的中风患者方面取得了成功，但如果关节瘫痪，Ames治疗通常不能恢复手指、手腕或脚踝的功能活动。在Ames治疗期间，对这些受试者进行了肌电记录，所有受试者都保留了自愿激活他们的瘫痪肌肉的能力。然而，由于这种肌肉活动非常弱，而且因为它与对抗性的共同收缩竞争，这些人无法抵消相反的力量来移动关节。这一拟议项目的目标是将肌电生物反馈纳入Ames设备和方案中，用于瘫痪中风患者，作为无法产生关节扭矩时关节扭矩生物反馈的替代方案。该项目第一阶段的重点是消除肌腱振动器引起的肌电记录中的电气和机械噪音，并开发原型软件，以测试Ames方案与肌电生物反馈相结合的可行性。第二阶段的目标是进一步开发与肌电生物反馈和肌肉振动相关的硬件和软件，并测试带有肌电生物反馈的AMES对手伸肌麻痹的中风患者的疗效。在第二阶段的申请中提出了三个具体目标。具体目标1是通过设计并将2通道肌电放大器集成到Ames设备中，进一步开发肌电生物反馈在Ames设备上的呈现，并使生物反馈更吸引患者。具体目标2是开发新的、更可靠和用户友好的肌肉振动技术，包括振动器本身及其定位机制。具体目标3是在3个地点(埃默里大学医学院、俄勒冈健康与科学大学和芝加哥康复研究所)对慢性截瘫中风患者进行随机对照临床研究，以测试肌电生物反馈治疗的疗效。公共卫生相关性：该项目针对手部伸展瘫痪的慢性中风患者亚群，他们保留了一些自愿激活‘瘫痪’肌肉的能力。我们早期的研究表明，在美国约400万患有慢性运动障碍的中风患者中，多达三分之一患有手部和/或脚部瘫痪。这项拟议的技术旨在逆转瘫痪关节的共同收缩，恢复功能性运动。这个第二阶段的项目将测试使用生物反馈与一种名为“Ames”的新治疗方案相结合来重新训练肌肉的效果，并将Ames治疗设备推向商业化的门槛。

DESCRIPTION (provided by applicant): The long-range goal of this project is to restore functional movement to low-functioning stroke patients using a novel therapeutic regimen and robotic device called "AMES," an acronym for Assisted Movement with Enhanced Sensation. In AMES-as it is currently used-the patient's affected limb is moved cyclically with the AMES robotic device while the sensation of motion is enhanced by an AMES muscle vibrator applied to the antagonist muscle(s). The patient simultaneously assists with the imposed movement using biofeedback of voluntary joint torque. In a Phase I clinical trial (Cordo 2008), AMES was determined to be effective at restoring functional movement in both upper and lower extremities of low-functioning chronic stroke subjects (>1 yr post-stroke), several of which were plegic. At enrollment, most of these subjects had no more than 30% of normal strength in the affected arm or leg. Despite this success at treating these highly disabled stroke subjects, AMES treatment usually did not restore functional movement at the fingers, wrist, or ankle if the joint was plegic. EMG recordings were taken of these subjects during AMES therapy, and all retained the ability to activate voluntarily their 'plegic' muscles. However, because this muscle activity was so weak, and because it competed with antagonistic co-contraction, these individuals were unable to counteract the opposing forces in order to move the joint. The goal of this proposed project is to incorporate EMG biofeedback into the AMES device and regimen for plegic stroke patients, as an alternative to joint torque biofeedback when no joint torque can be produced. Phase I of this project focused on eliminating electrical and mechanical noise in EMG recordings caused by the tendon vibrators, and on prototyping software to test the feasibility of combining the AMES regimen with EMG biofeedback. The goal of Phase II is to further develop the hardware and software associated with EMG biofeedback and muscle vibration, and to test the efficacy of AMES with EMG biofeedback on stroke patients with hand extensor plegia. There are 3 specific aims proposed in this Phase II application. Specific Aim 1 is to develop further the presentation of EMG biofeedback on the AMES device by designing and integrating a 2-channel EMG amplifier into the device and making the biofeedback more engaging to patients. Specific Aim 2 is to develop new, more reliable and user-friendly technology for muscle vibration, including the vibrator itself and its positioning mechanism. Specific Aim 3 is to test the efficacy of AMES with EMG biofeedback at 3 sites (Emory University School of Medicine, Oregon Health & Sciences University, and the Rehabilitation Institute of Chicago) in a randomized, controlled clinical study of 64 chronic plegic stroke patients. PUBLIC HEALTH RELEVANCE: This project addresses a sub-group of chronic stroke patients with hand plegia in extension, but who retain some ability to activate voluntarily the 'plegic' muscles. Our earlier studies suggest that as many as a third of the approximately 4 million stroke victims in the US with chronic motor disabilities have hand and/or foot plegia. The proposed technology is designed to reverse co-contraction at plegic joints and to restore functional movement. This Phase II project will test the efficacy of using biofeedback to retrain muscles in conjunction with a new therapeutic regimen called "AMES," and to bring the AMES therapy device to the threshold of commercialization.