EMG Biofeedback with AMES

描述（由申请人提供）：该项目的长期目标是能够使用一种新的治疗方案和名为“AMES”的机器人设备有效地治疗瘫痪的中风患者，“AMES”是增强感觉辅助运动的首字母缩写。在AMES中，患者使用自主关节扭矩的生物反馈来辅助机器人装置的运动，同时通过肌腱振动来增强运动感。在一项临床前试验中，我们发现AMES可以有效地恢复大多数重度残疾慢性卒中患者的上肢和下肢功能运动（bbb20年事件）。在入组时，这些受试者的正常肢体力量排名<30百分位。尽管我们在治疗严重残疾的中风患者方面取得了成功，但AMES治疗并没有恢复因中风而完全瘫痪的关节（如手指、手腕和脚踝）的功能运动。然而，通过肌电图记录，我们发现大多数瘫痪性中风患者保留了主动激活“瘫痪”肌肉的能力。因为活动是如此的弱，它与对抗性痉挛和共同收缩竞争，这些个体无法向一个或另一个方向移动关节。该项目的目标是将肌电生物反馈纳入AMES治疗，作为扭矩生物反馈的替代方案，以有效治疗深度瘫痪中风患者。在第一阶段的申请中提出了两个具体目标。第一个具体目标是将肌电信号转换成图形显示器上有用的生物反馈。必须完成两项任务：(1)开发和测试软件，以低通滤波肌电信号，使带宽（~0- 2hz）与患者的努力相匹配；(2)在图形上显示2个激动剂和2个拮抗剂肌肉的活动，以一种直观的方式显示患者如何纠正他们的协同作用障碍。第二个具体目标是在肌腱振动的情况下进行肌电信号采集所必需的——振动器产生的机械和电子干扰必须在肌电信号记录中减少到不降低生物反馈信息含量的水平。具体目标2是将这种干扰降低到整个信号幅度的2%。我们建议探索一些机械工件和电子工件问题的替代解决方案，并在最小化成本的同时实现有效的解决方案。一旦我们在AMES设备上实现了有用的肌电生物反馈，该项目的第二阶段将在对照临床试验中测试该方法。该项目针对一个或多个关节完全瘫痪的慢性中风患者，但他们保留了一些自主激活“瘫痪”肌肉的能力。我们的初步研究表明，在美国500万慢性中风患者中，相当大比例的患者在一个或多个关节瘫痪，同时保留了一些“瘫痪”肌肉的自愿激活。该技术旨在逆转瘫痪关节的协同功能障碍，并通过进一步治疗恢复功能运动。一项独立的临床前试验表明，AMES治疗对创伤性脑损伤（TBI）慢性残疾患者的功能运动恢复有效。目前在美国大约有100万慢性残疾TBI患者。

DESCRIPTION (provided by applicant): The long-range goal of this project is to be able to treat effectively plegic stroke victims using a novel therapeutic regimen and robotic device called "AMES," an acronym for Assisted Movement with Enhanced Sensation. In AMES, the patient assists the motion of the robotic device using biofeedback of voluntary joint torque, while the sensation of motion is enhanced by tendon vibration. In a pre-clinical trial, we showed AMES to be effective at restoring functional movement in both upper and lower extremities in a majority of profoundly disabled chronic stroke patients (>2 yr event). At enrollment, these subjects ranked <30th percentile of normal limb strength. Despite our success at treating profoundly disabled stroke victims, AMES treatment did not restore functional movement at joints (e.g., fingers, wrist, and ankle) rendered completely plegic by the stroke. Using EMG recordings, however, we found that most plegic stroke patients retain the ability to activate voluntarily the 'plegic' muscles. Because the activity is so weak and it competes with antagonistic spasticity and co-contraction, these individuals are unable to move the joint in one or the other direction. The goal of the proposed project is to incorporate EMG biofeedback into the AMES treatment, as an alternative for torque biofeedback, in order to treat effectively profoundly plegic stroke patients. There are 2 specific aims proposed in this Phase I application. The first specific aim is to convert EMG signals into useful biofeedback on a graphics display. Two tasks must be accomplished: (1) to develop and test software to low-pass filter the EMG signals so the bandwidth (~0-2 Hz) is matched to that of the patient's efforts and (2) to present on a graphics display the activity from 2 agonist and 2 antagonist muscles in a way that it is intuitive to the patients how to correct their dyssynergia. The second specific aim is necessitated by the proposed EMG acquisition in the presence of tendon vibration-mechanical and electrical interference produced by the vibrators must be reduced in the EMG recording to levels where it does not reduce the information content of the biofeedback. Specific Aim 2 is to reduce this interference down to =2% of the overall signal amplitude. We propose to explore a number of alternative solutions to the mechanical artifact and electrical artifact problems and to implement solutions that are effective while minimizing cost. Once we have implemented useful EMG biofeedback with the AMES device, Phase II of this project will test the methodology in a controlled clinical trial. This project addresses a sub-group of chronic stroke patients with complete plegia at one or more joints, but who retain some ability to activate voluntarily the 'plegic' muscles. Our preliminary studies indicate that a sizable proportion of the 5 million chronic stroke patients in the US are plegic at one or more joints while retaining some voluntary activation of the 'plegic' muscles. The proposed technology is designed to permit the reversal of dyssynergia at plegic joints and, with further therapy, to restore functional movement. A separate pre-clinical trial indicates that AMES treatment is effective at restoring functional movement in individuals who chronically disabled by traumatic brain injury (TBI). There are current about 1 million chronically disabled TBI patients in the US.