Untethered Home Therapy System

描述（由申请人提供）：目标是设计，构建和临床评估无系绳家庭治疗系统（UHTS）。所提出的系统应加快时间进程，并增加由中风引起的上肢运动缺陷的功能恢复量。目前，对脑可塑性和脑卒中后运动再学习的研究有了很大的发展和活跃。拟议的综合医疗服务将提供一个以家庭为本的持续和监测治疗系统。允许患者在家中继续治疗，灵活安排他们的时间表，应该增加治疗时间，从而改善功能。此外，它将为弱势群体提供更好的治疗机会。病人和/或他们的护理人员可以很容易地训练使用高温高温疗法。拟议的UHTS将利用可穿戴传感和刺激技术来自动调节功能性电刺激（FES）并改善治疗。UHTS将采用一种重量轻、易于穿戴的套筒，套筒内嵌干式表面肌电图（EMG）电极、运动传感器、刺激器单元和无线电收发器。无系绳设计将增加患者的安全性，并允许患者在不移除设备的情况下断开。肌电图和动力学数据将从套管传输到附近的笔记本电脑。一个动态的临床电影将指导受试者的治疗任务，包括各种简单和复杂的手臂运动，抓握力跟踪，肌电图和/或位置跟踪，抓握力任务。每项任务将在临床医生指定的特定时间段内重复进行。通过监测肌电图和动力学信号，我们将区分治疗任务，监测依从性时间，并提供反馈。此外，运动、协调模式和/或肌电图将被用作训练算法的输入，以输出适当水平的FES到目标肌肉，以辅助治疗。换句话说，当用户试图执行他们无法自愿完成的治疗任务时，它将自动检测并协助FES。一个独特的软件界面将鼓励患者通过基于电影的指导，实时反馈和医生定义的治疗目标。与功能改善相关的定量测量将计算并在报告中提交给临床医生。报告将通过互联网从患者家中传送到医生办公室，这样就可以在线监控和修改治疗。监测家庭治疗应该给医生一个改变治疗方案和确保依从性的晴雨表。具体而言，在第二阶段，我们将设计、构建和临床评估遥测套设计，升级和集成任务识别和FES算法，并升级用户界面软件。UHTS将对50名中风患者进行临床评估，以确保临床疗效。我们假设UHTS将1)准确地传输数据2)准确地检测治疗任务并在需要时应用FES， 3)提供有效的受试者反馈，4)改善运动恢复。建议的无系绳家庭治疗系统应加快时间进程，并增加由中风引起的上肢运动缺陷的功能恢复量。该系统将包括一个套筒，用户可以将其套在手臂上，该套筒将测量肌肉活动和运动，并通过视频界面提供实时反馈。该系统将提供一个以家庭为基础的持续和监测治疗的系统，并为弱势群体提供更好的治疗机会。

DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess an Untethered Home Therapy System (UHTS). The proposed system should speed the time course and increase the amount of functional recovery from upper extremity motor deficits resulting from a stroke. There currently has been tremendous growth and active research into brain plasticity and motor relearning after stroke. The proposed UHTS will provide a home-based system for continuing and monitoring therapy. Allowing patients to continue therapy at home with flexibility around their schedule should increase therapy time and hence functional improvement. Additionally, it will provide underprivileged better access for therapy. The patient and/or their caregiver could be easily trained to use the UHTS. The proposed UHTS will utilize wearable sensing and stimulating technology to automatically modulate functional electrical stimulation (FES) and improve therapy. The UHTS will employ a lightweight, easy to wear sleeve embedded with dry surface electromyography (EMG) electrodes, motion sensors, a stimulator unit, and radio transceiver. The untethered design will increase patient safety and allow patients to break without removing the device. EMG and kinetic data will be transmitted from the sleeve to a nearby laptop computer. A dynamic clinical movie will instruct subject therapy tasks, including a variety of simple and complex arm movements, grasp force tracking, EMG and/or position tracking, and grasp force tasks. Each task will be repeated for a specific clinician prescribed time period. By monitoring EMG and kinetic signals we will discriminate therapy tasks, monitor compliance time, and provide feedback. Additionally, movements, coordination patterns, and/or EMG will be used as inputs to an algorithm trained to output an appropriate level of FES to target muscles that will assist therapy. In other words, it will automatically detect when a user is trying to perform a therapy task they cannot voluntarily complete and assist with FES. A unique software interface will encourage patients through movie-based instruction, real-time feedback, and physician defined therapy goals. Quantitative measures related to functional improvement will be calculated and presented to clinicians in reports. Reports will be transmitted from patients' homes to a physician's office via the Internet so therapy can be monitored and modified on-line. Monitoring home therapy should give physicians a barometer for changing treatment protocols and ensuring compliance. Specifically during Phase II we will design, build, and clinically evaluate the telemetry sleeve design, upgrade and integrate algorithms for task discrimination and FES, and upgrade the user interface software. The UHTS will be clinically evaluated with fifty stroke subjects to ensure clinical efficacy. We hypothesize the UHTS will 1) accurately transmit data 2) accurately detect therapy tasks and apply FES when required, 3) provide effective subject feedback, and 4) improve motor recovery. The proposed untethered home therapy system should speed the time course and increase the amount of functional recovery from upper extremity motor deficits resulting from a stroke. The system will include a sleeve that the user can slip over their arm which will measure muscle activity and motion and supply real-time feedback with a video interface. The system will provide a home-based system for continuing and monitoring therapy and provide the underprivileged better access for therapy.