Untethered Home Therapy System

描述(由申请者提供)：目标是设计、建造和临床评估自由系留家庭治疗系统(UHTS)。建议的系统应该加快时间进程，并增加中风导致的上肢运动障碍的功能恢复量。目前，对于中风后的大脑可塑性和运动再学习，已经有了巨大的发展和活跃的研究。拟议的uHTS将提供一个以家庭为基础的系统，用于继续和监测治疗。允许患者在家中继续治疗，并灵活安排他们的时间表，应该会增加治疗时间，从而改善功能。此外，它还将为弱势群体提供更好的治疗机会。患者和/或他们的照顾者可以很容易地接受使用UHTS的培训。拟议的uHTS将利用可穿戴式传感和刺激技术来自动调节功能性电刺激(FES)，并改进治疗。UHTS将采用一种重量轻、易于穿戴的套筒，内嵌干表面肌电(EMG)电极、运动传感器、刺激单元和无线电收发机。无绳索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。肌电和运动数据将从套筒传输到附近的笔记本电脑。一部充满活力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动作，抓握力跟踪、肌电和/或位置跟踪，以及抓握力任务。每项任务将在特定的临床医生规定的时间段内重复进行。通过监测肌电和运动信号，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/或肌电将被用作算法的输入，该算法被训练为向目标肌肉输出适当水平的FES，以帮助治疗。换句话说，它将自动检测用户何时试图执行他们无法自愿完成的治疗任务，并协助FES。独特的软件界面将通过基于电影的指导、实时反馈和医生定义的治疗目标来鼓励患者。与功能改善相关的量化指标将被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输到医生的办公室，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提供一个改变治疗方案和确保依从性的晴雨表。具体地说，在第二阶段，我们将设计、建造和临床评估遥测套筒设计，升级和集成任务识别和FES算法，并升级用户界面软件。UHTS将在50名中风患者中进行临床评估，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。拟议的自由家庭治疗系统应该会加快时间进程，并增加中风导致的上肢运动障碍的功能恢复量。该系统将包括一个袖子，用户可以滑到他们的手臂上，它将测量肌肉活动和运动，并通过视频界面提供实时反馈。该系统将为持续和监测治疗提供一个以家庭为基础的系统，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.