A Patient-Driven Rehabilitation System to Improve Upper Limb Amputee Outcomes

描述（由申请人提供）：新一代灵巧假手正变得可用，其能够比传统假肢具有更多的功能。为了实现这一增强的功能，我们率先推出了一种新型控制平台，其中包括名为MyoSense的表面肌电图（EMG）模式识别算法和名为MyoLiner的首个多通道适形电极接口。这两项技术的结合使我们首次能够让截肢者除了传统的手打开和闭合功能外，还能够独立地指向食指和操作拇指。这项技术有可能在50多年来首次改变假肢控制的模式。为了最大限度地发挥影响力 和技术的准确性，康复治疗是必要的，最好是在截肢后30天的“黄金窗口”内。然而，患者适配和医疗器械报销的现实往往将假体的引入延迟到这一时期之后。基于这些考虑，我们建议将创新的MyoLiner和MyoSense技术与基于游戏的训练软件集成到一个完整的患者驱动的康复系统MyoTrain中。通过我们与南加州大学排名第一的视频游戏设计计划的合作伙伴关系，MyoTrain将专门设计用于：1）使患者能够在“黄金窗口”期间尽早地练习使用肌电控制，2）使个体能够确定他们自己的功能目标，3）提供有意义的反馈以优化患者控制他们的残肢肌肉的能力，以及4）通过令人兴奋的游戏和有意义的奖励来最大化患者的参与。在该开发结束时，我们将在8周内使用20小时后，对经桡动脉截肢者进行临床验证的上肢功能测量，以验证整个MyoTrain系统。该研究将由我们在华盛顿国家康复医院手臂截肢者项目的合作伙伴进行。在完成20小时的MyoTrain康复治疗后，截肢者将有望独立操作至少6项功能，并且在真实的时间解码准确性和上肢功能测量方面有统计学显著改善。通过这种改进的功能，我们寻求开创假肢控制的新时代，并提高灵巧假肢设备的有效功能。 公共卫生相关性：我们建议开发新的康复系统，这将有助于截肢者加强残肢肌肉和恢复上肢功能，使用灵巧肌电假肢。

DESCRIPTION (provided by applicant): A new generation of dexterous prosthetic hands is becoming available, which are capable of a greater number of functions than conventional prostheses. To enable this increased functionality, we have pioneered a novel control platform which includes a surface electromyography (EMG) pattern recognition algorithm called MyoSense and a first-of-its-kind multi-channel conformal electrode interface called MyoLiner. The combination of these two technologies has allowed us, for the first time, to give amputees the ability to point their index finger and operate their thumb independently in addition to the conventional hand open and close functionality. This technology has the potential to shift the paradigm in prosthetic control for the first time in over 50 years. In order to maximize the impact and accuracy of the technology, rehabilitation therapy is required, ideally within a 30-day "golden window" following amputation. However, the realities of patient fitting and medical device reimbursement often delay the introduction of the prosthesis well beyond this period. Based on these considerations, we propose to integrate the innovative MyoLiner and MyoSense technologies with game-based training software into a complete patient-driven rehabilitation system named MyoTrain. Through our partnership with the top ranked video game design program at the University of Southern California, MyoTrain will be specifically designed to: 1) enable patients to practice using myoelectric control as early as possible during the "golden window", 2) empower individuals to determine their own functional goals , 3) provide meaningful feedback to optimize a patient's ability to control their residual limb muscles, and 4) maximize the patient's engagement through exciting gameplay and meaningful rewards. At the conclusion of this development, we will validate the entire MyoTrain system, after 20 hours of use spread over 8 weeks, on clinically-validated upper limb functionality measures with transradial amputees. The study will be conducted by our partners at the Arm Amputee Program at the National Rehabilitation Hospital in Washington D.C. Upon completion of 20 hours of rehabilitation with the MyoTrain therapy, amputees will be expected to operate at least 6 functions independently with statistically significant improvements in real-time decoding accuracies and on the upper extremity functionality measures. With this improved functionality, we seek to usher in a new era of prosthetic control and improve the effective functionality of dexterous prosthetic devices. PUBLIC HEALTH RELEVANCE: We propose developing novel rehabilitation system that will help amputees strengthen residual limb muscles and regain upper extremity functionality using dexterous myoelectric prostheses.