Knee-Biofeedback Rehabilitation Interface for Game-based Home Therapy (KneeBRIGHT)

项目总结/摘要 意义：用于游戏式家庭治疗的膝关节生物反馈康复界面（“KneeBRIGHT”） 该系统结合了肌电图（EMG）生物反馈和视频游戏治疗（VGT）， 为骨关节炎（OA）患者提供一种在家中进行康复锻炼的有效工具。 KneeBRIGHT旨在鼓励OA患者定期进行肌肉强化运动， 吸引人的，肌电驱动的虚拟世界疗法该系统结合了无线EMG电极， 方便患者在家庭环境中使用软件， 循证的渐进式锻炼计划重要的是，这些练习是在 一种有趣和吸引人的活动形式，以促进积极的体验并鼓励继续坚持。 要解决的问题：OA是美国残疾的主要原因。教养 股四头肌强化是一种公认的有效治疗膝关节OA的方法，但患者坚持锻炼 由于缺乏关于最佳方案的指导，以及在重复性检查期间缺乏参与， 病人们觉得乏味无聊的例行程序无人监督的在家锻炼尤其具有挑战性。 需要创新的、有吸引力的解决方案来实现和促进家庭参与，特别是考虑到 由于COVID 19大流行，增加了远程医疗的使用。 第二阶段成果：第二阶段工作成功地开发了一个功能齐全的KneeBright系统，并部署在 在一项为期10周的随机对照试验中，对膝关节OA患者进行了研究。使用KneeBright系统的参与者 与对照组相比，参加家庭锻炼的人数增加了20%。研究 还显示出非常积极的可用性评级以及强度和平衡结果的积极趋势。 IIB阶段计划摘要：拟议的IIB阶段工作将产生商业KneeBright系统 支持膝关节OA的家庭物理治疗。新的发展将包括：游戏增强， 扩展锻炼选项和设备兼容性;升级的传感器功能;安全的提供商仪表板Web 用于监测和指导治疗的应用程序;以及符合HIPAA的云服务集成。追求 新设备的联邦监管批准将包括安全性文件，用户指南的创建 和其他FDA标签，并完成支持上市前通知的行动。建立接受 物理治疗从业者，多个膝关节OA物理治疗提供者的网络将参与， 一项随机对照临床试验一个创新的提供者作为研究者的研究模式将简化 将研究成果转化为临床实践。临床试验将评估KneeBright系统的能力， 按照各种PT的规定，以实现临床相关结局。 影响：该系统将通过增加膝关节OA患者，对公共卫生产生实质性和持续的影响。 坚持家庭锻炼，从而减少疼痛和恢复身体功能。

PROJECT SUMMARY/ABSTRACT Significance: The Knee Biofeedback Rehabilitation Interface for Game-based Home Therapy (“KneeBRIGHT”) system combines electromyography (EMG) biofeedback with video game therapy (VGT) to provide knee osteoarthritis (OA) patients with an engaging, effective tool for conducting rehabilitation exercises at home. KneeBRIGHT aims to motivate OA patients to conduct regular muscle strengthening exercise through an engaging, EMG-driven virtual worlds therapy. The system combines wireless EMG electrodes that are convenient for patients to use in a home setting with software that provides automated guidance through evidence-based, progressive exercise routines. Importantly, these exercises are presented to the patient in the form of fun and engaging activities to promote a positive experience and encourage continued adherence. Problem to be Addressed: OA is the leading cause of disability in the United States. Rehabilitation through quadriceps strengthening is a well-established, effective treatment for knee OA but patient adherence to exercise routines is low due to lack of guidance regarding optimal protocols and lack of engagement during the repetitive routines that patients find tedious and boring. Unsupervised, home-based exercise is particularly challenging. Innovative, engaging solutions are needed to enable and facilitate home participation, especially given the increased the use of telehealth due to the COVID19 pandemic. Phase II Results: The Phase II effort successfully developed a full-featured KneeBRIGHT system and deployed it in a 10-week randomized, controlled trial with knee OA patients. Participants using the KneeBRIGHT system for exercise increased their home exercise session participation by 20% compared to the control group. The study also demonstrated very positive usability ratings and positive trends in strength and balance outcomes. Phase IIB Program Summary: The proposed Phase IIB effort will yield a commercial KneeBRIGHT system supporting home-based physical therapy for knee OA. New developments will include: game enhancements to expand exercise options and device compatibility; upgraded sensor features; a secure provider dashboard web application for monitoring and guiding therapy; and HIPAA compliant cloud services integration. Pursuit of federal regulatory approval for the new device will include documentation of safety, creation of a user’s guide and other FDA labeling, and completion of actions supporting premarket notification. To establish acceptance by physical therapy practitioners, a network of multiple knee OA physical therapy providers will participate in a randomized, controlled clinical trial. An innovative provider-as-investigator study model will streamline translation of research to clinical practice. The clinical trial will evaluate the ability of the KneeBRIGHT system, as prescribed by a variety of PTs, to achieve clinically relevant outcomes. Impact: The system will have a substantial and sustained impact on public health by increasing knee OA patient adherence to home exercise and thereby reducing pain and restoring physical function.