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

用于基于游戏的家庭治疗的膝关节生物反馈康复接口 (KneeBRIGHT)

• 批准号: 10603260
• 负责人: Eileen T. Krepkovich
• 金额: $ 88.53万
• 依托单位: BARRON ASSOCIATES, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10603260
• 关键词: Address; Adherence; Biofeedback; COVID-19 pandemic; Certification; Clinic; Clinical Trials; Cloud Service; Combined Modality Therapy; Computer software; Control Groups; Degenerative polyarthritis; Development; Devices; Documentation; Electrodes; Electromyography; Equilibrium; Evidence based practice; Exercise; Feedback; Health Insurance Portability and Accountability Act; Health Services Accessibility; Home; Home environment; Insurance; Knee; Knee Osteoarthritis; Label; Marketing; Measures; Modeling; Monitor; Motivation; New Device Approvals; Notification; Outcome; Pain; Participant; Patients; Performance; Phase; Physical Function; Physical therapy; Production; Protocols documentation; Provider; Psychology; Public Health; Questionnaires; Randomized; Randomized Controlled Clinical Trials; Randomized, Controlled Trials; Recovery of Function; Regimen; Rehabilitation therapy; Research Personnel; Resistance; Risk; Safety; Secure; Software Design; Specific qualifier value; Study models; Support System; System; Technology; Teletherapy; Testing; Time; Training; Translational Research; Travel; United States; Validation; Video Games; arthropathies; clinical practice; clinically relevant; comparison control; compliance behavior; control trial; cost; dashboard; design; design verification; disability; effective therapy; electromyographic biofeedback; evidence base; exercise program; exercise regimen; exercise rehabilitation; experience; functional improvement; functional outcomes; functional status; improved; innovation; next generation; pain reduction; patient engagement; programs; prototype; quadriceps muscle; remote patient monitoring; sensor; strength training; success; telehealth; tool; trend; underserved area; usability; virtual world; walking speed; web app; wireless

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.

项目概要/摘要 意义：基于游戏的家庭治疗的膝关节生物反馈康复接口（“KneeBRIGHT”） 系统将肌电图 (EMG) 生物反馈与视频游戏疗法 (VGT) 相结合，为膝关节提供治疗 为骨关节炎 (OA) 患者提供一种在家进行康复锻炼的有效工具。 KneeBRIGHT 旨在通过 引人入胜的、肌电图驱动的虚拟世界治疗该系统结合了无线肌电图电极。 方便患者在家中使用通过软件提供自动指导的软件 重要的是，这些练习是在临床实践中呈现给患者的。 形式有趣且引人入胜的活动，以促进积极的体验并鼓励持续坚持。 要解决的问题：OA 是美国康复的主要原因。 股四头肌强化是一种行之有效的治疗膝关节骨关节炎的方法，但患者必须坚持运动 由于缺乏有关最佳方案的指导以及重复过程中缺乏参与，例程率较低 患者认为乏味且无聊的日常锻炼尤其具有挑战性。 需要创新、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 由于新冠病毒大流行，远程医疗的使用有所增加。 第二阶段成果：第二阶段工作成功开发了功能齐全的 KneeBRIGHT 系统并部署 在一项为期 10 周的随机对照试验中，参与者使用 KneeBRIGHT 系统对膝关节 OA 患者进行了研究。 与对照组相比，锻炼的参与度增加了 20%。 还表现出非常积极的可用性评级以及力量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 支持膝关节骨关节炎的家庭物理治疗 新进展包括： 游戏增强功能。 扩展锻炼选项和设备兼容性；安全的提供商仪表板网络； 用于监测和指导治疗的应用程序；以及符合 HIPAA 要求的云服务集成。 新设备的联邦监管机构批准将包括安全文件、创建用户指南 和其他 FDA 标签，并完成支持上市前通知的行动以建立接受。 由物理治疗师、多个膝关节骨关节炎物理治疗提供者组成的网络将参与 一项创新的提供者作为研究者的研究模型将简化。 将研究转化为临床实践。临床试验将评估 KneeBRIGHT 系统的能力， 按照各种 PT 的规定，以达到临床相关的结果。 影响：该系统将通过增加膝骨关节炎患者的数量对公众健康产生重大和持续的影响 坚持家庭锻炼，从而减轻疼痛并恢复身体功能。