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.

项目摘要/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(“KneBRIGHT”) 将肌电(EMG)生物反馈与视频游戏疗法(VGT)相结合的系统提供膝关节 为骨关节炎(OA)患者提供一种引人入胜的有效工具，以便在家中进行康复练习。 KneBRIGHT旨在激励骨性关节炎患者通过 引人入胜的肌电驱动的虚拟世界疗法。该系统结合了无线肌电电极， 通过提供自动指导的软件，方便患者在家庭环境中使用 循证、循序渐进的日常锻炼。重要的是，这些练习是在 形式有趣和引人入胜的活动，以促进积极的体验，并鼓励继续坚持。 有待解决的问题：在美国，骨性关节炎是导致残疾的主要原因。康复服务通过 加强股四头肌是治疗膝骨性关节炎的有效方法，但患者坚持锻炼 由于缺乏关于最佳方案的指导，以及在重复过程中缺乏参与度，例程较低 病人觉得乏味和乏味的例行公事。在无人监督的情况下，在家进行锻炼尤其具有挑战性。 需要创新的、有吸引力的解决方案来支持和促进家庭参与，特别是考虑到 由于COVID19大流行，增加了远程医疗的使用。 第二阶段成果：第二阶段工作成功开发了功能齐全的KneBRIGHT系统，并部署了 这是一项为期10周的随机对照试验，对象为膝骨性关节炎患者。使用KneBRIGHT系统的参与者 与对照组相比，锻炼组的家庭锻炼参与率增加了20%。这项研究 也表现出非常积极的可用性评级和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KneBRIGHT系统 支持膝骨性关节炎的居家理疗。新的发展将包括：游戏增强以 扩展锻炼选项和设备兼容性；升级传感器功能；安全提供商仪表板网站 用于监测和指导治疗的应用程序；与HIPAA兼容的云服务集成。追求 联邦监管机构对新设备的批准将包括安全文档、创建用户指南 和其他FDA标签，以及完成支持上市前通知的行动。建立接受度 由物理治疗从业者组成的多个膝关节骨关节炎物理治疗提供者网络将参与 一项随机对照的临床试验。创新的提供者-调查者研究模式将简化 将研究转化为临床实践。临床试验将评估KneBRIGHT系统的能力， 根据各种PTS的处方，以实现临床相关的结果。 影响：该系统将通过增加膝骨性关节炎患者对公众健康产生实质性和持续的影响 坚持在家中锻炼，从而减轻疼痛，恢复身体功能。