BandPass: A Remote Monitoring System for Sarcopenia and Functional Decline

BandPass：肌肉减少症和功能衰退的远程监测系统

• 批准号: 10697080
• 负责人: Ryan Joseph Halter
• 金额: $ 91.92万
• 依托单位: SYNCHROHEALTH LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10697080
• 关键词: Accelerometer; Acute; Address; Adherence; Affect; Age; Algorithms; American; Bluetooth; Businesses; Calibration; Caring; Cessation of life; Classification; Clinical; Cognitive; Computer software; Consumption; Custom; Data; Data Collection; Data Science; Device Designs; Devices; Diagnosis; Distal; Drops; Elasticity; Elderly; Electronics; Exercise; Feedback; Future; Goals; Hand Strength; Health; Healthcare; Home; Hour; Housing; Infrastructure; Institutionalization; Internet; Interview; Lead; Marketing; Measurement; Measures; Medical Device; Methods; Monitor; Morbidity - disease rate; Motion; Muscular Atrophy; Musculoskeletal; Non-Invasive Detection; Outcome; Pain; Patient Monitoring; Patient Monitoring System; Patient Self-Report; Patients; Persons; Phase; Physical Function; Physical Performance; Physicians; Pilot Projects; Positioning Attribute; Predictive Analytics; Procedures; Production; Quality of life; Recommendation; Recovery; Recovery of Function; Recreation; Reporting; Research Design; Resistance; Resolution; Resources; Risk; Self-Help Devices; Services; Site; Small Business Technology Transfer Research; Sports; Structure; Surveys; System; Technology; Testing; Time; Training; Tube; Variant; Vision; Visual; Writing; age group; aging in place; classification algorithm; clinically relevant; cloud based; commercialization; compliance behavior; computing resources; cost; dashboard; data communication; data exchange; data visualization; design; diaries; disability; disability risk; evidence base; exercise adherence; exercise physiologist; exercise program; exercise training; experience; frailty; functional decline; handheld mobile device; improved; innovation; mHealth; machine learning algorithm; manufacture; mobile application; monitoring device; muscle form; muscle hypertrophy; muscle regeneration; muscle strength; novel; operation; patient oriented; physical therapist; preservation; remote monitoring; remote patient monitoring; remote sensing; resistance exercise; sarcopenia; satisfaction; sensor; standard care; success; transmission process; usability; user centered design; user-friendly; validation studies; verbal

PROJECT SUMMARY Clinical Need: Sarcopenia and frailty represent significant and growing clinical challenges whose rates increase with age, and place patients at risk for functional decline, institutionalization, or death. Resistance exercises are strongly recommended in this age group to promote muscle regeneration and strength and are routinely a part of evidence-based home exercise programs prescribed by physical therapists. If conducted as advised, patients can recover from acute illness, preserve their independence, and reduce their risk of morbidity. Current Clinical Challenge: A major gap in home exercise programs is a clinician's reliance on self-report diaries or verbal reports that may be inaccurate or may be subject to recall bias. Remote patient monitoring systems that measure, track, analyze, and provide patient-oriented feedback may overcome these limitations and have the potential to enhance exercise adherence. An at-home device that monitors and transmits exercise data to the user and clinician represents a potential solution to this clinical challenge. Our product – BandPass – SynchroHealth is a small business entity that developed a remote monitoring solution to fulfil this market need. BandPass consists of a remote-sensing, Bluetooth-enabled, resistance exercise band that will accurately gauge force through potentiometric and multi-axial sensors, rigidly fixed to elastic-tubing purposely designed for resistance exercise training. The device is visually similar to currently available exercise bands familiar to clinicians and patients. However, the device has a significantly novel addition of integrating force monitoring while connecting to the cloud through a patient app. A mobile app and a clinician cloud-based platform will provide computational resources for data visualization, storage, and analysis. This will enable direct patient feedback, clinical monitoring of patient compliance and progress, and will serve as a platform for more advanced operations such as automatic exercise-type classification to ease user burden (e.g., minimizing required interactions between the user and mobile device). Specific Objectives: We propose to commercialize the custom design electronics and housing for BandPass and perform in-lab validation studies of device accuracy, precision, and long-term stability. BandPass will be interfaced to a mobile app and cloud-based platform for its data transmission, storage, and analysis. We will collect data on correct and incorrect usage of BandPass to drive classification algorithms that will facilitate automatic guidance to patients in completing effective exercise programs. Then, we will conduct a user-centered design study to examine how to communicate data to patients and clinicians. Finally, we will deploy BandPass in a pilot study to show initial efficacy at home. Future Directions: SynchroHealth's vision is to develop a mobile health, user-friendly platform using internet-connected devices to improve the quality of life and physical function of older adults. At the end of Phase II, we will have demonstrated BandPass' functionality by providing evidence that it can be deployed at home. This will position us for commercial success by preparing this Class II exempt medical device for marketing, production, and execution of commercial engagements.

项目摘要 临床需求：肌肉减少症和虚弱代表了显著且不断增长的临床挑战，其发生率增加 随着年龄的增长，并将患者置于功能衰退、机构化或死亡的风险中。抵抗运动是 强烈建议在这个年龄组，以促进肌肉再生和力量，并定期一部分 基于证据的家庭锻炼计划由物理治疗师规定。如果按照建议进行，患者 可以从急性疾病中恢复，保持他们的独立性，并降低他们的发病风险。当前临床 挑战：家庭锻炼计划的一个主要差距是临床医生对自我报告日记或口头报告的依赖 这可能是不准确的，或者可能会受到回忆偏见的影响。远程病人监护系统，测量，跟踪， 分析和提供以患者为导向的反馈可以克服这些限制，并有可能 增强锻炼坚持性。一种家用设备，其监测并向用户传输锻炼数据， 临床医生代表了这种临床挑战的潜在解决方案。我们的产品- BandPass - SynchroHealth 一家小型企业实体开发了远程监控解决方案来满足这一市场需求。BandPass包括 一个遥感，蓝牙功能，阻力锻炼带，将准确地衡量力量， 电位计和多轴传感器，刚性固定在专为阻力锻炼设计的弹性管上 训练该器械在视觉上类似于临床医生和患者熟悉的现有运动带。 然而，该设备具有显著新颖的附加功能，即在连接到 移动的应用程序和临床医生基于云的平台将提供计算 用于数据可视化、存储和分析的资源。这将实现直接的患者反馈、临床监测 患者的依从性和进展，并将作为更先进的操作，如自动 减轻用户负担的锻炼类型分类（例如，最小化用户之间所需的交互， 移动终端）。具体目标：我们建议将定制设计的电子产品和外壳商业化 并对设备准确度、精密度和长期稳定性进行实验室验证研究。 BandPass将连接到一个移动的应用程序和基于云的平台，用于数据传输、存储和 分析.我们将收集关于BandPass正确和不正确使用的数据，以驱动分类算法， 将有助于自动指导患者完成有效的锻炼计划。然后，我们将进行一次 以用户为中心的设计研究，以检查如何将数据传达给患者和临床医生。最后我们将 在试点研究中部署BandPass，以显示在家中的初步疗效。未来方向：SynchroHealth的愿景是 开发一个使用互联网连接设备的移动的健康、用户友好的平台，以改善生活质量 和老年人的身体功能。在第二阶段结束时，我们将展示BandPass的功能 通过提供证据证明它可以在家里部署。这将使我们能够通过准备 该II类豁免医疗器械用于营销、生产和执行商业活动。