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：肌肉减少症和脆弱的临床挑战，其比率增加 随着年龄的增长，并使患者处于功能下降，制度化或死亡的风险。抵抗运动是 强烈建议在这个年龄组中促进肌肉再生和力量，并且通常是 物理治疗师规定的循证家庭锻炼计划。如果按照建议进行，患者 可以从急性疾病中康复，保持独立性并降低发病率的风险。当前的临床 挑战：家庭锻炼计划的主要差距是临床对自我报告日记或口头报告的依赖 这可能是不准确的，或者可能会召回偏见。远程患者监视系统，以测量，跟踪， 分析并提供面向患者的反馈可能会克服这些局限性，并有可能 增强运动依从性。一个家庭设备，可监视和将锻炼数据传输给用户和 临床医生代表了解决这一临床挑战的潜在解决方案。我们的产品 - BandPass - SynchroHealth是 一个开发远程监控解决方案以满足市场需求的小型企业实体。带通构成 一个遥感，具有蓝牙的电阻运动带的 电位计量和多轴传感器，牢固地固定在弹性管上，故意设计用于电阻运动 训练。该设备在视觉上与临床医生和患者熟悉的当前可用运动带相似。 但是，该设备在连接到该设备时具有大量新颖的添加。 通过患者应用程序云。移动应用程序和基于云云的平台将提供计算 用于数据可视化，存储和分析的资源。这将使直接患者反馈，临床监测 患者合规性和进度的依据，并将作为更高级操作（例如自动操作）的平台 锻炼类型的分类以简化用户伯恩（例如，最大程度地减少用户与用户之间的互动 移动设备）。特定目标：我们建议商业化定制设计电子和住房 用于带通和执行LAB验证研究的设备准确性，精度和长期稳定性。 BandPass将干扰其数据传输，存储和基于云的平台和基于云的平台 分析。我们将收集有关带通的正确和错误用法的数据，以驱动分类算法 将促进为患者完成有效锻炼计划的自动指导。然后，我们将进行 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，我们会的 在一项试点研究中部署带通，以显示在家中的初始效率。未来的方向：SynchroHealth的愿景是 使用与互联网连接的设备开发移动健康，用户友好的平台，以提高生活质量 和老年人的身体机能。在第二阶段结束时，我们将演示带通的功能 通过提供可以在家中部署的证据。这将使我们通过准备商业成功 该II类免除营销，生产和执行商业参与的医疗设备。