BandPass: A Remote Monitoring System for Sarcopenia and Functional Decline

摘要 临床需求：随着美国人口老龄化，管理主要影响老年人的病理，包括石棺减少症 (例如，肌肉质量和力量的丧失)，这是一个重大的和日益严重的临床挑战。除了……之外 随着年龄的增长，骨质疏松症的发生率增加，人们普遍认为，急性疾病后其发病率和影响会增加， 将患者置于功能衰退、住院或死亡的额外风险中。以抵抗为基础的练习 促进肌肉再生和力量，是这类患者的推荐疗法。然而，锻炼通常是 要么在直接的临床监督下进行，要么在遵从率较低的家庭中没有患者监督。 局限性：目前的养生法依赖于自我报告日记或口头报告，这些报告可能不准确，可能会被召回 偏见。测量、跟踪、分析和提供面向患者的反馈的远程监控系统可能会克服 这些限制和提高运动养生的参与度。一种监测和传输运动的家用设备 向用户和临床医生提供的数据代表了这一临床挑战的潜在解决方案。我们的产品通行证是 支持蓝牙的遥感阻力练习带，将通过电位计准确测量力量 传感器固定在弹性管上，专为阻力训练而设计。该设备类似于目前 临床医生和患者熟悉的可用运动带，以及显著增加的集成力量 监控和互联网连接。移动应用程序和基于云的平台将为 数据可视化、存储和分析，可实现患者的直接反馈、临床监控 合规性和进步性，并作为更高级操作的平台，如自动锻炼类型 分类以减轻用户负担(例如，最大限度地减少用户与移动设备之间所需的交互)。我们 假设BandPass将提供有关运动训练依从性和使用的临床相关数据 反馈将是个性化的。具体目标：我们特别建议设计定制电子产品和 用于带通的外壳，并对器件的准确性、精密度和长期稳定性进行实验室内验证研究。 BandPass将与移动应用程序和基于云的平台对接，我们将实现数据传输， 存储和分析。最后，我们将在人类受试者的试点研究中部署带通，以演示可用性和 居家环境下的系统稳定性。未来方向：SynchroHealth是一家开发mHealth的小公司 使用联网设备帮助提高老年人生活质量的平台。这台设备将 补充我们现有的努力。在此阶段1工作结束时，我们将演示带通是 我们将提供证据，证明这种方法可以被有效地部署 在家里的环境中。这将使我们获得专注于优化我们的设备制造的第二阶段资金， 开发和优化全套基于云的分析工具和移动应用程序，进行临床试验 旨在展示有效性，并准备将其注册为510(K)豁免设备用于营销目的，以及 建立当前良好的制造规范(CGMP)。

ABSTRACT Clinical Need: As the US population ages, managing pathologies that largely affect older adults, including sarcopenia (e.g., loss of muscle mass and strength), represents a significant and growing clinical challenge. In addition to increased rates of sarcopenia with age, it is well-accepted that its incidence and impact increases after acute illness, placing persons at additional risk for functional decline, institutionalization, or death. Resistance-based exercises promote muscle regeneration and strength, and are an advised therapy for such patients. Yet, exercises are normally conducted either under direct clinical oversight, or unsupervised by patients at home, where compliance rates are low. Limitations: Current regimens rely on self-report diaries or verbal reports that may be inaccurate and subject to recall bias. Remote monitoring systems that measure, track, analyze, and provide patient-oriented feedback may overcome these limitations and enhance exercise regimen engagement. 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 is a remote-sensing, bluetooth-enabled resistance exercise band that will accurately gauge force through a potentiometric sensor rigidly fixed to elastic-tubing purposely designed for resistance training. The device is similar to currently available exercise bands familiar to clinicians and patients, with the significant novel addition of integrated force monitoring and internet-connectivity. A mobile app and cloud-based platform will provide computational resources for data visualization, storage and analysis, which will enable direct patient feedback, clinical monitoring of patient compliance and progress, and 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). We hypothesize that BandPass will provide clinically relevant data on compliance and use of exercise training with feedback that will be personalized. Specific Objectives: We specifically propose to design custom electronics and housing for BandPass and to 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 we will implement for data transmission, storage, and analysis. Finally, we will deploy BandPass in a human subjects pilot study to demonstrate usability and system stability in an at-home setting. Future Directions: SynchroHealth is a small company developing an mHealth platform that uses internet-connected devices to help improve quality of life in older adults. This device will complement our existing efforts. By the end of this Phase 1 effort, we will have demonstrated that BandPass is functional in a human population and we will have provided evidence that this approach can be deployed effectively in an at-home setting. This will position us for Phase 2 funding focused on optimizing our device for manufacturing, developing and optimizing a full suite of cloud-based analysis tools and mobile applications, conducting clinical trials aimed at demonstrating efficacy, and preparing to register this as a 510(k)-exempt device for marketing purposes and establishing Current Good Manufacturing Practices (CGMP).