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，包括肌肉减少症 (e.g.,肌肉质量和力量的损失），代表了一个重要的和不断增长的临床挑战。除了 随着年龄的增长，肌肉减少症的发生率增加，普遍认为其发病率和影响在急性疾病后增加， 使人们面临功能衰退、机构化或死亡的额外风险。基于阻力的练习 促进肌肉再生和力量，是这类患者的建议疗法。然而，演习通常是 要么在直接临床监督下进行，要么在家中不受患者监督，依从率很低。 局限性：目前的治疗方案依赖于自我报告日记或口头报告，这些报告可能不准确，并且可能会被召回 bias.测量、跟踪、分析和提供面向患者的反馈的远程监测系统可以克服 这些限制和增强锻炼方案的参与。一种监控和传输运动的家用设备 向用户和临床医生提供数据代表了对该临床挑战的潜在解决方案。我们的产品- BandPass 一个遥感，蓝牙功能的阻力运动带，将准确地衡量力通过电位计 传感器刚性固定到弹性管专门设计的阻力训练。该设备类似于目前 临床医生和患者熟悉的可用运动带，具有显著的新的集成力 监控和互联网连接。一个移动的应用程序和基于云的平台将提供计算资源， 数据可视化，存储和分析，这将使直接的病人反馈，病人的临床监测 合规性和进步，并作为一个平台，更先进的业务，如自动演习型 分类以减轻用户负担（例如，最小化用户和移动终端之间所需的交互）。我们 假设BandPass将提供关于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， 用于BandPass的外壳，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，我们将实施数据传输， 存储和分析。最后，我们将在人体试验研究中部署BandPass，以证明其可用性和 系统在家中的稳定性。未来发展方向：SynchroHealth是一家小公司， 该平台使用互联网连接的设备来帮助改善老年人的生活质量。这款设备将 补充我们现有的努力。在第一阶段工作结束时，我们将证明BandPass是 在人群中发挥作用，我们将提供证据证明这种方法可以有效地部署 在一个家庭环境中。这将使我们能够获得第二阶段的资金，重点是优化我们的制造设备， 开发和优化全套基于云的分析工具和移动的应用程序，进行临床试验 旨在证明有效性，并准备将其注册为510（k）豁免器械用于上市， 现行良好生产规范（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).