BandPass: A Remote Monitoring System for Sarcopenia and Functional Decline

项目总结 临床需求：骨质疏松症和虚弱是严重且日益严重的临床挑战，其发生率会增加。 随着年龄的增长，并使患者面临功能衰退、住院或死亡的风险。抵抗力练习 强烈建议这个年龄段的人促进肌肉再生和力量，并经常成为 理疗师开出的循证家庭锻炼计划。如果按建议进行，患者 可以从急性疾病中恢复，保持他们的独立性，并降低他们发病的风险。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差的影响。远程患者监控系统，测量、跟踪、 分析并提供面向患者的反馈可能会克服这些限制，并有可能 提高锻炼的坚持性。监视运动数据并将其发送给用户的家用设备，以及 临床医生代表了这一临床挑战的潜在解决方案。我们的产品-带通-同步健康是 开发远程监控解决方案以满足这一市场需求的小型企业实体。带通由以下部分组成 一种支持蓝牙的遥感阻力练习带，它将通过 电位计和多轴传感器，固定在专门为阻力训练而设计的弹性管上 训练。该设备在视觉上类似于临床医生和患者熟悉的当前可用的运动带。 然而，该设备增加了一个非常新颖的功能，即在连接到 通过患者应用程序进行云操作。移动应用程序和基于云的临床医生平台将提供计算 用于数据可视化、存储和分析的资源。这将使患者能够直接反馈、临床监控 患者依从性和进展，并将作为更高级操作的平台，如自动 练习类型分类以减轻用户负担(例如，最大限度地减少用户和 移动设备)。具体目标：我们建议将定制设计的电子产品和住房商业化 用于带通并执行设备准确性、精确度和长期稳定性的实验室验证研究。 BandPass将与移动应用和基于云的平台对接，用于其数据传输、存储和 分析。我们将收集有关正确和不正确使用带通的数据，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，研究如何将数据传达给患者和临床医生。最后，我们会 在一项试点研究中部署带通，以显示在家中的初步效果。未来方向：SynchroHealth的愿景是 开发一个移动健康、用户友好的平台，使用连接互联网的设备来提高生活质量 以及老年人的身体机能。在第二阶段结束时，我们将演示带通的功能 通过提供证据证明它可以在家里部署。这将为我们的商业成功做好准备 此II类豁免医疗器械用于商业活动的营销、生产和执行。

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.