BandPass: A Remote Monitoring System for Sarcopenia and Functional Decline

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.