# Wearable Monitoring System for Enhancing Rehabilitation Following Rotator Cuff Repair

> **NIH NIH R44** · ACTIVE4D, INC. · 2024 · $1,207,313

## Abstract

PROJECT SUMMARY
Rotator cuff tears are the most common tendon injury observed in adults. The risk for rotator cuff injury
significantly increases with age, affecting approximately 25% of the population older than 60 years and 60% of
those over the age of 80 years old. Currently, the standard of care for most rotator cuff tears is arthroscopic
surgical repair, with nearly 500,000 of these procedures performed annually in the United States and direct costs
of over $7 billion per year. Rotator cuff repair (RCR) outcomes are dependent upon successful rehabilitation,
with proper healing and functional recovery of the rotator cuff following surgical repair substantially decreasing
the high incidence of retears. Healing and recovery after RCR are dependent upon strict adherence to a delicate
rehabilitation process during which the repaired tendon must be unloaded by carefully performing controlled
movements that do not inadvertently activate contraction of the shoulder muscles. The complexity of these
movements can make it challenging for patients to maintain compliance during rehabilitation, and thus require
extensive guidance on movements during rehabilitation following RCR to reduce the risk of repair failure and
retear. There exists a clear need for the development of technologies that provide continuous, real-time guidance
to patients during rehabilitation following RCR and enable the continuous and efficient integration of valuable
patient-specific data into the design of custom rehabilitation programs. This Phase II SBIR application will build
upon promising outcomes from Active4D’s funded SBIR Phase I project which resulted in the successful design
of a wearable biofeedback system – the MyoGuard system - and demonstrated the accuracy and reproducibility
of its continuous monitoring and biofeedback of muscle activity and joint angle. The goal of the MyoGuard system
is to expedite patient return to normal activity and prevent retears following rotator cuff repair by enabling
increased patient compliance with rehabilitation exercises and improving the customization of care. This Phase
II SBIR project will focus on preparations for the commercialization of the MyoGuard system. In Aim 1, we will
optimize the design of the MyoGuard system for scalable manufacturing and increase the accessibility of the
MyoGuard phone application to better facilitate independent use of the device. In Aim 2, we will conduct human
subjects research to obtain normative activity data and evaluate human factors, including ease of use and patient
compliance. The successful completion of this SBIR Phase II project will provide strong baseline evidence to
support decision-making and the design for our future Phase I clinical trial that will test the efficacy of the
MyoGuard system in reducing complications, particularly retears, following rotator cuff repair. These key data
will ultimately allow us to seek 510K FDA regulatory approval and support rapid commercialization and
de...

## Key facts

- **NIH application ID:** 11007546
- **Project number:** 2R44AR078082-02A1
- **Recipient organization:** ACTIVE4D, INC.
- **Principal Investigator:** Geoffrey Sheean
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,207,313
- **Award type:** 2
- **Project period:** 2020-08-15 → 2026-07-01

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11007546

## Citation

> US National Institutes of Health, RePORTER application 11007546, Wearable Monitoring System for Enhancing Rehabilitation Following Rotator Cuff Repair (2R44AR078082-02A1). Retrieved via AI Analytics 2026-05-30 from https://api.ai-analytics.org/grant/nih/11007546. Licensed CC0.

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