The Reliability and Validity of an Instrumented Device for Tracking the Shoulder Range of Motion.

Rotator cuff tears are common in individuals over 40, and physical therapy is often prescribed post-surgery. However, access can be limited by cost, convenience, and insurance coverage. CuffLink is a telehealth rehabilitation system that integrates the Strengthening and Stabilization System mechanical exerciser with the interACTION mobile health platform. The system includes a triple-axis accelerometer (LSM6DSOX + LIS3MDL FeatherWing), a rotary encoder, a VL530X time-of-flight sensor, and two wearable BioMech Health IMUs to capture upper-limb motion. CuffLink is designed to facilitate controlled, home-based exercise while enabling clinicians to remotely monitor joint function. Concurrent validity and test-retest reliability were used to assess device accuracy and repeatability. The results showed moderate to good validity for shoulder rotation (ICC = 0.81), device rotation (ICC = 0.94), and linear tracking (from zero: ICC = 0.75 and RMSE = 2.41; from start: ICC = 0.88 and RMSE = 2.02) and good reliability (e.g., RMSEs as low as 1.66 cm), with greater consistency in linear tracking compared to angular measures. Shoulder rotation and abduction exhibited higher variability in both validity and reliability measures. Future improvements will focus on manufacturability, signal stability, and force sensing. CuffLink supports accessible, data-driven rehabilitation and holds promise for advancing digital health in orthopedic recovery.