Toward Personalized Orthopedic Care: Validation of a Smart Knee Brace

Abstract Introduction Wearable technology offers a promising solution to advance current rehabilitation strategies for post-operative orthopedic care. The aim of this study was to determine the level of agreement and concurrent validity of a smart knee brace compared to the gold standard measurement system GAITRite® for assessing lower limb gait parameters. Methods Thirty-four healthy participants were fitted with the smart knee brace (Digital Knee®) on their dominant limb. Gait parameters (stride length, stride time, and gait velocity) were measured simultaneously using the Digital Knee® and the GAITRite® electronic walkway. Two walks were performed at a comfortable speed and two at a fast-walking speed. Results At a comfortable walking speed, stride time was moderately valid (ICC2,1 = 0.66 s), and stride length and gait velocity demonstrated poor validity (ICC2,1 = 0.29; ICC2,1 = 0.41). All gait parameters demonstrated poor validity at a fast-walking speed (ICC2,1 = −0.16 to −0.01). Bias ranged from −0.08 to 0.28, with more clinically acceptable percentage errors at a comfortable walking speed (14.1–30%) versus at a fast-walking speed (26.4–42.6%). Gait velocity and stride length had substantially higher biases in the fast-walking speed compared to the comfortable walking speed (0.28 ± 0.39 m s−1 vs. 0.02 ± 0.21 m s−1; 0.15 ± 0.23 m vs. −0.04 ± 0.17 m). Limits of agreement were considered narrower for stride time compared to stride length and gait velocity. Conclusion The Digital Knee® is a promising approach to improving post-operative rehabilitation outcomes in patients with osteoarthritis. The Digital Knee® demonstrated good agreement and moderate concurrent validity for measuring gait metrics at a comfortable walking speed. These findings highlight the opportunity of the wearable sensor as an intervention for post-operative orthopedic care. This was a laboratory-based study; thus, further research is required to validate the wearable sensor in real-world contexts and in patients with knee pathologies. Further, refinement of the algorithm for measuring gait metrics at slow- and fast-walking speed with the Digital Knee® is warranted.