Electronics-Free Soft Robotic Knee Brace for Dynamic Unloading During Gait for Knee Osteoarthritis: A Proof-of-Concept Study

We present a novel electronics-free soft robotic knee brace which employs a closed-loop fluidic regenerative (CLFR) system for dynamic unloading in unicompartmental tibiofemoral osteoarthritis (OA). The existing dynamic unloaders are bulky, large, and heavy, and have low compliance likely due to the use of an electrical control box, which is eliminated in the CLFR system. The system consists of a commercial unloading knee brace, a spring-loaded bellow inserted under the heel inside a shoe, a soft-fluidic actuator (bladder), and tubing for fluid transfer. The novelty lies in the fact that the user's body weight (self-powered) compresses the bellow to provide energy to inflate the air bladder placed at the knee. As a result, the yielded pressure unloads the undesirable forces due to knee OA during the stance phase of gait while strategically applying no forces during the swing phase. The knee bladder contact pressure/force, the system response time, and the durability were evaluated via contact pressure measurements for six systems with varying bellow volumes and either pneumatic or hydraulic configurations. All systems produced safe pressure outputs for human skin within a tested bodyweight range of 60-90 kg. Pneumatic and hydraulic systems achieved 250 ms and 400 ms pressurization response times, respectively. During cyclic loading, pneumatic and hydraulic systems demonstrated less than 1% and similar to 10% pressure loss, respectively. Overall, the CLFR system created a promising electronics-free solution for dynamically unloading the knee during gait, indicating a potential new paradigm for knee braces.