Knee osteoarthritis (KOA) is the primary cause of chronic immobility in populations over the age of 65. It is a joint degenerative disease in which the articular cartilage in the knee joint wears down over time, leading to symptoms of pain, instability, joint stiffness, and misalignment of the lower extremities. Without intervention, these symptoms gradually worsen over time, decreasing the overall knee range of motion (ROM) and ability to walk. Current clinical interventions include offloading braces, which mechanically realign the lower extremities to alleviate the pain experienced in the medial compartment of the knee joint. Though these braces have proven effective in pain management, studies have shown a significant decrease in knee ROM while using the brace. Concurrently, development of active exoskeletons for rehabilitative gait has increased within recent years in efforts to provide patients with a more effective intervention for dealing with KOA. Though some developed exoskeletons are promising in their efficacy of fostering gait therapy, these devices are heavy, tethered, difficult to control, unavailable to patients, or costly due to the number of complicated components used to manufacture the device. However, the idea that an active component can improve gait therapy for patients motivates this study. This study proposes the design of an adjustable lower extremity exoskeleton which features a single linear actuator adapted onto a commercially available offloading brace. This design hopes to provide patients with pain alleviation from the brace, while also actively driving the knee through flexion and extension. The design and execution of this exoskeleton was accomplished by 3D computer simulation, 3D CAD modeling, and rapid prototyping techniques. The exoskeleton features 3D printed, ABS plastic struts and supports to achieve successful adaptation of the linear actuator to the brace and an electromechanical system with a rechargeable operating capacity of 7 hours. Design validation was completed by running preliminary gait trials of neutral gait (without brace or exoskeleton), offloading brace, and exoskeleton to observe changes between the different gait scenarios. Results from this testing on a single subject show that there was an observed, significant decrease in average knee ROM in the offloading brace trials from the neutral trials and an observed, significant increase in average knee ROM in the exoskeleton trials when compared to the brace trials as hypothesized. Further evaluation must be completed on the clinical efficacy of this device with a larger, and clinically relevant sample size to assess knee ROM, pain while using the device, and overall comfort level. Further development of this design could focus on material assessment, cost analysis, and risk mitigation through failure mode analysis.

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