Conclusions
voice, arm flexion and extension, UE neuromuscular impairment, orthosis, UE impairment
Loss of independence due to UE neuromuscular impairment represents a high socio-economic burden for society. Current rehabilitation methods and commercially available UE active orthoses seem limited in their capability to restore function and thus improve independence in individuals living with UE impairment. The NuroSleeve has been designed, developed, and clinically evaluated to address these limitations.The NuroSleeve is an innovative user-centric 3D-printed UE active orthosis and FES system that improves function and independence in ADLs for individuals with UE neuromuscular impairment. To overcome the limitations of existing neurotechnology, the NuroSleeve deploys 3D scanning, 3D printing and introduces a design that is user-centered, lightweight, easy to don and doff, and user-friendly. Furthermore, the NuroSleeve provides innovative options for control methods (inputs) and effectors (outputs) that can be customized and used in various combinations resulting in a functionally and clinically effective active orthosis for both home and clinical use. Current control methods include manual, EMG, IMU, and voice controls, while the effectors include a linear actuator that opens and closes the hand and two channels of FES. The team will continue its research and development activities to improve upon the device’s design and functionality; for example, work is underway to incorporate an elbow brace into the NuroSleeve, which will provide the user with more degrees of freedom (DOF), particularly arm flexion and extension. We also aim to integrate wireless sensors and improve the battery life so the user may operate it for longer without needing to recharge.The NuroSleeve was pre-clinically evaluated using state-of-the-art bench testing to ensure adequate performance, safety, and quality metrics. Bench test results demonstrate that the NuroSleeve meets all of its technical objectives and operational requirements due to its customizable and flexible hardware and firmware designs. Preliminary findings of the clinical trial reveal that NuroSleeve meets its clinical objectives and addresses previously unmet clinical needs. The NuroSleeve has shown to be beneficial to the individuals who have enrolled in the ongoing trial; however, it can only become beneficial and available to the large population of individuals living with UE impairment if it becomes a commercially available FDA-cleared medical device. To achieve this goal, a product development plan is in place, which includes an FDA-compliant Quality Management System, a redesign and optimization, further bench testing to meet all FDA requirements, and a subsequent pivotal clinical trial. Such steps will ensure that future iterations of the NuroSleeve may be available to more individuals with UE impairment and potentially become part of clinical care.