PROJECT SUMMARY More than 795,000 individuals suffer from a stroke each year in the United States, making stroke a leading cause of adult disability in the United States and worldwide. More than half of stroke survivors exhibit reduced independence and functional mobility due to stroke-related gait impairments. Despite significant advancements in post-stroke medical care and rehabilitation, current treatments are not successful in optimally restoring gait function after stroke. It is well established that intense, repetitive task-oriented rehabilitation interventions are essential for inducing experience-dependent neuroplasticity (defined as the ability of the nervous system to adapt and optimize its resources through structural and functional changes)—which is a key factor for post-stroke gait recovery. Accordingly, new therapeutic approaches that rely on specialized gait training devices, such as treadmills, robotic devices, and exosuits have been developed. However, these devices are typically expensive, bulky, and not accessible for home use. Moreover, these devices often require uninterrupted power sources, which is a major barrier for rural communities in developing nations. While some lightweight and “low-cost” commercial devices exist, they are not often designed based on multi-user feedback and robust biomechanical data and their clinical utility have not been tested in stroke survivors, thereby limiting usability and effectiveness. Thus, there is a significant unmet clinical need for an effective, affordable, and portable gait mobility/rehabilitation device that is accessible for most stroke survivors. Elite Athlete Products (EAP) has designed a wearable gait rehabilitation system, NewGait, that specifically addresses this clinical need. In this Phase-I STTR, EAP has assembled an interdisciplinary team to pursue the following specific aims: (1) Identify an optimal NewGait design based on end-user feedback (design sprints) and musculoskeletal modeling to address the needs of stroke rehabilitation, (2) Refine the current prototype using data gathered from design sprints and think aloud technique and perform benchtop testing on the final prototype to validate durability, and (3) Examine short-term gait adaptations and clinical feasibility in stroke survivors by performing a comparative clinical feasibility study in stroke survivors to establish the clinical utility of the NewGait device in comparison with two competitive devices (TheraSuit and TheraTogs). This project combines EAP’s expertise in developing low-cost neurorehabilitation devices with the clinical, biomechanical, and neuroplasticity expertise of our academic partners at the University of Michigan and Wayne State University. The successful completion of this Phase-I STTR will lay the foundation for an evidence-based low-cost gait rehabilitation system that could positively affect the lives of millions of stroke survivors living across the globe.

PROJECT NARRATIVE Despite significant advancements in post-stroke medical treatments and rehabilitation interventions, more than half of stroke survivors cannot walk independently in the community. Current rehabilitation devices aimed at restoring walking function are either large and unaffordable or ineffective in improving walking function, creating a significant unmet need for a portable, affordable, and effective gait mobility/rehabilitation device. In this Phase- I STTR, Elite Athlete Products will incorporate stroke-specific modifications to the current NewGait device based on end-users’ feedback and biomechanical simulations and rigorously test this device against competitors’ products to make evidence-based gait training strategies accessible to all stroke survivors.