Results Group, LLC SBIR Phase II Award, May 2021

Project Summary / Abstract Relatedness to Mission: Application aligns with 2019 Supplemental Goals for both NINR andamp; NIA.: NINR: Assistive…devices that can… improve quality of life for individuals with chronic diseases/conditions NIA: Development of technologies/robotics to assist in the improvement of physical function and mobility in older persons prior to (pre-habilitation) or following (rehabilitation) elective/planned surgery Medical need: This application focuses on secondary prevention of diabetic foot ulcer (DFU) when patients are most vulnerable. DFU is the leading cause of amputation, more costly than the most expensive cancer, and survivors of lower limb amputation have a higher mortality rate than half of the top 10 cancers. Invention: Together with patient input, team has designed a novel assistive exoskeleton that has been shown in Ph I studies to off-load pressure from the foot by deploying a disruptive design for rehabilitation robotics. It integrates a structural exo-skeleton to externalize lower limb forces outside of the body. In two Phase I studies, the exoskeleton has demonstrated reduction of force under the forefoot. Unexpectedly, the device has also demonstrated improved propulsion by increasing stride length and walking speed concurrent to reducing plantar pressures. The device has received enthusiastic patient feedback from multiple participants who enjoyed feeling a “spring in their step” and showed no negative impact on measures of fall risk. Aim 1) Product Refinement Engineering: Team will improve upon Ph I prototypes to overcome issues with comfort and to ensure durability and robustness. Aim 2) Motor Restoration of Gait andamp; Balance, Activity, Psycho-Social: The prototypes will be evaluated for their ability to help restore clinical gait function and balance at 1, 3 and 6 months after completion of wound healing subsequent to DFU treatment as well as their impact on the restoration of daily physical activity level and psycho social measures. Efficacy (recurrence rates) are beyond the available budget of SBIR and will be pursued with collaborative university led research. Rationale: The team recently completed two Phase I SBIR funded studies through NIH/National Institute of Nursing Research and ACL/National Institute for Disability, Independent Living and Rehabilitation Research. Results show that the prototypes were able to off-load significant pressure by externalizing forces. Team has been awarded 4 issued US patents and international IP. If successful, this will be the first disruptive innovation in off-loading in decades and illuminates key design factors for future evaluation of robotic off- loading devices and sensor controlled devices.Project Narrative Diabetic Foot Ulcer (DFU) is the leading cause of foot and leg amputation, its prevalence is increasing dramatically and it is a more expensive burden to the US healthcare system than lung cancer, those with foot amputation have a higher mortality rate than half of the top 10 cancers. The major problem with DFU is frequency of recurrence – with the majority of people experiencing DFU recurrence within the first two years, and the majority of those occurring within the first 180 days after treatment. The proposed solution introduces a novel exoskeleton that uses springs instead of a motor and which has been shown in Phase I testing to off- load clinically significant pressure in areas at highest risk for ulceration, while also improving walking speed and stride length, thereby providing a new and disruptive option for the prevention of diabetic foot ulcer recurrence / amputation and risk of mortality.