Project Summary / Abstract
Relatedness to Mission: Application aligns with 2019 Supplemental Goals for both NINR & 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 & 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.