Sunday, December 22, 2024
12/22/2024
Project Summary / Abstract Relatedness to Mission: Application aligns with multiple 2016 NINR SBIR goals - · G. Technologies to treat chronic wounds that fail to heal, specifically… diabetic ulcers. · B. Devices that improve the acceptance and use of assistive devices. · B. Devices that improve delivery of care to persons who have restricted movement due to… peripheral vascular disease…. to allow them to better self-manage. · D. Technologies to assist in health promotion and prevention Medical need: This application is towards rehabilitation & secondary prevention of Diabetic Foot Ulcer (DFU). DFU is more costly than the most expensive cancer; it is the leading cause of lower limb amputations ; and survivors of lower limb amputation have a higher mortality rate than half of the top 10 cancers. Invention: The device is focused on secondary prevention of DFU by reducing pressure on the areas of the foot at greatest risk for ulceration. With patient input, team has designed a novel assistive device that off-loads pressure from the foot by deploying a disruptive design for rehabilitation robotics. It integrates structural exo- skeletons and exo-tendons to externalize lower limb forces outside of the body. PI holds US patents on the exo- skeletons deployed as a low-cost easily manufactured non-powered device and a motorized robotic version. In a peer reviewed publication of team’s initial proof-of-concept testing, the device demonstrated clinically significant off-loading of greater than 22%, which is similar to the off-loading achieved through surgical intervention. The device also received positive patient feedback regarding gait stability. Aim 1) Prototype refinement and instrumentation: Initial proof of concept demonstrated ability to re-route force outside a patient’s body. Now, team must create instrumented prototypes with specific ability to precisely adjust the “dose” level of spring force and the bio-mechanical geometry at which these forces engage. Aim 2) Evaluation of ‘dose’ impact upon off-loading, gait, balance & confidence: The prototypes will be evaluated under multiple ‘dose-ranging’ conditions to: A) quantify off-loading of plantar pressure in areas at highest risk of DFU, B) measure impact upon factors associated with fall-risk and C) establish ‘dose’ impact on participants’ gait confidence. Rationale: The team recently completed a 6 month Phase I SBIR from the ACL/National Institute for Disability, Independent Living and Rehabilitation Research. Peer reviewed results are show that the initial prototypes were able to off-load >22% of pressure by externalizing forces. Team has been awarded 3 issued US patents. If successful, this will be the first disruptive innovation in off-loading in decades and illuminates key design factors for future evaluation of robotic motor-assisted off-loading devices and sensor controlled devices.
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