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.
Diabetic Foot Ulcer is the leading cause of foot amputation, its prevalence is increasing dramatically and it is 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. A new class of technology is arising - the wearable rehabilitation robot - that will provide a revolutionary improvement in wound healing, however, until now these devices have been too costly and unsuitable for large scale distribution. The proposed solution introduces a novel exo- skeleton which can be deployed at a very low cost without a motor and was shown in proof of concept testing to off-load clinically significant pressure in areas at highest risk for ulceration, thereby providing a new and disruptive option for the prevention of Diabetic Foot Ulcer and thereby the reduction of Amputation and risk of mortality.
