SBIR/STTR Award attributes
Project SummaryAbstract Relatedness to MissionApplication aligns with multipleNINR SBIR goalsGTechnologies to treat chronic wounds that fail to healspecificallydiabetic ulcersBDevices that improve the acceptance and use of assistive devicesBDevices that improve delivery of care to persons who have restricted movement due toperipheralvascular diseaseto allow them to better self manageDTechnologies to assist in health promotion and prevention Medical needThis application is towards rehabilitation andampsecondary prevention of Diabetic Foot UlcerDFUDFU is more costly than the most expensive cancerit is the leading cause of lower limb amputationsand survivors of lower limb amputation have a higher mortality rate than half of the topcancersInventionThe device is focused on secondary prevention of DFU by reducing pressure on the areas of the foot at greatest risk for ulcerationWith patient inputteam has designed a novel assistive device that off loads pressure from the foot by deploying a disruptive design for rehabilitation roboticsIt integrates structural exoskeletons and exo tendons to externalize lower limb forces outside of the bodyPI holds US patents on the exoskeletons deployed as a low cost easily manufactured non powered device and a motorized robotic versionIn a peer reviewed publication of team s initial proof of concept testingthe device demonstrated clinically significant off loading of greater thanwhich is similar to the off loading achieved through surgical interventionThe device also received positive patient feedback regarding gait stabilityAimPrototype refinement and instrumentationInitial proof of concept demonstrated ability to re route force outside a patient s bodyNowteam must create instrumented prototypes with specific ability to precisely adjust thedoselevel of spring force and the bio mechanical geometry at which these forces engageAimEvaluation ofdoseimpact upon off loadinggaitbalance andampconfidenceThe prototypes will be evaluated under multipledose rangingconditions toAquantify off loading of plantar pressure in areas at highest risk of DFUBmeasure impact upon factors associated with fall risk and Cestablishdoseimpact on participantsgait confidenceRationaleThe team recently completed amonth Phase I SBIR from the ACL National Institute for DisabilityIndependent Living and Rehabilitation ResearchPeer reviewed results are show that the initial prototypes were able to off load andgtof pressure by externalizing forcesTeam has been awardedissued US patentsIf successfulthis 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 Project Narrative Diabetic Foot Ulcer is the leading cause of foot amputationits prevalence is increasing dramatically and it is more expensive burden to the US healthcare system than lung cancerthose with foot amputation have a higher mortality rate than half of the topcancersA new class of technology is arisingthe wearable rehabilitation robotthat will provide a revolutionary improvement in wound healinghoweveruntil now these devices have been too costly and unsuitable for large scale distributionThe proposed solution introduces a novel exoskeleton 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 ulcerationthereby providing a new and disruptive option for the prevention of Diabetic Foot Ulcer and thereby the reduction of Amputation and risk of mortality
