Project Grant R44HD113432

THE DEVELOPMENT OF A BIMODAL WALKING-RUNNING PROSTHETIC FOOT - PROJECT SUMMARY / ABSTRACT OVER THE COURSE OF THIS TWO-YEAR PHASE II EFFORT, LIBERATING TECHNOLOGIES, INC. (LTI), ALONG WITH ITS COLLABORATORS AT FILLAUER COMPANIES AND HANGER CLINIC, WILL REFINE, EXPAND, AND TEST A BIMODAL WALKING-RUNNING FOOT THAT WOULD THEN BE POISED TO BECOME A VIABLE COMMERCIAL PRODUCT THAT CAN BE REIMBURSED UNDER THE EXISTING L-CODE REIMBURSEMENT STRUCTURE. THE GOAL OF THIS PROJECT IS TO CREATE A SINGLE FOOT THAT IS OPTIMIZED IN EACH MODE AND COMPARABLE TO A WALKING FOOT WHEN IN A WALKING MODE AND A RUNNING FOOT WHEN IN RUNNING MODE. THIS NOVEL FOOT WOULD PROVIDE LOWER LIMB AMPUTEES WHO DON'T CURRENTLY HAVE THE ACCESS TO RUNNING FEET DUE TO THE LACK OF INSURANCE COVERAGE, THE OPPORTUNITY TO PARTICIPATE IN RUNNING AND OTHER RUNNING-BASED ACTIVITIES (E.G. BASKETBALL, ETC.) TO INCREASE PHYSICAL FITNESS. IN DOING SO, THE CAESAR FOOT WOULD ALSO ALLOW FOR THE INCREASED SOCIAL PARTICIPATION AND THE PHYSICAL AND MENTAL HEALTH BENEFITS THAT ARE ASSOCIATED WITH THESE ACTIVITIES. IN ORDER TO ACHIEVE THIS GOAL, WE WILL PROGRESS AND REFINE THE BIMODAL FOOT TECHNOLOGY WITH THE ACHIEVEMENT OF THE FOLLOWING OBJECTIVES: (1) ITERATE AND OPTIMIZE THE DESIGN OF THE BIMODAL FOOT TO ACHIEVE A FULLY FUNCTIONAL PROTOTYPE READY FOR TESTING, (2) PERFORM VERIFICATION TESTING TO CONFIRM THE PROTOTYPE MEETS THE DESIGN CRITERIA, (3) VALIDATE THE PROTOTYPE IN A PILOT TAKE-HOME TRIAL AND ASSESS ITS IMPACT ON THE PHYSICAL ACTIVITY OF LOWER LIMB AMPUTEES, AND (4) START PREPARING FOR AN FDA SUBMISSION FOR THE CAESAR FOOT. THE OUTCOMES WILL BE DATA THAT VERIFY AND VALIDATE THE BIMODAL FOOT DEVICE IN THE LABORATORY AND IN THE REAL WORLD. THE PRODUCT WILL BE A HIGHLY ADVANCED, COMMERCIALLY VIABLE, VERIFIED, AND VALIDATED BIMODAL PROSTHETIC FOOT. THIS INNOVATIVE DESIGN ALLOWS US TO ADDRESS BOTH OF THE IDENTIFIED PRIMARY BARRIERS PREVENTING LLAS FROM TAKING PART IN THESE ACTIVITIES: 1) INADEQUATELY DESIGNED PROSTHESES (BY PROVIDING A FOOT WITH OPTIMIZED DESIGN, ALIGNMENT, AND BIOMECHANICS IN BOTH WALKING AND RUNNING MODES) AND 2) THE LACK OF ACCESSIBILITY FOR HIGHER ACTIVITY PROSTHESES (THE COST OF THE FOOT WOULD BE COVERED BY INSURANCE).