Development of a Clinically Feasible Toolset to Optimize Performance and Mitigate Falls in Warfighters with Lower Limb Trauma and/or Loss

Our group is well positioned to succeed in producing each deliverable outlined in DHA201-D002. Our key collaborator in this proposal, Mayo Clinic, has produced an outstanding body work through many years of research and development. Their impressive body of work on fall mitigation training has already demonstrated success for warfighters recovering from limb loss. Treadmetrix has a proven track record in the design and development of highly specialized treadmill systems for world-class research/rehabilitation centers as well as elite sport organizations. Our collaborative effort will build on our previous successes by developing a field deploy-able rehabilitation system and method that will prevent falls and facilitate return to active duty or productive civilian life. By merging the most practical and effective features of existing, but costly devices, we have already conceptualized a design for our initial prototype device. We will demonstrate proof of concept within the first 6 months of our proposed project at minimal cost since nearly all of the necessary resources are in place to conduct bench top testing at our facilities. Successful demonstration of our proof of concept will drive the design, development, testing, and validation of a new prototype system designed for use in a clinical setting. Our primary design goals are to 1) ensure the field deploy-able system can successfully administer perturbation assessment and advanced fall-mitigation training/recovery programs already shown to be effective ; 2) is easily incorporated into a clinical setting; 3) include features that allow clinicians to use the system for other common billable services and 4) can be manufactured at a price point that has strong ROI potential. Upon successful validation, we will develop plans for supporting documentation, training materials, and submission for FDA regulatory approval of the system. Our work plan includes seven objectives associated with the five milestones listed below: Milestone 1 Develop Mechanical and Electrical Design Specifications • Create User Interface Wireframe and Specifications • Demonstrate Proof of Concept • Milestone 2: Design and Build a first Prototype System Milestone 3: Test and Validate the Prototype System Milestone 4: Develop Supporting Documentation and Deployment Materials • Prepare plans for FDA Submission/Approval • Milestone 5: Deploy, Test and Validate Revised System (2nd Device) Upon completion of Phase II, our plan is to evaluate the return on investment potential of our product at both DOD and civilian rehabilitation institutions. We anticipate the cost of the final product to be priced below any existing solution with similar capabilities. Our final go to market strategy will be focused on providing a strong ROI to our target customers while improving the quality of life of all warfighters that can utililze the technology.