Improving the health status of dysvascular amputees by deploying digital prosthetic interface technology in combination with exercise intervention

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Project Summary/Abstract Persons with dysvascular amputations are at great risk for life-threatening cardiovascular disease. While exercise has been shown to reduce this risk, often times dysvascular amputees are unable to perform physical activity due to pressure lesions and sores generated by poor prosthetic socket fit. This Small Business Innovation Research (SBIR) Phase-II project proposes the deployment of a computationally derived transtibial prosthetic interface technology to promote adherence to a tele-health exercise intervention for persons with dysvascular amputation. The prosthetic interface is digitally generated using a computational framework focused on the creation of a liner and socket quantitatively derived from a biophysical model of the amputated residuum. Previously developed at MIT and productized at Bionic Skins, this data-driven design and manufacturing framework is based on a clear scientific rationale to maximize comfort and avoid tissue injury by diminishing areas of high contact pressure between the residuum and interface. The proposed SBIR Phase-II activities are sorted into four specific aims. In Aim 1, subjects with dysvascular transtibial unilateral amputations will be recruited and be separated evenly into two groups. Data on Group 2 will be collected using Computed Tomography (CT) and detailed biomechanical models will be derived from each scan for use in the computational framework. In Aim 2, Finite Element Analysis (FEA) will be combined with test socket evaluations to optimize and then fabricate a definitive liner and socket for all subjects in Group 2 using the Digital Design to Digital Manufacturing pipeline. In Aim 3, initial biomechanical assessments of all socket interfaces (digitally designed and conventional) for both cohorts will be performed using intra-socket interface pressure measurements, thermal imaging measurements of the residuum, a socket evaluation questionnaire, and prosthetist tissue evaluation. In Aim 4 a randomized (superiority) clinical trial will be conducted to compare clinical outcomes over a period of 12 months in dysvascular unilateral transtibial amputees participating in an exercise-based intervention program when using Bionic Skins’ digital prosthetic interface technology vs. a socket that is manufactured using a traditional (artisanal) technique. The assessments outlined in Aim 3 will be performed periodically over the twelve months to gather longitudinal data. Significant differences between the two groups will be reported. The long-term commercial goal of the project is to generate evidence that Bionic Skins’ computationally personalized prosthetic interface is superior to conventional interfaces in comfort, fit, and maintenance of good tissue health and thus a viable option to include in various exercise-related interventions for persons with below-knee amputations, or as an everyday prosthetic interface option.