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This research has resulted in a system of sensors and software for effectively adjusting prosthetic alignment with digital numeric control. We called this suite of technologies the Prosthesis Smart Alignment Tool (ProSAT) system. Materials and Methods The ProSAT system has three components: a prosthesis-embedded sensor, an alignment tool, and an Internet-connected alignment expert system application that utilizes machine learning to analyze prosthetic alignment. All components communicate via Bluetooth. Together, they provide for numerically controlled prosthesis alignment adjustment. The ProSAT components help diagnose and guide the correction of very subtle, difficult-to-see imbalances in dynamic gait. The sensor has been cross-validated against kinetic measurement in a gait laboratory, and bench testing was performed to validate the performance of the tool while adjusting a prosthetic socket based on machine learning analyses from the software application. Results The three-dimensional alignment of the prosthetic socket was measured pre- and postadjustment from two fiducial points marked on the anterior surface of the prosthetic socket. A coordinate measuring machine was used to derive an alignment angular offset from vertical for both conditions: pre- and postalignment conditions. Of interest is the difference in the angles between conditions. The ProSAT tool is only controlling the relative change made to the alignment, not an absolute position or orientation. Target alignments were calculated by the machine learning algorithm in the ProSAT software, based on input of kinetic data samples representing the precondition and where a real prosthetic misalignment condition was known a priori. Detected misalignments were converted by the software to a corrective adjustment in the prosthesis alignment being tested. We demonstrated that a user could successfully and quickly achieve target postalignment change within an average of 0.1°. Conclusions The accuracy of a prototype ProSAT system has been validated for controlled alignment changes by a prosthetist. Refinement of the ergonomic form and technical function of the hardware and clinical usability of the mobile software application are currently being completed with benchtop experiments in advance of further human subject testing of alignment efficiency, accuracy, and user experience.

Enabling Technology for Remote Prosthetic Alignment Tuning