Laboratory and clinical tests of a prototype pressure sensor for clincial assessment of prosthetic socket fit.

Lower limb prosthetic socket fabrication is a highly refined process relying on the prosthetist's skill and experience. Despite their best efforts, patients often return with complications. Additionally, clinical application of technological advances for the quantification of biomechanical factors at the socket interface has not changed in practice. Measuring pressure levels at the stump/socket interface could provide valuable information in the process of prosthetic socket fabrication, fit and modification. This paper presents findings on the performance of a prototype capacitance pressure sensor designed for prosthetic socket use. Bench tests using compressed air were performed to measure accuracy, hysteresis and drift responses in both a flatbed chamber and a custom-modified pressure vessel. For the contoured testing, the sensors were placed on nine sites on a positive trans-tibial stump mould and enveloped with a silicone liner. Additionally, a preliminary clinical evaluation was performed with two trans-tibial amputee subjects at the nine sites during normal ambulation. Bench test results showed that the prototype capacitance sensor performed well in all categories, exhibiting a 2.42% (flatbed) and 9.96% (contoured) accuracy error, a 12.93% (flatbed) and 12.95% (contoured) hysteresis error, and a 4.40% (flatbed) and 6.20% (contoured) drift error. The clinical study showed that after three hours of continual use, no noticeable sensor drift occurred between pre and post-test calibration values. The results from this study were encouraging and the authors hope to conduct further laboratory and clinical trials to assess the influence of shear force and dynamic loading on sensor response.