1 Clinical Trials for Various Conditions
A common problem for the intermediate preparatory stage of prosthetic rehabilitation is distal pressure, due to commonly compromised sensation and lack of understanding how to address it in a newly fitted prosthesis. Excessive pressure can lead to severe skin breakdown, infection, surgical revision, re-hospitalization and delayed rehab. To prevent this common problem among rehabilitating amputees, smart socket technology has been developed to better identify problems that may occur. The Smart Socket Technology including Prompting (SST+P) in this pre-clinical project proposal provides a step activity monitor and senses distal pressure, which is novel to the technology. When excessive pressure is sensed on the residual limb, it will send a signal to the user's smart phone to make an adjustment. This prompting improves patient interaction and may prevent problems as a result of common volume fluctuation and compromised sensation. The purpose of this clinical trial is to determine if the ALPS iForce smart socket technology with prompting (SST+P) will improve patient interaction, usability, comfort, fit, function and health economy outcomes compared with the standard of care (SOC) clinical practice protocols of fitting prosthetic socket interfaces