Testing the ENABLE System to Improve Prosthetic Socket Fit and Comfort for Lower Leg Amputees

What this Trial Is About

This research focuses on lower limb amputees who rely on prosthetic legs to maintain an active and independent life. It aims to evaluate a new pressure sensing system designed to help prosthetists visually track pressure distribution on the residual limb, addressing challenges in creating well-fitted prosthetic sockets. The study tests the safety and effectiveness of this innovative sensing pad made with nanotube materials that change color based on pressure. Participants will undergo a series of procedures in three sets during 3-4 visits. The first set involves custom socket construction and fitting by certified prosthetists. The second set compares the new sensing pads accuracy against a commercial sensor pad by mounting both on the residual limb and measuring pressure while walking. The third set tests how well the sensing pad helps prosthetists assess socket fit under different conditions using added small pads at specific limb locations. Throughout the study, participants will be monitored with high-resolution imaging and asked to complete a comfort survey about the sensing pad. Measurements include pressure distribution during walking and a discomfort chart after the final visit. Safety measures such as a fall prevention harness are available, and participants are encouraged to self-monitor and can end procedures early if needed. Total involvement includes multiple office visits and walking trials lasting about 4 hours in total.

R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment