Study of an Automatic-Adjusting Prosthetic Socket for Adults With Below-Knee Amputations Comparing Auto-Adjusting, Manual-Adjusting, and Standard Prosthetic Sockets

What this Trial Is About

This research focuses on people with transtibial below-knee amputations who experience daily changes in the size of their residual limb. These changes can cause discomfort and poor prosthesis fit, leading to problems such as pain and skin breakdown. The study aims to evaluate whether an automatically adjusting prosthetic socket can provide better comfort and fit compared to a manually adjusting socket or a standard care control. Participants will test three different socket types an automatic-adjusting socket that changes fit using built-in panels controlled automatically or via a key fob, a manual-adjusting socket, and a standard care socket where adjustments are made by adding or removing socks. Each socket will be worn for two weeks, separated by two-week washout periods. The study includes initial assessments, socket fabrication, training on socket use, and check-in visits during each test period. Throughout the study, participants will complete self-report questionnaires about comfort, convenience, fatigue, and experiences with the socket. Residual limb health will be assessed at multiple points. Researchers will also monitor prosthesis wear time, activity levels, and socket fit variability. The total study duration includes repeated testing with each socket type and follow-ups, lasting up to one year for outcome measurements.

An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation