Study Comparing the Access Socket Flexible Prosthetic Socket with Standard Rigid Socket in Adults with Transtibial Amputation

What this Trial Is About

Researchers are evaluating a new type of prosthetic socket called the Access Socket AS for adults with transtibial amputation, which affects the lower leg below the knee. This study compares the AS to the standard rigid socket RS to see if it improves comfort, function, and mobility. The AS combines rigid carbon-fiber areas with flexible urethane-resin zones to enhance comfort and pressure distribution while maintaining support for walking. This study is a multicenter, randomized, open-label crossover trial involving 25 adults. Participants will wear each type of socket for about 4 weeks, after a 1-2 week adaptation period, in a randomized order. One group starts with the RS and then switches to the AS, while the other group starts with the AS and then switches to the RS. Both sockets are made from the same mold to ensure the same internal shape the difference lies in the materials used. The study includes an optional follow-up visit one month after the second socket period for those who choose to keep the AS. During the study, participants will attend four visits over approximately 14 to 21 weeks. Researchers will assess function using the Patient Specific Functional Scale PSFS at the end of each socket wear period. Other measures include comfort, satisfaction, psychosocial adjustment, mobility, and prosthesis utility. Safety and patient choice of socket at study completion will also be monitored. Participants must be adults with transtibial amputation currently using a rigid socket and able to provide informed consent.

Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis