An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation

Launched by UNIVERSITY OF WASHINGTON · Nov 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new type of prosthetic socket designed for people who have had a leg amputated below the knee. Many amputees experience daily changes in the size of their residual limb, which can make their prosthesis uncomfortable or even painful. The goal of this research is to develop a prosthetic socket that automatically adjusts to fit these size changes throughout the day, helping to improve comfort and reduce issues like pain or skin problems.

To participate in this trial, you need to be at least 18 years old and have had a transtibial (below-the-knee) amputation for at least a year. You should also regularly use a definitive prosthesis that fits well and not have any serious skin issues or conditions that affect your sensation. Participants can expect to test this innovative socket and provide feedback on its comfort and effectiveness. This trial is currently recruiting participants of all genders who are looking for a better solution to manage their prosthetic fit throughout the day.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 or older (Prosthetists and Prosthesis Users)
• • must have certification and regularly treat patients with trans-tibial limb loss in a clinical setting (Prosthetists only)
• • had a trans-tibial amputation at least 12 months prior (prosthesis users only)
• • regularly use a definitive prosthesis with pin lock suspension and few or no pads (prosthesis users only)
• • self-report experiencing limb volume fluctuation in the past (prosthesis users only)
• • have residual limb length of at least 9 cm (prosthesis users, Aim 2 and Aim 3 only)
• • walk at least 5 continuous minutes and intermittently at least 1 hour (prosthesis users, Aim 2 and Aim 3 only)
• • capable of distinguishing socket sizes too large and too small to be tolerated (Prosthetists and Prosthesis Users)
• Exclusion Criteria:
• • Are not certified prosthetists (prosthetists only)
• • neuropathy (prosthesis users only)
• • reduced skin sensation (prosthesis users only)
• • regular use of an assisted device (prosthesis users only)
• • sores or skin breakdown on their residual limb (prosthesis users, Aim 2 and Aim 3 only)