Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Aug 2, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how different types of prosthetic sockets can help Veterans who have had a lower limb amputation. Specifically, the study compares a new adjustable prosthetic socket, which can be changed to fit better, with a standard socket that many people currently use. The goal is to find out which type of socket helps improve movement and rehabilitation for those who have lost a leg below or above the knee.

To participate in this trial, Veterans aged 18 to 65 who have had a single leg amputation (either below the knee or above the knee) and are at a certain level of mobility can apply. Participants should not have any issues with their current prosthesis or residual limb and should be at least six months post-amputation. During the study, you'll receive one of the two types of sockets and be monitored to see how well you can move and function with it. This research aims to improve the quality of life for Veterans by helping to find the best possible prosthetic options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The investigators will enroll up to 40 Veterans
• • 20 with unilateral transtibial amputation
• • 20 with unilateral transfemoral amputation who are at or above a K2 Medicare functional classification level (MFCL) and who are 18-65 years old
• • All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation
• • Participants will be at or above a K2 MFCL, defined as a person who has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator
• Exclusion Criteria:
• • Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)