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Clinical Trial Summary

Prostheses can be suspended from the amputated limb using a variety of techniques, such as straps and suction. Suspending the prosthesis by creating a vacuum between the prosthetic socket and limb using a pump has benefits over other techniques including improved limb health and mobility. A new pump design will be tested by prosthesis users in the laboratory to verify its functionality during walking.


Clinical Trial Description

Human subject testing will involve a cross-sectional, repeated measures study consisting of a single 3 hour visit wherein participants will initially stand and then continuously walk at their self-selected speed for ten minutes on a level treadmill with the prototype under two randomly presented conditions of the mechanical system: 1) fully functional, and 2) locked to restrict axial displacement. After written informed consent is obtained, information on socket comfort and mobility capability will be collected. A load-cell will be installed proximal to the prototype and in-line with the prosthesis to measure instantaneous socket-reaction moments. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04230512
Study type Interventional
Source VA Office of Research and Development
Contact Matthew J Major, PhD
Phone (312) 569-6166
Email Matthew.Major2@va.gov
Status Recruiting
Phase N/A
Start date April 4, 2020
Completion date September 29, 2024

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