NCT04230512

Assessment of a Hybrid Pump for Vacuum Suspension of Prosthetic Sockets for Persons With Lower Limb Loss to Characterize the Effects of Added Movement on Socket-reaction Torques

Hybrid Electrical-Mechanical Pump for Vacuum Suspension of Prosthetic Sockets

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Amputation

Interventions

Type	Name	Description
OTHER	Pump prototype	Effects of pump function on gait

Timeline

• Start date: 2020-04-04
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2020-01-18
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States