RecruitingNot ApplicableNCT04305782

NIH Release/Relock Socket


Sponsor

University of Washington

Enrollment

100 participants

Start Date

Sep 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new prosthetic socket system — called the NIH Release/Relock Socket — designed for people who have had a below-knee (trans-tibial) amputation. The socket is the part of a prosthetic limb that connects to the residual limb. Traditional sockets can be hard to put on and take off and may not provide optimal comfort or stability. This new design aims to make it easier to don and doff (put on and remove) the prosthesis while maintaining secure attachment during walking. Participants will test the new socket design in both in-person and remote (virtual) settings. Researchers will assess comfort, security, ease of use, and walking performance compared to standard sockets. Both in-person and remote participation options are available. You may be eligible if you: - Had a below-knee (trans-tibial) amputation at least 18 months ago - Regularly wear a prosthesis for at least 7 hours per week - Have a residual limb at least 9 cm in length - Are classified as K2 mobility level or higher (capable of limited or unlimited community ambulation) - Can walk continuously with a prosthesis for at least 2 minutes and can sit, stand, and step up 5 cm For remote participation, you also need to: - Have a spare prosthesis available - Have no cognitive issues - Have adequate hand dexterity and strength - Be able to participate via video call (Zoom) You may NOT be eligible if you: - Currently have skin breakdown on your residual limb - Cannot meet the inclusion criteria above Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICERelease/Relock Socket - In Lab

The participants will operate the test socket in one of two test conditions: (1) pin re-lock before panel re-lock and (2) panel re-lock before pin re-lock. Participants will test each of the two conditions in a random order, in lab, following a structured protocol. Tests will determine if the order of the re-lock mechanisms influences changes in limb volume.

DEVICERelease/Relock Socket - Out of Lab

The participants will operate the test socket in one of two test conditions: (1) pin re-lock before panel re-lock and (2) panel re-lock before pin re-lock. Participants will test each of the two conditions in a random order, out of lab, with no structured protocol. Tests will determine if the order of the re-lock mechanisms changes participant experience.

DEVICERelease/Relock Socket & Control

The participants will operate the test socket in one of two test conditions: (1) release/relock mechanisms enabled and (2) release/relock mechanisms disabled. Participants will test each of the two conditions in a random order, out of lab, with no structured protocol. Tests will determine how the novel release/relock mechanisms compare against traditional socket release methods.


Locations(1)

University of Washington Bioengineering

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04305782


Related Trials