RecruitingNot ApplicableNCT04305782

NIH Release/Relock Socket

Sponsor

University of Washington

Enrollment

100 participants

Start Date

Sep 1, 2020

Study Type

INTERVENTIONAL

Conditions

Lower Limb Amputation Below Knee (Injury)

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

Inclusion Criteria10

Had trans-tibial amputation at least 18 months prior to enrollment
Regularly wear a definitive prosthesis for at least 7 hours per week
Have a residual limb length of at least 9 cm
K2 or higher MFCL
Able to walk continuously with a prosthesis for at least 2 minutes at a time
Sit, stand, and negotiate a step of 5.0 cm
Have a spare prosthesis
No cognitive issues
Good hand dexterity and strength (not frail)
Capable of communication over a video Zoom conference call.

Exclusion Criteria1

Current presence of skin breakdown

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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.