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Recruiting NCT04305782

NIH Release/Relock Socket

Trial Parameters

Condition Lower Limb Amputation Below Knee (Injury)
Sponsor University of Washington
Study Type INTERVENTIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-09-01
Completion 2025-09-01
Interventions
Release/Relock Socket - In LabRelease/Relock Socket - Out of LabRelease/Relock Socket & Control

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * 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 Participants involved remotely will have to meet the following inclusion criteria: * Have a spare prosthesis * No cognitive issues * Good hand dexterity and strength (not frail) * Capable of communication over a video Zoom conference call. Exclusion Criteria: * Current presence of skin breakdown * Unable to satisfy inclusion criteria

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