NIH Release/Relock Socket

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 1, 2020

Primary Completion Date

September 1, 2025

Study Completion Date

September 30, 2025

Conditions
Lower Limb Amputation Below Knee (Injury)
Interventions
DEVICE

Release/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.

DEVICE

Release/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.

DEVICE

Release/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.

Trial Locations (1)

98195

RECRUITING

University of Washington Bioengineering, Seattle

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of Washington

OTHER