NCT04305782

NIH Release/Relock Socket

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Limb fluid volume changes that can occur in the residual limb of a lower-limb amputee can result in changes in socket fit that lead to discomfort, skin injuries, and reduced mobility. It is known that limb fluid volume fluctuations can be reduced for some people by intermittently removing (doffing) the socket throughout the day. It is believed that partially doffing the socket may have a similar benefit, and could be made more convenient thereby promoting easier compliance for prosthetic users. The goal of the research is to create and evaluate a new technology for management of daily residual limb fluid volume fluctuation. The technology enables partial doffing through the release and relock of a socket panel and the prosthetic pin used to hold the limb in place. The expected outcomes are an enhanced understanding of how socket adjustments after activity facilitate limb fluid volume recovery, subsequent fluid retention, and improved socket fit.

Conditions

• Lower Limb Amputation Below Knee (Injury)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2025-09-01
• Completion: 2025-09-30
• First posted: 2020-03-12
• Last updated: 2024-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study