NIH Release/Relock Socket

University of Washington

Status: Enrolling

Conditions: Lower Limb Amputation Below Knee (Injury)

Treatments: Device: Release/Relock Socket - Out of Lab; Device: Release/Relock Socket - In Lab; Device: Release/Relock Socket & Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04305782

2R01HD060585-08 (U.S. NIH Grant/Contract)

STUDY00006874

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Release/Relock Socket - In Lab

Experimental group

Description:

The test socket will be operated by the participant in lab, following a structured protocol. This arm focuses on the order effects on the re-lock panel and pin mechanisms on limb volume.

Treatment:

Device: Release/Relock Socket - In Lab

Release/Relock Socket - Out of Lab

Experimental group

Description:

The test socket will be operated by the participant out of lab, with no structured protocol. This arm focuses on the effects of the re-lock panel and pin mechanisms on participant comfort.

Treatment:

Device: Release/Relock Socket - Out of Lab

Release/Relock Socket & Control

Experimental group

Description:

The test socket will be operated by the participant out of lab, with no structured protocol. This arm focuses on the comparing participant experience using the novel mechanism versus traditional socket mechanisms.

Treatment:

Device: Release/Relock Socket & Control

Device: Release/Relock Socket - In Lab