NIH Release/Relock Socket

Not Applicable

Recruiting

• Conditions: Lower Limb Amputation Below Knee (Injury)
• Interventions: Device: Release/Relock Socket - In Lab; Device: Release/Relock Socket - Out of Lab; Device: Release/Relock Socket & Control

• Registration Number: NCT04305782
• Lead Sponsor: University of Washington

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-12
• Study Start: 2020-09-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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Exclusion Criteria

• Current presence of skin breakdown
• Unable to satisfy inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Release/Relock Socket - In Lab	Release/Relock Socket - In Lab	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.
Release/Relock Socket - Out of Lab	Release/Relock Socket - Out of Lab	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.
Release/Relock Socket & Control	Release/Relock Socket - In Lab	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.
Release/Relock Socket & Control	Release/Relock Socket & Control	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.

Primary Outcome Measures

Name	Time	Method
Change in Limb Volume	Change from baseline period (no release/relock) to test period (release/relock), commonly each 1 hour long and separated by a seated period of approximately 30 minutes	Limb volume fluctuations will be measured in real-time as socket release/relock strategies are tested. This will be accomplished using a portable bioimpedance device with thin sticky electrodes that are placed on the residual limb. Specifically, the change in limb volume will be assessed from a baseline period where no socket adjustments are made to another period within the same test session where socket adjustments are made.
Prosthesis Evaluation Questionnaire (PEQ)	Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.	Participants will be asked to fill out a questionnaire related to their experience using the test socket out of lab in various test configurations. Each question on the PEQ can receive a score form 0 to 100, with higher scores indicating greater satisfaction.
PROMIS-Fatigue	Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.	Participants will be asked to fill out a questionnaire related to their experience using the test socket out of lab in various test configurations. Each PROMIS-Fatigue question asks participants to rank on a scale from 1 to 5 (categorical options), with higher scores indicating greater level of fatigue.
Socket Comfort Score (SCS)	Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.	Participants will be asked to rank their comfort while using the test socket out of lab in various test configurations. The SCS ranges from 0 to 10 (categorical), with higher scores indicating greater level of comfort.

Trial Locations

Locations (1)

University of Washington Bioengineering; 🇺🇸 Seattle, Washington, United States