NIH Release/Relock Socket

NCT04305782 | Recruiting FDA Device

• 2 other identifiers: STUDY000068742R01HD060585-08
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lower Limb Amputation Below Knee (Injury)

Keywords

Prosthetic Socket; Amputee; Pin Lock Prosthetic Socket

Outcome Measures

Primary Outcomes (4)

• Change in Limb Volume

  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.

  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

• Prosthesis Evaluation Questionnaire (PEQ)

  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.

  Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.

• PROMIS-Fatigue

  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.

  Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.

• Socket Comfort Score (SCS)

  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.

  Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.

Study Arms (3)

Release/Relock Socket - In Lab

EXPERIMENTAL

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.

Device: Release/Relock Socket - In Lab

Release/Relock Socket - Out of Lab

EXPERIMENTAL

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.

Device: Release/Relock Socket - Out of Lab

Release/Relock Socket & Control

EXPERIMENTAL

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.

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

Interventions

Release/Relock Socket - In Lab DEVICE

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.

Release/Relock Socket & Control; Release/Relock Socket - In Lab

Release/Relock Socket - Out of Lab DEVICE

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.

Release/Relock Socket - Out of Lab

Release/Relock Socket & Control DEVICE

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.

Release/Relock Socket & Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Have a spare prosthesis
• No cognitive issues
• Good hand dexterity and strength (not frail)
• Capable of communication over a video Zoom conference call.

You may not qualify if:

• Current presence of skin breakdown

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Washington Bioengineering

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Drainage

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Joan E Sanders, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan E Sanders, PhD

CONTACT

2062215872; jsanders@u.washington.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Bioengineering

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 12, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2025
• Study Completion: September 30, 2025
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

US (1)