Recruiting

NIH Release/Relock

Sponsor:

University of Washington

Code:

NCT04305782

Conditions

Lower Limb Amputation Below Knee (Injury)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Release/Relock Socket - In Lab

Release/Relock Socket - Out of Lab

Release/Relock Socket & Control

Study Details

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)

Study ID

NCT04305782

Start date

Sep 1, 2020

Status verified date

Apr, 2024

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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.

Interventions

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.

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.

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.

Primary outcome measure

  • Change in Limb Volume [ Time Frame: 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) [ Time Frame: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments. ]
  • PROMIS-Fatigue [ Time Frame: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments. ]
  • Socket Comfort Score (SCS) [ Time Frame: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments. ]

Central Contacts and Locations

Central contacts

Joan E Sanders, PhD

2062215872jsanders@u.washington.edu

Locations

University of Washington Bioengineering

Recruiting

Seattle, Washington, United States, 98195

Contacts

Joan E Sanders, PhD

206-221-5872jsanders@u.washington.edu

More Information

Sponsor

University of Washington

Last update posted

Apr 29, 2024

Last verified

Apr, 2024

Keywords

  • Prosthetic Socket
  • Amputee
  • Pin Lock Prosthetic Socket

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2024-04-29.