UnknownNot Applicable

NIH Release/Relock Socket

United States100 participantsStarted 2020-09-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Limb Volume

Timeframe: 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)

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

PROMIS-Fatigue

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

Socket Comfort Score (SCS)

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

Trial details

NCT IDNCT04305782

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-01

Contact for this trial

Joan E Sanders, PhD

2062215872 jsanders@u.washington.edu

View on ClinicalTrials.gov More Lower Limb Amputation Below Knee (Injury) trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Limb Volume

Timeframe: 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)

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

PROMIS-Fatigue

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

Socket Comfort Score (SCS)

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