Clinical trial NCT04305782: NIH Release/Relock Socket
Official title: NIH Release/Relock Socket
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Limb Amputation Below Knee (Injury)
Keywords: Prosthetic Socket
Amputee
Pin Lock Prosthetic Socket
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: 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.
measure: PROMIS-Fatigue
timeFrame: Administered following out of lab testing, after at least 2 days using the test socket in out-of-lab environments.
measure: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Bioengineering
state: Washington
Study officials:
affiliation: University of Washington
name: Joan E Sanders, PhD
role: PRINCIPAL_INVESTIGATOR
References: