Status:
RECRUITING
NIH Release/Relock Socket
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Lower Limb Amputation Below Knee (Injury)
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- Current presence of skin breakdown
- Unable to satisfy inclusion criteria
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04305782
Start Date
September 1 2020
End Date
September 30 2025
Last Update
April 29 2024
Active Locations (1)
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1
University of Washington Bioengineering
Seattle, Washington, United States, 98195