Status:
COMPLETED
Do Adaptable Sockets Improve Military Performance?
Lead Sponsor:
Brooke Army Medical Center
Collaborating Sponsors:
University of Washington
Conditions:
Amputation Stump
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This is a repeated measures prospective study and is no greater than a minimal risk study. All study procedures will be conducted at the Center for the Intrepid (CFI) through collaborative efforts of ...
Detailed Description
The purpose of the proposed research is to evaluate the use of microprocessor-adjusting sockets during "Readiness Assessments" of Military tasks performed by Service members with transtibial amputatio...
Eligibility Criteria
Inclusion
- Males and females age 18 - 55 years
- Authorized to receive care at the Center for the Intrepid
- Unilateral or bilateral transtibial amputation
- Have experience performing military relevant tasks (e.g., Active duty Service Member or Veteran)
- Current prosthesis user
- Ability to comply with instructions associated with functional testing
- Able to provide written informed consent
Exclusion
- Self-reported inability to safely ambulate for a minimum of twenty minutes continuously and unassisted
- History of medical or psychological disease that would preclude safe gait, load carriage, physical, or cognitive functional training or testing within a virtual reality environment as determined by the provider screening the subject (i.e. moderate/severe traumatic brain injury, stroke, renal failure, cardiac or pulmonary problems disease, severe anemia, and other medical conditions)
- Any injury sustained to the upper extremity which would preclude safe physical performance testing
- Self-reported Blindness
- Self-reported Pregnancy
- Self-reported Active infection
- Weight above 250 lbs (114 kg)
- Residual limb length shorter than 9cm as this is the minimum distance necessary to attach the bio-impendence sensors
- Score greater than 20% on the Modified Oswestry Low Back Pain Questionnaire as this will indicate greater than minimal disability due to low back pain.
Key Trial Info
Start Date :
November 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04494555
Start Date
November 4 2020
End Date
January 10 2024
Last Update
February 5 2025
Active Locations (1)
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1
Brooke Army Medical Center, Center for the Intrepid
Fort Sam Houston, Texas, United States, 78234