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NCT04494555 · ClinicalTrials.gov registry record · NA
Do Adaptable Sockets Improve Military Performance?
A NA study, sponsored by Brooke Army Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT04494555 is a NA study that has completed, run by Brooke Army Medical Center. The registered enrollment target is 15 participants.
The verdict
NCT04494555, a NA study, has completed, sponsored by Brooke Army Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study 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 the Military Performance Lab at the CFI and the Sanders lab at the University of Washington. Data collected at the CFI will be coded, compiled, and shared with the University of Washington investigators.The objective of the research is to test if microprocessor-adjusting sockets improve Service member performance in Military specific activities compared to (a) user- operated, motor-driven adjustable sockets (i.e. sockets users adjust themselves), and (b) static (traditional) sockets. Investigators also test if microprocessor-adjusting sockets better maintain socket fit and limb fluid volume, and if self-reported outcomes are more favorable than for user-operated or static sockets. The hypotheses to be tested include: During intense Military specific tasks, compared to the user-adjusted socket and the static socket, the microprocessor-adjusting socket will: 1. minimize translational movement between the residual limb and the prosthetic socket; 2. maintain residual limb fluid volume; and 3. maximize prosthetic socket comfort. When using the microprocessor-adjusting socket compared to the user-adjusted socket and the static socket, participants will: 1. cover the greatest distance during a simulated combat patrol; 2. perform all high intensity Military specific tasks with less pain; 3. perform a simulated combat patrol nearer to uninjured levels of performance; and 4. rank usability at a level similar to the static socket. The specific aims are to: 1. Fabricate microprocessor-adjusting sockets specific for Service members and Veterans with goals of returning to high-level physical activities 2. Evaluate Military task performance in Service members with transtibial amputation using "Readiness Assessments," while wearing three socket configurations: microprocessor-adju
Interventions
- DEVICE Static socket
- DEVICE User adjusted socket
- DEVICE Microprocessor-adjusting sockets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2024-01-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04494555
The ClinicalTrials.gov registry entry for NCT04494555 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brooke Army Medical Center, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Static socket is the first listed.
NCT04494555 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04494555 about?
NCT04494555 is a clinical study titled "Do Adaptable Sockets Improve Military Performance?". 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 the Military Performance Lab at the CFI and the Sanders lab at the University of Washington. Data co...
What is the current status of trial NCT04494555?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2020-11-04. Estimated completion is 2024-01-10.
What interventions are being tested in trial NCT04494555?
The interventions under investigation include: Static socket (DEVICE), User adjusted socket (DEVICE), Microprocessor-adjusting sockets (DEVICE).
Who is sponsoring clinical trial NCT04494555?
This trial is sponsored by Brooke Army Medical Center, which has 54 total clinical trials registered on ClinicalTrials.gov.
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