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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: Completed NA study, sponsored by Brooke Army Medical Center.
NCT04494555 is a NA study that has completed, run by Brooke Army Medical Center. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Angular movement between the residual limb and the prosthetic socket in the sagittal plane.
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 |
What the finished NCT04494555 record still lists
NCT04494555 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Static socket is the first listed.
NCT04494555 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04494555's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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