NCT04494555

Do Adaptable Sockets Improve Military Performance?

Completed NA Last updated 5 February 2025

What this trial tests

NA trial testing Static socket in Amputation Stump in 15 participants. Completed in 10 January 2024.

Timeline

4 November 2020

Primary endpoint
10 January 2024

10 January 2024

Quick facts

Lead sponsor	Brooke Army Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	4 November 2020
Primary completion	10 January 2024
Estimated completion	10 January 2024
Sites	1 location across United States

Drugs / interventions tested

• Static socket
• User adjusted socket
• Microprocessor-adjusting sockets

Conditions studied

• Amputation Stump — all drugs for Amputation Stump →

Sponsor

Brooke Army Medical Center

Who can join

Adults 18 to 55, any sex, with Amputation Stump. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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-adjusting, user-adjusting, and static

* Simulated combat patrol in a Virtual Realty Environment
* Military version of a Functional Capacity Evaluation
3. Characterize user preference and usability of different socket configurations

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.