CompletedNot Applicable

Do Adaptable Sockets Improve Military Performance?

United States15 participantsStarted 2020-11-04

Plain-language 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-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

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Motion of the Residual Limb in the Socket

Timeframe: Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.

Motion of Residual Limb in the Socket

Timeframe: Collected during physical performance sessions (Simulated Dismounted Operations (REDoP) and Functional Capacity Evaluation-Military (FCE-M)) Approximately 3 hours.

Self-report questionnaires of socket comfort

Timeframe: SCS recorded before after after each task during REDoP and FCE-M. Approximately 3 hours.

Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics

Timeframe: Assessment administered per condition. Approximately 55 minutes.

Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics

Timeframe: Recorded after each task during REDoP. Approximately 55 minutes.

Functional Capacity Evaluation-Military (FCE-M) performance metrics

Timeframe: Assessment administered per condition. Approximately 30 minutes.

Functional Capacity Evaluation-Military (FCE-M) performance metrics

Trial details

NCT IDNCT04494555

SponsorBrooke Army Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-01-10

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