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 range

18 Years – 55 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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.

Trial details

NCT IDNCT04494555

SponsorBrooke Army Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-01-10

View on ClinicalTrials.gov More Amputation Stump trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

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

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.