Do Adaptable Sockets Improve Military Performance?

NCT04494555 | Completed

• 1 other identifier: BAMC C.2020.007
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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:

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

Conditions

Amputation Stump

Keywords

amputation; bioimpedance; prosthetic socket; transtibial

Outcome Measures

Primary Outcomes (8)

• Motion of the Residual Limb in the Socket

  Angular movement between the residual limb and the prosthetic socket in the sagittal plane.

  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

  Translational movement between the residual limb and the prosthetic socket about the longitudinal axis of the prosthetic socket.

  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

  Change in Socket Comfort Score (SCS) across the Readiness Evaluation during Simulated Dismounted Operations (REDoP) and modified Functional Capacity Evaluation-Military (FCE-M), 0-10 scale.

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

• Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics

  Total distance traversed during REDoP assessment.

  Assessment administered per condition. Approximately 55 minutes.

• Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics

  An 11-point (0-10) verbal numerical rating scale (NRS) for pain will be displayed and used to collect the individual's pain level throughout REDoP.

  Recorded after each task during REDoP. Approximately 55 minutes.

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

  Time to complete each sub-task of the FCE-M.

  Assessment administered per condition. Approximately 30 minutes.

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

  An 11-point (0-10) verbal numerical rating scale (NRS) for pain will be displayed and used to collect the individual's pain level throughout FCE-M.

  Recorded after each task during REDoP. Approximately 30 minutes.

• Total score on the Post-Study System Usability Questionnaire

  This is a 19-item instrument for assessing user satisfaction with system usability. The items are 7-point graphic scales, anchored at the ends with the terms "Strongly agree" for 1, "Strongly disagree" for 7, and a "Not applicable" (N/A) point outside the scale.

  After each of the sessions with each socket condition, approximately 3 hours.

Secondary Outcomes (5)

• Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics

  Recorded after each task during REDoP. Approximately 55 minutes.

• Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics

  Recorded during REDoP. Approximately 55 minutes.

• Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics

  Recorded after each task during REDoP. 5-10 sec to respond and approximately 55 minutes in total.

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

  Recorded during FCE-M. Approximately 30 minutes.

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

  Recorded after each task during FCE-M. 5-10 sec to respond and approximately 30 minutes in total.

Study Arms (1)

Adaptable Prosthetic Socket

EXPERIMENTAL

Using measurements of limb-socket displacements from sensors embedded within the socket wall, adaptable sockets make small adjustments to socket size so as to maintain consistent displacements while prosthesis users are active. They do not require the user to stop activity or to touch or modify the prosthesis, and they do not distract users from their objectives.

Device: Static socket; Device: User adjusted socket; Device: Microprocessor-adjusting sockets

Interventions

Static socket DEVICE

For the static socket configuration, both the microprocessor control and user control are disabled, and the panels are positioned in their flush configuration to create the user's as-prescribed socket shape.

Adaptable Prosthetic Socket

User adjusted socket DEVICE

Sockets are configured for user control by disabling automated control and enabling push buttons on the side of the socket to adjust socket size. Each button push effects a socket size change of approximately 0.3% volume. An upper button effects a socket size increase, and a lower button a socket size decrease. The buttons are countersunk so reduce risk of accidental pushes, and they do not function unless the user is stationary. An additional button push will not be executed until motor motion from the prior push has been completed. If a button is continuously held then the motor will continue moving until the button is released. Limits are set on cable length to ensure that sockets sizes threatening to the user's residual limb (too tight) are avoided. The push buttons effect inner-loop control that operates completely within the mechanism, achieving high-resolution adjustment of cable length with minimal error.

Adaptable Prosthetic Socket

Microprocessor-adjusting sockets DEVICE

A strategy for automatically controlling the size of the socket during walking to compensate for unknown changes in limb volume will be used. The controller is essentially a regulator that continuously measures socket "fit," and adjusts the socket to maintain a prescribed reference set point. Because the fit is automatically sustained, the prosthesis user is unaware of its operation.

Adaptable Prosthetic Socket

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• University of Washington: collaborator

Study Sites (1)

Brooke Army Medical Center, Center for the Intrepid

Fort Sam Houston, Texas, 78234, United States

Location

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Study Officials

• Walter L Childers, PhD

  Extremity Trauma and Amputation Center of Excellence (EACE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: This is a repeated measures prospective study.

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: July 31, 2020
• Study Start: November 4, 2020
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)