Do Adaptable Sockets Improve Military Performance?

Amputation Stump Clinical Trial

Official title:

Do Adaptable Sockets Improve Military Performance?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04494555
• Other study ID #: BAMC C.2020.007
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2020
• Est. completion date: August 14, 2023

Study information

• Verified date: July 2022
• Source: Brooke Army Medical Center
• Contact: Molly Baumann, PhD
• Phone: 6144297945
• Email: molly.baumann.civ[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The purpose of the proposed research is to evaluate the use of microprocessor-adjusting sockets during "Readiness Assessments" of Military tasks performed by Service members with transtibial amputation.

Participants will come to the Center For the Intrepid (CFI) for up to 10 visits to complete a pre-monitoring session (assess residual limb health and gather information regarding limb fluid volume); socket fitting session(s) (fitting of three sockets- static socket, a user-adjusted socket, and microprocessor-adjusting socket); and for military readiness assessments for each of the three socket conditions.

Data across the three socket conditions (static socket, user adjusted socket, and Microprocessor-adjusting sockets) will be tested for normality. When it normality can be assumed, a single factor repeated measures ANOVA will test between socket conditions. Mauchly's Test of Sphericity was be used to test if the variance is significantly different across all of the conditions. If the sphericity condition is violated, a Greenhouse-Geisser adjustment will be applied. When a significance effect is detected, pairwise comparisons using a Tukey post-hoc will be performed to determine which conditions are significantly different. When normality cannot be assumed, a Kruskal-Wallis H test will be used. When a significance effect is detected, pairwise comparisons using a Mann-Whitney post-hoc while adjusting the p-value for multiple comparisons will be performed to determine which conditions are significantly different. Statistical significance will be set to p<0.05

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amputation Stump

Intervention

Device:
• Static socket
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.
• User adjusted socket
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.
• Microprocessor-adjusting sockets
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.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center, Center for the Intrepid	Fort Sam Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Brooke Army Medical Center	University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (44)

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics	Total distance traversed during REDoP assessment.	Assessment administered per condition. Approximately 55 minutes.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics	Marksmanship during the simulated ambushes.	Recorded after each task during REDoP. Approximately 55 minutes.
Secondary	Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics	Heart rate.	Recorded during REDoP. Approximately 55 minutes.
Secondary	Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics	Rating of perceived exertion. A standard 6-20 Borg scale will be used to collect the individual's Rating of Perceived Exertion. Subject's will be asked throughout the session to "rate the difficulty of the task" based on their fatigue level using the Borg scale.	Recorded after each task during REDoP. 5-10 sec to respond and approximately 55 minutes in total.
Secondary	Functional Capacity Evaluation-Military (FCE-M) performance metrics	Heart rate.	Recorded during FCE-M. Approximately 30 minutes.
Secondary	Functional Capacity Evaluation-Military (FCE-M) performance metrics	Rating of perceived exertion. A standard 6-20 Borg scale will be used to collect the individual's Rating of Perceived Exertion. Subject's will be asked throughout the session to "rate the difficulty of the task" based on their fatigue level using the Borg scale.	Recorded after each task during FCE-M. 5-10 sec to respond and approximately 30 minutes in total.