Microprocessor-adjusting sockets for Amputation Stumps

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Amputation Stumps
Microprocessor-adjusting sockets - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare microprocessor-adjusting sockets to user-adjusted and static sockets to see if they improve performance in military activities and are more comfortable.

Treatment Effectiveness

Study Objectives

5 Primary · 2 Secondary · Reporting Duration: Recorded after each task during REDoP. 5-10 sec to respond and approximately 55 minutes in total.

Hour 3
Total score on the Post-Study System Usability Questionnaire
Hour 3
Motion of Residual Limb in the Socket
Motion of the Residual Limb in the Socket
Hour 3
Bioimpedance Monitoring
Recorded after each task during FCE-M. 5-10 sec to respond and approximately 30 minutes in total.
Functional Capacity Evaluation-Military (FCE-M) performance metrics
Recorded after each task during REDoP. 5-10 sec to respond and approximately 55 minutes in total.
Readiness Evaluation during Simulated Dismounted Operations (REDoP) performance metrics
Hour 3
Self-report questionnaires of socket comfort

Trial Safety

Trial Design

1 Treatment Group

Adaptable Prosthetic Socket
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Microprocessor-adjusting sockets · No Placebo Group · N/A

Adaptable Prosthetic SocketExperimental Group · 3 Interventions: User adjusted socket, Microprocessor-adjusting sockets, Static socket · Intervention Types: Device, Device, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: recorded after each task during redop. 5-10 sec to respond and approximately 55 minutes in total.

Who is running the clinical trial?

Brooke Army Medical CenterLead Sponsor
109 Previous Clinical Trials
26,986 Total Patients Enrolled
University of WashingtonOTHER
1,586 Previous Clinical Trials
1,566,492 Total Patients Enrolled
Walter L Childers, PhDPrincipal InvestigatorExtremity Trauma and Amputation Center of Excellence (EACE)

Eligibility Criteria

Age 18 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or female age 18 - 55 years.
You are authorized to receive care at the Center for the Intrepid.
You have experience performing military relevant tasks (e.g., Active duty Service Member or Veteran).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References