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Prosthetic Smart Socket Technology to Improve Patient Interaction, Usability, Comfort, Fit, and Function.

NCT03199222 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-03-20

No results posted yet for this study

Summary

A common problem for the intermediate preparatory stage of prosthetic rehabilitation is distal pressure, due to commonly compromised sensation and lack of understanding how to address it in a newly fitted prosthesis. Excessive pressure can lead to severe skin breakdown, infection, surgical revision, re-hospitalization and delayed rehab. To prevent this common problem among rehabilitating amputees, smart socket technology has been developed to better identify problems that may occur. The Smart Socket Technology including Prompting (SST+P) in this pre-clinical project proposal provides a step activity monitor and senses distal pressure, which is novel to the technology. When excessive pressure is sensed on the residual limb, it will send a signal to the user's smart phone to make an adjustment. This prompting improves patient interaction and may prevent problems as a result of common volume fluctuation and compromised sensation. The purpose of this clinical trial is to determine if the ALPS iForce smart socket technology with prompting (SST+P) will improve patient interaction, usability, comfort, fit, function and health economy outcomes compared with the standard of care (SOC) clinical practice protocols of fitting prosthetic socket interfaces

Conditions

  • Complications of the Amputated Limb

Interventions

DEVICE

Prosthetic smart socket technology with patient prompting

The smart socket technology will send feedback to the user's smartphone with suggestions including the removal or application of prosthetic socks over the residual limb or other volume management strategies to improve fit and comfort.

Sponsors & Collaborators

  • U.S. Army Medical Research Acquisition Activity

    collaborator FED

  • University of South Florida

    lead OTHER

Principal Investigators

  • Jason Highsmith, PhD · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-29
Primary Completion
2019-05-31
Completion
2019-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03199222 on ClinicalTrials.gov