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Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets

NCT03544853 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-09-30

No results posted yet for this study

Summary

The overall goal of this study is to further develop and clinically assess a computational and data-driven design and manufacturing framework for mechanical interfaces that quantitatively produces transtibial prosthetic sockets in a faster and more cost-effective way than conventional processes. The main hypothesis of this proposal is that the novel quantitative interface is equivalent to, or better than, a conventional interface in terms of: 1) gait symmetry, 2) skin contact pressures, 3) skin surface temperature, and 4) comfort as evaluated from a questionnaire.

Conditions

  • Amputation Stump

Interventions

DEVICE

Prosthetic socket for transtibial amputee

To wear a prosthetic socket for evaluation of comfort and biomechanical metrics such as skin loading conditions.

Sponsors & Collaborators

Principal Investigators

  • Hugh M Herr, PhD · Massachusetts Institute of Technology, Media Lab

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • United States
  • Mexico

Study Locations

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Entities

Companies

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 NCT03544853 on ClinicalTrials.gov