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

Completed · Not applicable

Conditions studied: Amputation Stump

In brief

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.

Key facts

Study ID

NCT03544853

Run by

Massachusetts Institute of Technology

People needed

10

Starts

2017-09-15

Expected to finish

2022-08-31

Last updated by the study team

2022-09-30

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age: 18-64 years old
• Amputation type: Transtibial amputation (bilateral or unilateral) which took place >1 year prior to study
• Activity or K-level: At least K3
• Socket quality: The subject's conventional socket(s) should be deemed of high quality and comfortable
• MRI safety: Subjects should be able to undergo MRI

Where it is running

• Massachusetts Institute of Technology, Media Lab — Cambridge, Massachusetts, United States
• Tecnologico de Monterrey, Biomechatronics Lab — Nuevo México, Jalisco, Mexico

Full record on ClinicalTrials.gov

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