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NCT03544853 · ClinicalTrials.gov registry record · NA

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

A NA study of Amputation Stump, sponsored by Massachusetts Institute of Technology.

Completed
Registry status
NA
Development phase
10
Enrollment target
2
Study locations

NCT03544853 is a NA study of Amputation Stump that has completed, run by Massachusetts Institute of Technology. The registered enrollment target is 10 participants. The trial reports 2 study locations across 2 states.

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The verdict

NCT03544853, a NA study of Amputation Stump, has completed, sponsored by Massachusetts Institute of Technology.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target
2
Study locations

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 Studied

Interventions

  • DEVICE Prosthetic socket for transtibial amputee

Study Locations (2)

Massachusetts

  • Massachusetts Institute of Technology, Media Lab - Cambridge

Jalisco

  • Tecnologico de Monterrey, Biomechatronics Lab - Nuevo México

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2017-09-15
Est. Completion 2022-08-31
Phase NA

What the Registry Record Tells You About NCT03544853

The ClinicalTrials.gov registry entry for NCT03544853 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts Institute of Technology, which has 24 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Amputation Stump appearing as the primary indexed condition, and to 1 intervention - of which Prosthetic socket for transtibial amputee is the first listed.

NCT03544853 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Jalisco.

Frequently Asked Questions

What is clinical trial NCT03544853 about?

NCT03544853 is a clinical study titled "Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets". 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...

What is the current status of trial NCT03544853?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2017-09-15. Estimated completion is 2022-08-31.

What conditions does trial NCT03544853 study?

This clinical trial studies the following conditions: Amputation Stump.

What interventions are being tested in trial NCT03544853?

The interventions under investigation include: Prosthetic socket for transtibial amputee (DEVICE).

Who is sponsoring clinical trial NCT03544853?

This trial is sponsored by Massachusetts Institute of Technology, which has 24 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03544853 being conducted?

This trial has 2 study locations across Massachusetts, Jalisco. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.