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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: Completed NA study of Amputation Stump, sponsored by Massachusetts Institute of Technology.
NCT03544853 is a NA study of Amputation Stump that has completed, run by Massachusetts Institute of Technology. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Local skin contact pressures (in Newton per square meter) are assessed using pressure sensors positioned on the skin surface. Local pressures relate to comfort which is the topic of investigation. These measurements are performed during the (clinical) socket comfort evaluation phase which is typically 3 months after the initial data acquisition phase for each subject. Measurements take place once and in a single session. As such only a single time point is investigated (the time point of the exp
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
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-09-15 |
| Est. Completion | 2022-08-31 |
| Phase | NA |
What the finished NCT03544853 record still lists
NCT03544853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03544853's enrollment target sits among peer trials
10 1927th of 2000 higher than 26 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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