CompletedNot Applicable

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

United States, Mexico10 participantsStarted 2017-09-15

Plain-language 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.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Local skin pressure while wearing a socket

Timeframe: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.

Skin surface temperature difference

Timeframe: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.

Gait parameter asymmetry

Timeframe: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.

Socket evaluation questionnaire

Timeframe: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for sitting, standing and walking exercises for the conventional and novel socket.

Trial details

NCT IDNCT03544853

SponsorMassachusetts Institute of Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-31

View on ClinicalTrials.gov More Amputation Stump trials

Plain-language summary

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Local skin pressure while wearing a socket

Timeframe: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.

Skin surface temperature difference

Timeframe: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.

Gait parameter asymmetry

Timeframe: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.

Socket evaluation questionnaire

Timeframe: Assessed once during (clinical) socket comfort evaluation phase. Measurements are for sitting, standing and walking exercises for the conventional and novel socket.