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Prosthetic socket for transtibial amputee for Amputation Stumps

N/A
Waitlist Available
Led By Hugh M Herr, PhD
Research Sponsored by Massachusetts Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed once during (clinical) socket comfort evaluation phase. measurements are for standing and walking exercises for the conventional and novel socket.
Awards & highlights

Study Summary

This trial will test a new way of making prosthetic sockets that is faster and cheaper than the current method. They will test if the new sockets are just as good or better than the current ones in terms of pressure on the skin, how the patient walks, how much energy it costs to walk, skin irritation, and comfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed once during (clinical) socket comfort evaluation phase. measurements are for standing and walking exercises for the conventional and novel socket.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed once during (clinical) socket comfort evaluation phase. measurements are for standing and walking exercises for the conventional and novel socket. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gait parameter asymmetry
Local skin pressure while wearing a socket
Thermography
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prosthetic socket evaluationExperimental Treatment1 Intervention
Intervention: Prosthetic socket for transtibial amputee. A subject's conventional prosthetic socket is compared to a novel prosthetic socket designed as part of the research. For standing and walking exercises the following will be assessed. 1) local skin contact pressures, 2) metabolic power, 3) gait parameters (symmetry indices for joint angles, positions, torques, and also ground reaction forces), and 4) the socket evaluation questionnaire.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prosthetic socket for transtibial amputee
2017
N/A
~10

Find a Location

Who is running the clinical trial?

Massachusetts Institute of TechnologyLead Sponsor
97 Previous Clinical Trials
12,729,977 Total Patients Enrolled
National Institute for Biomedical Imaging and Bioengineering (NIBIB)NIH
89 Previous Clinical Trials
19,774 Total Patients Enrolled
Hugh M Herr, PhDPrincipal InvestigatorMassachusetts Institute of Technology, Media Lab
2 Previous Clinical Trials
38 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets
2017. "Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03544853.
~1 spots leftby Apr 2025
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