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Prosthetics

Congenital/Traumatic for Amputation

Phase 3
Waitlist Available
Led By Jerome Rifkin, MS
Research Sponsored by Tensegrity Prosthetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 collections 30 days apart
Awards & highlights

Study Summary

The investigators are currently verifying early data showing that the K3 Promoter prosthetic foot affects walking efficiency or stability in transtibial, unilateral amputees when compared to their current prostheses. Phase II funds are being used to address these metrics. These studies are important basic research, however, while Tensegrity has the unique opportunity to study amputee gait and movement in the CGMA's state-of-the-art facility the investigators will expand these studies with BRDG-SPAN funding by studying the following metrics: Four Square Step Test (FSST) Amputee Mobility Predictor (AMP) Timed Up and Go Test (TUG) Quality of life (QOL) index (SF-36) Activity-specific Balance Confidence Questionnaire (ABC) 3D motion analysis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 collections 30 days apart
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 collections 30 days apart for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
3D Motion Analysis
Activity-specific Balance Confidence Questionnaire
Amputee Mobility Predictor
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dysvascular/DiabeticExperimental Treatment1 Intervention
Individuals who have had an amputation as a result of vascular disease.
Group II: Congenital/TraumaticExperimental Treatment1 Intervention
Individuals who were born with a limb deficiency or who have had a traumatic amputation.

Find a Location

Who is running the clinical trial?

Tensegrity ProstheticsLead Sponsor
1 Previous Clinical Trials
80 Total Patients Enrolled
Jerome Rifkin, MSPrincipal InvestigatorTensegrity Prosthetics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Center for Gait and Movement Analysis
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Stability and 3D Motion Study of an Experimental Prosthetic Foot
2010. "Stability and 3D Motion Study of an Experimental Prosthetic Foot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00968292.
All > Experimental
~3 spots leftby Apr 2025
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