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Prosthetic Foot Testing for Amputation

N/A
Recruiting
Led By David C Morgenroth, MD
Research Sponsored by Seattle Institute for Biomedical and Clinical Research
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 administered at follow up using the actual prosthetic feet (approximately two hours)
Awards & highlights

Study Summary

This trial will test the effects of 3 different prosthetic feet on stability and falls-related outcomes in 50 Veterans with transfemoral amputations.

Who is the study for?
This trial is for Veterans with a below-knee amputation on one leg who've been walking with a prosthetic limb for at least six months. They must have a well-fitting prosthetic socket and be able to walk sufficiently for the trials. Those over 263lbs, with multiple amputations, or significant ambulation impairments are excluded.Check my eligibility
What is being tested?
The study tests how different stiffness in commercial prosthetic feet affects stability and fall-related outcomes. It involves up to six visits where participants use both a Prosthetic Foot Emulator (PFE) and actual commercial feet across various surfaces, followed by home use of these feet.See study design
What are the potential side effects?
While not explicitly mentioned, potential side effects may include discomfort or skin issues from different prosthetics, falls during stability testing, and fatigue from participation in walking trials.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered at follow up using the actual prosthetic feet (approximately two hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at follow up using the actual prosthetic feet (approximately two hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biomechanical measures: Medial/Lateral Margin of Stability (MOS)
Performance-based outcomes: Four Square Step Test
Performance-based outcomes: Narrowing Beam Walking Test
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Multiaxial Prosthetic Foot Emulator (PFE)Experimental Treatment1 Intervention
The multiaxial Prosthetic Foot Emulator (PFE) is a customizable robotic prosthetic foot that can mimic commercial feet to predict how prosthesis users will respond to candidate feet. Participants will walk with the PFE using three different modes (emulating three commercial feet) under different walking conditions.
Group II: Commercially available prosthetic feetActive Control1 Intervention
Participants will walk under different walking conditions using three different commercial prosthetic feet.

Find a Location

Who is running the clinical trial?

Seattle Institute for Biomedical and Clinical ResearchLead Sponsor
53 Previous Clinical Trials
13,700 Total Patients Enrolled
VA Puget Sound Health Care SystemFED
65 Previous Clinical Trials
227,713 Total Patients Enrolled
Minneapolis Veterans Affairs Medical CenterFED
73 Previous Clinical Trials
14,980 Total Patients Enrolled

Media Library

Commercially available prosthetic feet Clinical Trial Eligibility Overview. Trial Name: NCT05473065 — N/A
Amputation Research Study Groups: Multiaxial Prosthetic Foot Emulator (PFE), Commercially available prosthetic feet
Amputation Clinical Trial 2023: Commercially available prosthetic feet Highlights & Side Effects. Trial Name: NCT05473065 — N/A
Commercially available prosthetic feet 2023 Treatment Timeline for Medical Study. Trial Name: NCT05473065 — N/A
~17 spots leftby Jul 2024
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