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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 during follow up testing with the commercial feet (approximately 2 hours)
Awards & highlights
No Placebo-Only Group
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ administered at follow up using the actual prosthetic feet (approximately two hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered at follow up using the actual prosthetic feet (approximately two hours)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Biomechanical measures: Medial/Lateral Margin of Stability (MOS)
Performance-based outcomes: Four Square Step Test
Performance-based outcomes: Narrowing Beam Walking Test
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Seattle Institute for Biomedical and Clinical ResearchLead Sponsor
54 Previous Clinical Trials
13,601 Total Patients Enrolled
VA Puget Sound Health Care SystemFED
65 Previous Clinical Trials
224,684 Total Patients Enrolled
Minneapolis Veterans Affairs Medical CenterFED
76 Previous Clinical Trials
354,685 Total Patients Enrolled
University of ChicagoOTHER
1,062 Previous Clinical Trials
840,034 Total Patients Enrolled
David C Morgenroth, MDPrincipal InvestigatorVA Puget Sound Health Care System
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My weight is over 263lbs.I am able to understand and communicate my consent to participate.I am unable to make medical decisions for myself.I have one leg amputated below the knee.My prosthetic socket fits comfortably.I have an amputation that may affect my participation in the study.I have been using a prosthetic limb for walking for over six months.I do not have any health issues that majorly affect my ability to walk.I can walk with a prosthetic limb well enough to join in walking trials.My prosthetic foot can be detached and replaced.I cannot walk well enough to complete the study tasks without great difficulty.
Research Study Groups:
This trial has the following groups:- Group 1: Multiaxial Prosthetic Foot Emulator (PFE)
- Group 2: Commercially available prosthetic feet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.