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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ administered at baseline with the commercial feet (approximately 2 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~administered at baseline with the commercial feet (approximately 2 hours)
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 moreTrial 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
52 Previous Clinical Trials
13,300 Total Patients Enrolled
VA Puget Sound Health Care SystemFED
65 Previous Clinical Trials
227,683 Total Patients Enrolled
Minneapolis Veterans Affairs Medical CenterFED
72 Previous Clinical Trials
14,820 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I be a suitable candidate for this experimental procedure?
"A total of 100 persons aged between 18 and 89, who already possess an amputation are being admitted to this study. Additional requirements include having a unilateral transtibial below-knee amputation with at least 6 months of prosthetic limb usage experience, be able to comfortably fit in the socket, have removable foot attachment for use with experimental feet & walk sufficiently using their artificial limbs for participation purposes."
Answered by AI
Does the eligibility criteria for this clinical trial extend beyond adults aged 35 and under?
"Those who are 18 years or older but younger than 89 have the opportunity to join this experiment."
Answered by AI
Are there still openings to participate in this scientific experiment?
"Data hosted on clinicaltrials.gov affirms that this medical study, which was initially posted in January of 2023, is not currently enrolling participants. However, at present there are 66 other trials actively searching for test subjects."
Answered by AI
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