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Prosthetic Foot

Prosthetic Foot Prescription for Lower Limb Amputation

N/A
Recruiting
Led By Jason Maikos, PhD
Research Sponsored by VA New York Harbor Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DEERS eligible Veteran or Service Member, or civilian with unilateral transtibial amputation
Achieved a 'Modified Independence' score on the Functional Independence Measure (FIM) for the locomotion mobility items
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once per week, at week 1, week 2, and week 3 after enrollment
Awards & highlights

Study Summary

This trial is looking at what types of prosthetic feet work best for people with transtibial limb loss.

Who is the study for?
This trial is for Veterans, Service Members, or civilians with one lower leg amputated who can move around independently and have a well-fitting prosthetic foot. They must be able to attend all research visits and not have vision loss that affects walking, rapid limb volume changes due to conditions like kidney disease on dialysis, active wounds on the remaining leg, cognitive issues affecting study participation, an upper limb amputation or weigh over 275 pounds.Check my eligibility
What is being tested?
The study aims to establish criteria for prescribing different types of prosthetic feet: non-articulating ESR (Energy Storing and Returning), articulating ESR, and powered prosthetic feet. It will test which type best enhances overall function by correlating patient goals with objective data from functional outcome tests.See study design
What are the potential side effects?
While this trial does not involve medication with typical side effects, participants may experience discomfort or challenges while adjusting to different types of prosthetic feet during the testing of their functionality.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a veteran, service member, or civilian with one below-knee amputation.
Select...
I can move around with little to no help.
Select...
I use a specific type of prosthetic foot that stores and returns energy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once per week, at week 1, week 2, and week 3 after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and once per week, at week 1, week 2, and week 3 after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 4SST times for each prosthetic foot type
Change in 6-min walk distance for each prosthetic foot type
Change in AmpPRO for each prosthetic foot type
+4 more
Secondary outcome measures
Change in OPUS for each prosthetic foot type
Change in Prosthetic Evaluation Questionnaire (PEQ) score for each prosthetic foot type
Foot
+2 more

Trial Design

3Treatment groups
Active Control
Group I: Articulating ESR Prosthetic Foot FirstActive Control1 Intervention
Subjects will start with an Articulating ESR prosthetic foot first for 1 week, then will complete an additional week with the ESR prosthetic foot, and a powered prosthetic foot for 1 week.The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities.
Group II: Powered Prosthetic Foot FirstActive Control1 Intervention
Subjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot and an ESR prosthetic foot for 1 week. The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities.
Group III: ESR Prosthetic Foot FirstActive Control1 Intervention
Subject will start with an energy storing and returning (ESR) prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot, and a powered prosthetic foot for 1 week. During the final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.

Find a Location

Who is running the clinical trial?

VA New York Harbor Healthcare SystemLead Sponsor
24 Previous Clinical Trials
17,575 Total Patients Enrolled
1 Trials studying Prosthesis User
30 Patients Enrolled for Prosthesis User
Walter Reed National Military Medical CenterFED
136 Previous Clinical Trials
37,235 Total Patients Enrolled
1 Trials studying Prosthesis User
30 Patients Enrolled for Prosthesis User
James A. Haley Veterans Administration HospitalFED
20 Previous Clinical Trials
16,287 Total Patients Enrolled

Media Library

Articulating ESR Prosthetic Foot (Prosthetic Foot) Clinical Trial Eligibility Overview. Trial Name: NCT03505983 — N/A
Prosthesis User Research Study Groups: Articulating ESR Prosthetic Foot First, Powered Prosthetic Foot First, ESR Prosthetic Foot First
Prosthesis User Clinical Trial 2023: Articulating ESR Prosthetic Foot Highlights & Side Effects. Trial Name: NCT03505983 — N/A
Articulating ESR Prosthetic Foot (Prosthetic Foot) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03505983 — N/A

Frequently Asked Questions

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

What is the core intent of this experiment?

"This medical trial will measure the efficacy of prosthetic feet by assessing participants' Hill Assessment Index (HAI) once a week for three weeks after enrollment. Secondary outcomes include changes in responses to Prosthetic Evaluation Questionnaire-Addendum (PEQ-A), OPUS, and PEQ scores. These assessments use various methods such as Visual Analog Scale questionnaires and self-reported surveys to gauge participants' quality of life, satisfaction with devices/services, and functional status."

Answered by AI

To what extent is this research project involving participants?

"Indeed, clinicaltrials.gov reveals that this research project is presently searching for 120 individuals across a single location. It was initially posted on August 1st 2017 and its information has been updated as recently as October 17th 2022."

Answered by AI

Are there any opportunities for individuals to partake in this current research endeavor?

"Affirmative. Clinicaltrials.gov verifies that this medical experiment, which was first posted on August 1st 2017 is still recruiting study participants. A total of 120 volunteers are sought from one location to take part in the trial."

Answered by AI
~13 spots leftby Mar 2025