Criteria for Advanced Prosthetic Foot Prescription

March 9, 2026 updated by: Jason Maikos, VA New York Harbor Healthcare System
The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine the appropriate functional outcome tests and measures to support the prescription of a type of Energy Storing and Returning (ESR) non-articulating, articulating or active plantarflexion prosthetic ankle-foot for a Veteran or Service Member with transtibial limb loss. 2) Correlate patient goals and subjective measures with objective data to determine the appropriate prosthetic ankle-foot category that will facilitate the greatest overall function to the user. 3) Develop criteria for the appropriate prescription of non-articulating ESR, articulating ESR, and active plantar flexion ESR ankle-foot units.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • VA New York Harbor Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • DEERS eligible Veteran or Service Member, or civilian with unilateral transtibial amputation
  • Currently using an Energy Storing and Returning prosthetic foot with a well-fitting socket as a primary or back-up prosthesis
  • Achieved a "Modified Independence" score on the Functional Independence Measure (FIM) for the locomotion mobility items
  • Has a minimum clearance of 8 ¾ inches to accommodate all feet

Exclusion Criteria:

  • Has active wounds/ulcers or significant musculoskeletal comorbidities on their intact limb that would impair their ability to participate in all functional outcome measures
  • Has any comorbidity that results in rapid limb volume changes (i.e. end stage renal disease with dialysis),
  • Weighs more than 275 pounds, the maximum product weight load
  • Is unable or unwilling to comply with all research visits
  • Has cognitive deficit(s) or mental health pathology limiting a subject's ability to participate fully in the study
  • Women who are pregnant or plan to become pregnant during study activities. This will be determined by asking the participant if they are pregnant or if they believe that they may be pregnant. This question will only be asked at inclusion, as biomechanical changes will only be impacted if the woman is in the 2nd or 3rd trimester, and will not be impacted if the participant becomes pregnant while in the study.
  • Poorly fitting socket
  • Vision loss that requires use of an assistive device for gait
  • Upper Limb Amputation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: ESR Prosthetic Foot First
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.
Device: ESR Prosthetic Foot First
Subjects will start with an ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.
Active Comparator: Articulating ESR Prosthetic Foot First
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.
Device: Articulating ESR Prosthetic Foot First
Subjects will start with an articulating ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.
Other Names:
  • Odyssey (College Park)
  • Elan (Endolite)
  • MotionFoot (Fillauer)
  • Proflex (Ossur)
  • Echelon (Endolite)
  • Tribute (College Park)
  • Proprio (Ossur)
  • TruStep (College Park)
  • Kinterra (Freedom Innovations)
  • Flex Foot Balance with DP Flexion (Ossur)
  • Raize (Fillauer)
  • Echelon VT (Endolite)
  • Triton Smart Ankle (Otto Bock)
  • Venture (College Park)
  • Kinnex (Freedom Innovations)
Active Comparator: Powered Prosthetic Foot First
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.
Device: Powered Prosthetic Foot First
Subjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR foot and an ESR foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.
Other Names:
  • emPOWER (Otto Bock)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in 6-min walk distance for each prosthetic foot type
Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement.
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in TUG times for each prosthetic foot type
Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The TUG measures the time taken by an individual to stand up from a standard arm chair, walk a distance of 10 feet, turn, walk back to the chair, and sit down.
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in 4SST times for each prosthetic foot type
Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The four-square step test is a higher order complex task assessing dynamic balance.
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in AmpPRO for each prosthetic foot type
Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The AmpPro is a 21-item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation.
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in Stair Assessment Index (SAI) for each prosthetic foot type
Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The SAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a staircase.
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in Hill Assessment Index (HAI) for each prosthetic foot type
Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The HAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a ramp.
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in Gait Evaluation for each prosthetic foot type
Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Biomechanical evaluation of gait.
Once per week, at Week 1, Week 2, and Week 3 after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Prosthetic Evaluation Questionnaire (PEQ) score for each prosthetic foot type
Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The PEQ is a self-report Visual Analog Scale questionnaires for persons with lower limb amputations who use a prosthesis. It consists of 9 validated subscales. They are used to evaluate the prosthesis and life with the prosthesis. Most questions in the PEQ use a visual analog scale format. Each visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line to the point at which the respondent's mark crosses the line. Each line is 100 mm long and is always measured from the left (0-100). The questions are all worded so that a higher number (toward the right) will correspond with a more positive response. Subscale scores are calculated by computing the average (arithmetic mean) of all the questions which make up that particular scale. Only subscales are calculated. A total combined score is not calculated.
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in Short Form (SF)-12 for each prosthetic foot type
Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The SF-12 is a questionnaire used to measure the relationship between physical and mental health functioning and the social determinants of health. It is a self-reported questionnaire, on a rating scale, called a Likert Scale. The participant taking this questionnaire will check one response box per question. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Age-specific mean difference score (difference score) is calculated and is the amount by which a person's score differs from their age group's mean score. By looking at difference scores, it is clear whether a person is more or less healthy than other persons in his or her comparison group.
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Change in OPUS for each prosthetic foot type
Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
OPUS is a set of self-report instruments that assess functional status, quality of life, and satisfaction with devices and services that can be used in an orthotics and prosthetics clinic. The OPUS Health Quality of Life Score is the sum of the scores for the 23 items (0 - 92). The OPUS lower extremity total score is the sum of the scores for the 20 items (0 - 80). OPUS Satisfaction With Device Score is the sum of the scores for items 1-11 (11 - 55). Satisfaction With Services Score is the sum of the scores for items 12-21 (10 - 50). A higher score indicates a better outcome for all measures.
Once per week, at Week 1, Week 2, and Week 3 after enrollment
Final Visit Guided Interview
Time Frame: Administered one time at Final Visit, which will occur 7 weeks after enrollment.
Final Visit questionnaire to evaluate subjective preferences. This is a free response questionnaire, in which the participant can answer in open-ended format.
Administered one time at Final Visit, which will occur 7 weeks after enrollment.
Change in responses to Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) for each prosthetic foot type
Time Frame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
The PEQ-A is a free response 2-question questionnaire, in which the participant is asked whether and how many times they had experienced a fall or near-fall in the previous week using the particular prosthetic foot.
Once per week, at Week 1, Week 2, and Week 3 after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA New York Harbor Healthcare System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Walter Reed National Military Medical Center
VA Puget Sound Health Care System
James A. Haley Veterans Administration Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jason Maikos, PhD, Director, VISN 2 Gait and Motion Analysis Laboratory

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 14, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB #01603
  • CDMRP-OP150095 (Other Grant/Funding Number: CDMRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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