Criteria for Advanced Prosthetic Foot Prescription

Summary

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.

Conditions

• Prosthesis User
• Amputation; Traumatic, Limb, Lower

Interventions

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.

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.

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.

Sponsors & Collaborators

• Walter Reed National Military Medical Center

  collaborator FED

• James A. Haley Veterans Administration Hospital

  collaborator FED

• VA Puget Sound Health Care System

  collaborator FED

• VA New York Harbor Healthcare System

  lead FED

Principal Investigators

• Jason Maikos, PhD · Director, VISN 2 Gait and Motion Analysis Laboratory

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-03-07

Primary Completion

2023-09-14

Completion

2026-09-01

Countries

• United States

Study Locations