NCT03505983

Criteria for Advanced Prosthetic Foot Prescription

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: VA New York Harbor Healthcare System · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-03-07
• Primary completion: 2023-09-14
• Completion: 2026-09-01
• First posted: 2018-04-23
• Last updated: 2026-03-10

Locations

1 site across 1 country: United States