Criteria for Advanced Prosthetic Foot Prescription

VA New York Harbor Healthcare System

Status: Active, not recruiting

Conditions: Amputation; Traumatic, Limb, Lower; Prosthesis User

Treatments: Device: Articulating ESR Prosthetic Foot First; Device: ESR Prosthetic Foot First; Device: Powered Prosthetic Foot First

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03505983

CDMRP-OP150095 (Other Grant/Funding Number)

IRB #01603

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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91 participants in 3 patient groups

Articulating ESR Prosthetic Foot First

Active Comparator group

Description:

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.

Treatment:

Device: Articulating ESR Prosthetic Foot First

Powered Prosthetic Foot First

Active Comparator group

Description:

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.

Treatment:

Device: Powered Prosthetic Foot First

ESR Prosthetic Foot First

Active Comparator group

Description:

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.

Treatment:

Device: ESR Prosthetic Foot First