Criteria for Advanced Prosthetic Foot Prescription
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/29/2018 |
| Start Date: | August 1, 2017 |
| End Date: | September 30, 2021 |
| Contact: | Michael Hyre, MS |
| Email: | michael.hyre@va.gov |
| Phone: | 212-951-3339 |
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.
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.
Inclusion Criteria:
- DEERS eligible Veteran or Service Member 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 "No Helper" score of 5, 6, or 7 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. 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
- Potential participants with knee flexion contracture > 5 degrees
- Vision loss that requires use of an assistive device for gait
- Upper Limb Amputation
We found this trial at
1
site
New York, New York 10010
Principal Investigator: Jason Maikos, PhD
Phone: 212-951-3339
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