Criteria for Advanced Prosthetic Foot Prescription
United States91 participantsStarted 2018-03-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Amputati…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in 6-min walk distance for each prosthetic foot type
Timeframe: Once per week, at Week 1, Week 2, and Week 3 after enrollment
2
Change in TUG times for each prosthetic foot type
Timeframe: Once per week, at Week 1, Week 2, and Week 3 after enrollment
3
Change in 4SST times for each prosthetic foot type
Timeframe: Once per week, at Week 1, Week 2, and Week 3 after enrollment
4
Change in AmpPRO for each prosthetic foot type
Timeframe: Once per week, at Week 1, Week 2, and Week 3 after enrollment
5
Change in Stair Assessment Index (SAI) for each prosthetic foot type
Timeframe: Once per week, at Week 1, Week 2, and Week 3 after enrollment
6
Change in Hill Assessment Index (HAI) for each prosthetic foot type
Timeframe: Once per week, at Week 1, Week 2, and Week 3 after enrollment
7
Change in Gait Evaluation for each prosthetic foot type