Clinical trial NCT03505983: Criteria for Advanced Prosthetic Foot Prescription
Official title: Criteria for Advanced Prosthetic Foot Prescription
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prosthesis User
Amputation; Traumatic, Limb, Lower
Keywords: Prosthetic Limb Design
Prosthesis Fitting
Lead sponsor: VA New York Harbor Healthcare System
Sponsor class: FED
Collaborators: name: Walter Reed National Military Medical Center
name: James A. Haley Veterans Administration Hospital
name: VA Puget Sound Health Care System
First posted: 2018-04-23
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: Change in TUG times for each prosthetic foot type
timeFrame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
measure: Change in 4SST times for each prosthetic foot type
timeFrame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
measure: Change in AmpPRO for each prosthetic foot type
timeFrame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
measure: 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
measure: 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
measure: Change in Gait Evaluation for each prosthetic foot type
timeFrame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Secondary outcomes:
measure: Change in Prosthetic Evaluation Questionnaire (PEQ) score for each prosthetic foot type
timeFrame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
measure: Change in Short Form (SF)-12 for each prosthetic foot type
timeFrame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
measure: Change in OPUS for each prosthetic foot type
timeFrame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
measure: Final Visit Guided Interview
timeFrame: Administered one time at Final Visit, which will occur 7 weeks after enrollment.
measure: Change in responses to Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) for each prosthetic foot type
timeFrame: Once per week, at Week 1, Week 2, and Week 3 after enrollment
Other outcomes:
Locations:
city: New York
country: United States
facility: VA New York Harbor Healthcare System
state: New York
Study officials:
affiliation: Director, VISN 2 Gait and Motion Analysis Laboratory
name: Jason Maikos, PhD
role: PRINCIPAL_INVESTIGATOR
References: