Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 9, 2023
Date Accepted: Jan 31, 2023
Criteria for Advanced Prosthetic Foot Prescription: Rationale, Design, and Protocol for a Multi-Site, Randomized Clinical Trial
ABSTRACT
Background:
Prescription of prosthetic ankle-foot devices is often based on the professional judgment of the amputation care team or limited evidentiary research. Current prosthetic research efforts have focused on the design and development of prosthetic devices rather than understanding which devices are most appropriate to prescribe. This investigation will evaluate biomechanical, functional, and subjective outcome measures to help determine optimal prescription parameters of prosthetic ankle-foot devices.
Objective:
To develop evidence-based guidelines for limb loss care teams for the appropriate prescription of commercially available prosthetic foot-ankle devices in order to improve function and satisfaction.
Methods:
This investigation will be a multi-site, randomized, cross-over clinical trial targeting enrollment of 100 participants. Participants utilize three different types of prosthetic devices (energy storing and returning, articulating, and powered) in random order. Participants will be fit and trained with each device and then separately utilize each device for a one-week acclimation period. Following each one-week acclimation, participants will be evaluated with several functional measures and subjective surveys. A random subset of participants (n=30) will also undergo full-body gait analysis, following each one-week acclimation period, to collect biomechanical data during level-ground and incline/decline walking. After all individual device evaluations, participants will be given all three prostheses concurrently for four weeks of home and community use to capture user preference. Activity monitoring and a guided interview will be used to determine overall user preference.
Results:
The study was funded in August of 2017 with data collection beginning in 2018. Data collection is expected to conclude prior to July 2023. Initial dissemination of results is expected in the winter of 2023.
Conclusions:
By identifying biomechanical, functional, and subjective outcomes that are sensitive to differences in prosthetic ankle-foot devices, a benchmark of evidence can be developed to guide effective prosthetic prescription. Clinical Trial: ClinicalTrials.gov Identifier: NCT03505983
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