Maikos Jason T, Hendershot Brad D, Pruziner Alison L, Hyre Michael J, Chomack John M, Phillips Samuel L, Heckman Jeffrey T, Sidiropoulos Alexis N, Dearth Christopher L, Nelson Leif M
Veterans Affairs New York Harbor Healthcare System, New York, NY, United States.
Walter Reed National Military Medical Center, Bethesda, MD, United States.
JMIR Res Protoc. 2023 Apr 4;12:e45612. doi: 10.2196/45612.
The prescription of prosthetic ankle-foot devices is often based on the professional judgment of the limb loss care team or limited evidentiary research. Current prosthetic research efforts have focused on the design and development of prosthetic devices rather than on understanding which devices are the most appropriate to prescribe. This investigation will evaluate biomechanical, functional, and subjective outcome measures to help determine the optimal prescription parameters of prosthetic ankle-foot devices.
This study aims to develop evidence-based guidelines for limb loss care teams for the appropriate prescription of commercially available prosthetic ankle-foot devices to improve function and satisfaction.
This investigation will be a multisite, randomized, crossover clinical trial targeting the enrollment of 100 participants. Participants will use 3 different types of prosthetic devices (energy storing and returning, articulating, and powered) in random order. Participants will be fitted and trained with each device and then separately use each device for a 1-week acclimation period. Following each 1-week acclimation period, participants will be evaluated using several functional measures and subjective surveys. A random subset of participants (30/100, 30%) will also undergo full-body gait analysis, following each 1-week acclimation period, to collect biomechanical data during level ground and incline and decline walking. After all individual device evaluations, participants will be given all 3 prostheses concurrently for 4 weeks of home and community use to capture user preference. Activity monitoring and a guided interview will be used to determine overall user preference.
The study was funded in August 2017, and data collection began in 2018. Data collection is expected to be completed before July 2023. Initial dissemination of results is expected to occur in the winter of 2023.
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.
ClinicalTrials.gov NCT03505983; https://clinicaltrials.gov/ct2/show/NCT03505983.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45612.
假肢踝足装置的处方通常基于肢体缺失护理团队的专业判断或有限的实证研究。目前的假肢研究工作主要集中在假肢装置的设计和开发上，而不是了解哪种装置最适合开具处方。本研究将评估生物力学、功能和主观结果指标，以帮助确定假肢踝足装置的最佳处方参数。
本研究旨在为肢体缺失护理团队制定基于证据的指南，以便为市售假肢踝足装置开具合适的处方，从而改善功能和满意度。
本研究将是一项多中心、随机、交叉临床试验，目标招募100名参与者。参与者将按随机顺序使用3种不同类型的假肢装置（储能回能型、关节型和动力型）。将为参与者安装每种装置并进行培训，然后让他们分别使用每种装置进行为期1周的适应期。在每个为期1周的适应期之后，将使用多种功能指标和主观调查问卷对参与者进行评估。在每个为期1周的适应期之后，还将对随机抽取的一部分参与者（30/100，30%）进行全身步态分析，以收集在平路、上坡和下坡行走时的生物力学数据。在完成所有单个装置评估之后，将同时给予参与者所有3种假肢，供其在家中和社区使用4周，以了解用户偏好。将使用活动监测和引导式访谈来确定总体用户偏好。
该研究于2017年8月获得资助，数据收集于2018年开始。预计数据收集将在2023年7月之前完成。预计将于2023年冬季初步公布研究结果。
通过确定对假肢踝足装置差异敏感的生物力学功能和主观结果，可以建立一个证据基准，以指导有效的假肢处方。
ClinicalTrials.gov NCT03505983；https://clinicaltrials.gov/ct2/show/NCT03505983。
国际注册报告识别码（IRRID）：DERR1-10.2196/45612。
