PDF(Pubmed)
Abstract：
BACKGROUND: Ankle-foot orthoses (AFOs) are commonly used to overcome mobility limitations related to lower limb musculoskeletal injury. Despite a multitude of AFOs to choose from, there is scant evidence to guide AFO prescription and limited opportunities for AFO users to provide experiential input during the process. To address these limitations in the current prescription process, this study evaluates a novel, user-centered and personalized \'test-drive\' strategy using a robotic exoskeleton (\'AFO emulator\') to emulate commercial AFO mechanical properties (i.e., stiffness). The study will determine if brief, in-lab trials (with emulated or actual AFOs) can predict longer term preference, satisfaction, and mobility outcomes after community trials (with the actual AFOs). Secondarily, it will compare the in-lab experience of walking between actual vs. emulated AFOs.
METHODS: In this participant-blinded, randomized crossover study we will recruit up to fifty-eight individuals with lower limb musculoskeletal injuries who currently use an AFO. Participants will walk on a treadmill with three actual AFOs and corresponding emulated AFOs for the \"in-lab\" assessments. For the community trial assessment, participants will wear each of the actual AFOs for a two-week period during activities of daily living. Performance-based and user-reported measures of preference and mobility will be compared between short- and long-term trials (i.e., in-lab vs. two-week community trials), and between in-lab trials (emulated vs. actual AFOs).
BACKGROUND: The study was prospectively registered at www.clininicaltrials.gov (Clinical Trials Study ID: NCT06113159). Date: November 1st 2023. https://classic.clinicaltrials.gov/ct2/show/NCT06113159.
METHODS: In this participant-blinded, randomized crossover study we will recruit up to fifty-eight individuals with lower limb musculoskeletal injuries who currently use an AFO. Participants will walk on a treadmill with three actual AFOs and corresponding emulated AFOs for the \"in-lab\" assessments. For the community trial assessment, participants will wear each of the actual AFOs for a two-week period during activities of daily living. Performance-based and user-reported measures of preference and mobility will be compared between short- and long-term trials (i.e., in-lab vs. two-week community trials), and between in-lab trials (emulated vs. actual AFOs).
BACKGROUND: The study was prospectively registered at www.clininicaltrials.gov (Clinical Trials Study ID: NCT06113159). Date: November 1st 2023. https://classic.clinicaltrials.gov/ct2/show/NCT06113159.
摘要：
背景：踝足矫形器（AFO）通常用于克服与下肢肌肉骨骼损伤相关的活动限制。尽管有许多AFO可供选择，很少有证据指导AFO处方，并且AFO用户在此过程中提供经验输入的机会有限。为了解决当前处方过程中的这些限制，这项研究评估了一部小说，以用户为中心和个性化的“测试驱动”策略，使用机器人外骨骼(“AFO模拟器”)来模拟商业AFO机械特性(即，刚度)。这项研究将确定是否简短，实验室试验(使用模拟或实际的AFO)可以预测更长期的偏好，满意,和社区试验后的流动性结果(与实际的AFO)。其次，它将比较实际与实际之间的实验室步行经验模拟AFO。
方法：在这个参与者盲目的，随机交叉研究我们将招募多达58名目前使用AFO的下肢肌肉骨骼损伤患者。参与者将在跑步机上行走，其中包含三个实际的AFO和相应的仿真AFO进行“实验室内”评估。对于社区试验评估，参与者将在日常生活活动中佩戴每个实际的AFO，为期两周。基于性能和用户报告的偏好和流动性衡量标准将在短期和长期试验之间进行比较(即，实验室内vs.为期两周的社区试验)，在实验室试验之间(模拟与实际的AFO）。
背景：该研究在www上进行了前瞻性注册。clininicaltrials.gov（临床试验研究编号：NCT06113159）。日期：2023年11月1日。https://经典。clinicaltrials.gov/ct2/show/NCT06113159.
方法：在这个参与者盲目的，随机交叉研究我们将招募多达58名目前使用AFO的下肢肌肉骨骼损伤患者。参与者将在跑步机上行走，其中包含三个实际的AFO和相应的仿真AFO进行“实验室内”评估。对于社区试验评估，参与者将在日常生活活动中佩戴每个实际的AFO，为期两周。基于性能和用户报告的偏好和流动性衡量标准将在短期和长期试验之间进行比较(即，实验室内vs.为期两周的社区试验)，在实验室试验之间(模拟与实际的AFO）。
背景：该研究在www上进行了前瞻性注册。clininicaltrials.gov（临床试验研究编号：NCT06113159）。日期：2023年11月1日。https://经典。clinicaltrials.gov/ct2/show/NCT06113159.
