Silva Rui, Morouço Pedro, Lains Jorge, Amorim Paula, Alves Nuno, Veloso António Prieto
Centre for Rapid and Sustainable Product Development, Polytechnic University of Leiria, Marinha Grande, Portugal.
CIPER, Faculdade de Motricidade Humana, Lisboa, Portugal.
JMIR Res Protoc. 2024 Apr 2;13:e52365. doi: 10.2196/52365.
Ankle-foot orthoses (AFOs) are vital in gait rehabilitation for patients with stroke. However, many conventional AFO designs may not offer the required precision for optimized patient outcomes. With the advent of 3D scanning and printing technology, there is potential for more individualized AFO solutions, aiming to enhance the rehabilitative process.
This nonrandomized trial seeks to introduce and validate a novel system for AFO design tailored to patients with stroke. By leveraging the capabilities of 3D scanning and bespoke software solutions, the aim is to produce orthoses that might surpass conventional designs in terms of biomechanical effectiveness and patient satisfaction.
A distinctive 3D scanner, complemented by specialized software, will be developed to accurately capture the biomechanical data of leg movements during gait in patients with stroke. The acquired data will subsequently guide the creation of patient-specific AFO designs. These personalized orthoses will be provided to participants, and their efficacy will be compared with traditional AFO models. The qualitative dimensions of this experience will be evaluated using the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) assessment tool. Feedback from health care professionals and the participants will be considered throughout the trial to ensure a rounded understanding of the system's implications.
Spatial-temporal parameters will be statistically compared using paired t tests to determine significant differences between walking with the personalized orthosis, the existing orthosis, and barefoot conditions. Significant differences will be identified based on P values, with P<.05 indicating statistical significance. The Statistical Parametric Mapping method will be applied to graphically compare kinematic and kinetic data across the entire gait cycle. QUEST responses will undergo statistical analysis to evaluate patient satisfaction, with scores ranging from 1 (not satisfied) to 5 (very satisfied). Satisfaction scores will be presented as mean and SD values. Significant variations in satisfaction levels between the personalized and existing orthosis will be assessed using a Wilcoxon signed rank test. The anticipation is that the AFOs crafted through this innovative system will either match or outperform existing orthoses in use, with higher patient satisfaction rates.
Embracing the synergy of technology and biomechanics may hold the key to revolutionizing orthotic design, with the potential to set new standards in patient-centered orthotic solutions. However, as with all innovations, a balanced approach, considering both the technological possibilities and individual patient needs, will be paramount to achieving optimal outcomes.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/52365.
踝足矫形器（AFO）在中风患者的步态康复中至关重要。然而，许多传统的AFO设计可能无法提供实现患者最佳康复效果所需的精准度。随着3D扫描和打印技术的出现，有可能提供更个性化的AFO解决方案，以改善康复进程。
这项非随机试验旨在引入并验证一种专门为中风患者设计的新型AFO系统。通过利用3D扫描和定制软件解决方案的功能，目标是生产出在生物力学有效性和患者满意度方面可能超越传统设计的矫形器。
将开发一种独特的3D扫描仪，并辅以专门软件，以准确捕捉中风患者步态期间腿部运动的生物力学数据。所获取的数据随后将指导制作针对患者的AFO设计。这些个性化的矫形器将提供给参与者，并将其效果与传统AFO模型进行比较。将使用魁北克辅助技术满意度用户评估（QUEST）工具评估这一体验的定性维度。在整个试验过程中，将考虑医疗保健专业人员和参与者的反馈，以全面了解该系统的影响。
将使用配对t检验对时空参数进行统计学比较，以确定在穿着个性化矫形器、现有矫形器和赤足行走条件下的显著差异。将根据P值确定显著差异，P<0.05表示具有统计学意义。将应用统计参数映射方法以图形方式比较整个步态周期的运动学和动力学数据。QUEST问卷的回答将进行统计分析，以评估患者满意度，分数范围为1（不满意）至5（非常满意）。满意度得分将以均值和标准差表示。将使用Wilcoxon符号秩检验评估个性化矫形器与现有矫形器之间满意度水平的显著差异。预期通过这种创新系统制作的AFO将与现用的矫形器相当或更优，患者满意度更高。
利用技术与生物力学的协同作用可能是彻底改变矫形器设计的关键，有可能为以患者为中心的矫形器解决方案设定新标准。然而，与所有创新一样，在考虑技术可能性和个体患者需求的同时采取平衡的方法对于实现最佳效果至关重要。
国际注册报告识别号（IRRID）：PRR1-10.2196/52365。
