BACKGROUND Spinal cord injury (SCI) is a severe medical condition affecting the hand and locomotor function. New medical technologies, including various wearable devices, as well as rehabilitation treatments are being developed to enhance hand function in patients with SCI. As three-dimensional (3D) printing has the advantage of being able to produce low-cost personalized devices, there is a growing appeal to apply this technology to rehabilitation equipment in conjunction with scientific advances. In this study, we proposed a novel 3D-printed hand orthosis that is controlled by electromyography (EMG) signals. The orthosis was designed to aid the grasping function for patients with cervical SCI. We applied this hand exoskeleton system to individuals with tetraplegia due to SCI and validated its effectiveness. METHODS The 3D architecture of the device was designed using computer-aided design software and printed with a polylactic acid filament. The dynamic hand orthosis enhanced the tenodesis grip to provide sufficient grasping function. The root mean square of the EMG signal was used as the input for controlling the device. Ten subjects with hand weakness due to chronic cervical SCI were enrolled in this study, and their hand function was assessed before and after wearing the orthosis. The Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) was used as the primary outcome measure. Furthermore, improvements in functional independence in daily living and device usability were evaluated. RESULTS The newly developed orthosis improved hand function of subjects, as determined using the TRI-HFT (p < 0.05). Furthermore, participants obtained immediate functionality on eating after wearing the orthosis. Moreover, most participants were satisfied with the device as determined by the usability test. There were no side effects associated with the experiment. CONCLUSIONS The 3D-printed myoelectric hand orthosis was intuitive, easy to use, and showed positive effects in its ability to handle objects encountered in daily life. This study proved that combining simple EMG-based control strategies and 3D printing techniques was feasible and promising in rehabilitation engineering. TRIAL REGISTRATION Clinical Research Information Service (CRiS), Republic of Korea. KCT0003995. Registered 2 May 2019 - Retrospectively registered.

中文翻译：

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为脊髓损伤患者开发3D打印肌电手矫形器。

背景技术脊髓损伤(SCI)是一种影响手部和运动功能的严重疾病。人们正在开发新的医疗技术，包括各种可穿戴设备以及康复治疗，以增强 SCI 患者的手部功能。由于三维（3D）打印具有能够生产低成本个性化设备的优势，因此越来越多的人希望将这项技术与科学进步结合起来应用于康复设备。在这项研究中，我们提出了一种由肌电图 (EMG) 信号控制的新型 3D 打印手部矫形器。该矫形器旨在帮助颈椎 SCI 患者提高抓握功能。我们将这种手部外骨骼系统应用于因 SCI 导致的四肢瘫痪的个体，并验证了其有效性。方法 该设备的 3D 架构是使用计算机辅助设计软件设计的，并用聚乳酸长丝打印。动态手矫形器增强了肌腱固定术的握力，以提供足够的抓握功能。EMG 信号的均方根用作控制设备的输入。本研究纳入了 10 名因慢性颈椎 SCI 导致手部无力的受试者，在佩戴矫形器之前和之后评估了他们的手部功能。多伦多康复研究所手功能测试 (TRI-HFT) 被用作主要结果测量。此外，还评估了日常生活功能独立性和设备可用性的改善。结果 根据 TRI-HFT 的测定，新开发的矫形器改善了受试者的手部功能（p < 0.05）。此外，参与者在佩戴矫形器后立即获得了进食功能。此外，根据可用性测试，大多数参与者对该设备感到满意。没有与实验相关的副作用。结论 3D 打印肌电手矫形器直观、易于使用，并且在处理日常生活中遇到的物体的能力方面显示出积极的效果。这项研究证明，将简单的基于 EMG 的控制策略与 3D 打印技术相结合在康复工程中是可行且有前景的。试验注册 韩国临床研究信息服务 (CRiS)。KCT0003995。2019 年 5 月 2 日注册 - 追溯注册。