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.
Keywords: Assistive wearable robots; Orthosis; Spinal cord injury; Three-dimensional printing.