Discussion
stroke, orthosis, chronic deficits
STROKE
The integration of 3D scanning and 3D printing technologies into orthosis manufacturing has paved the way for the creation of custom, form-fitting orthoses that meet the user's anatomical and functional needs. Studies indicate that the comfort and effectiveness of 3D-printed orthoses surpass those of conventional orthoses [The current NuroSleeve is the result of several iterations based on the feedback received from study participants and OTs as part of the ongoing clinical trial. The primary design changes implemented thus far include: (1) the 3D model was altered by removing material at the wrist to avoid contact with bony prominences; (2) the thumb and cuff pieces were separated into two distinct pieces, allowing the user to more easily don and doff the splint; and (3) the joystick controller has been mounted onto the splint, making it more convenient for the user to control the device with their unimpaired hand. We found this to be extremely helpful for individuals who rely on their unaffected hand to support and move their impaired arm; since the unimpaired hand typically provides support in the proximity of the contralateral forearm, placing the joystick in this area allows for quick and easy access to it. Although the NuroSleeve can be controlled by EMG signals, which are highly correlated with voluntary UE movements, based on previous studies [Although the clinical results presented are from a small cohort of participants in a feasibility study, it should be noted that there is no plausible physiologic or physical process by which random chance would account for the functional improvements seen in these participants; all of them had been living with chronic deficits for two or more years following a stroke and had already exhausted standard rehabilitation therapy. Most importantly, each served as their own control and compared function with and without the device, demonstrating that the benefits were due to the device and not to a non-specific mass practice effect. The functional improvements observed merit a prospective, randomized, controlled trial with an adequate sample size to be able to differentiate the relative contributions of traditional rehabilitation therapy alone, traditional rehabilitation with the NuroSleeve, and abbreviated rehabilitation with the NuroSleeve. In addition to the promising preliminary findings, this trial demonstrates a successful model for the future of UE rehabilitation methods an interdisciplinary approach where a team comprised of neurology, engineering, software development, industrial design, and occupational therapy professionals collaborates to design and create a customizable, durable, and genuinely functional assistive device.