Methods
orthosis
The NuroSleeve comprises six main components: a custom 3D-printed splint, an external FES unit, a main control unit (MCU), a clinical software suite for configuration, a rechargeable battery and a series of input sensors, as shown in Fig. The NuroSleeve consists of the main control unit (center), which accepts different input control signals (left) to control one or more end effectors (right). Implementations are customized for each patient by the occupational therapist using the clinical configuration softwareIt is important to emphasize that the NuroSleeve device is user-specific and is personalized with the help of an occupational therapist (OT) using the clinical configuration software. The OT can exploit rehabilitation therapy principles to help identify the optimal combination of sensor inputs and effectors and the optimal placement of each (including FES electrodes) based on the individual’s unique abilities, needs, and functional goals. The OT also elicits feedback from the user about what configuration of the device and control mechanism may be more intuitive or easier to use. This information is relayed to the design team, which then designs and implements the solution for the participant, and/or uses the feedback to inform improvements to the overall system design. Via wireless Bluetooth connectivity, the clinical software suite allows for device setup, configuration, usage monitoring, real-time data collection and visualization.The NuroSleeve splint is customized for each individual using 3D scanning and printing technologies. Each splint is built to accommodate the unique anatomy and impairment of the user to maximize comfort, efficacy, and fit. We refer to this customization process as the “digital orthotist” process, as it combines modern industrial design techniques with occupational therapy and orthotics know-how. The process starts with a 3D scan of the user’s impaired hand and forearm, which is then used to build a custom computer-aided design (CAD) model of the splint. The model may be fine-tuned to suit the user as necessary, and then it is 3D printed. The combination of 3D scanning and printing technologies together with user feedback integration has facilitated our development of an orthosis that is lightweight, aesthetically pleasing, and form-fitting in key locations while form-adjusted in others to avoid pressure points and bony prominences [