Clinical trial outcomes
orthosis, hemiparesis from chronic stroke
At the time of this report, five individuals with hemiparesis from chronic stroke had completed participation in the NuroSleeve clinical trial. The trial intervention comprises three one-hour occupational therapy sessions per week and daily home use of the NuroSleeve for a total of 8 weeks. The primary clinical outcome measure is the COPM [Performance and satisfaction scores on the COPM for NS1, NS3, NS4, NS6, and NS7 (Per. = Performance, Sat. = Satisfaction). COPM was performed three times, once at the beginning of the trial, and twice at the end of the trial with and without the device. The bars represent COPM scores. The black bars are for the pre-trial scores (baseline), the pink bars are for the post-trial scores without the device, and the blue bars are for the post-trial scores with the deviceThe OTs were able to set up and save individual settings for each participant on the NuroSleeve, and the participants were able to select their preferred control and activation methods using the push-button on the MCU in order to readily use the orthoses. Based on 3D scans of their hands and forearms, all five participants received customized 3D-printed orthoses and used the orthosis with the joystick as the main controller because it was found to be the simplest and most reliable to use during activities. Furthermore, two participants (NS6 and NS7) used the FES effector in addition to the orthosis, and used IMU control in addition to the joystick. All participants used the joystick and/or IMUs to control NuroSleeve in their homes without requiring additional calibration or adjustments. All participants learned how to don and doff the NuroSleeve on their own and were able to use the device at home. Most importantly, all but one participant improved on the primary outcome measure and provided valuable feedback to guide future design improvements. All participants found the device to be lightweight, portable, authentic, comfortable, easy to don and doff and form-fitting, which made them willing to use it in a social setting.The clinical findings shown in Fig. 