Clinical trial
orthosis
In addition to the extensive non-clinical bench electrical and mechanical testing, the NuroSleeve has been evaluated in a clinical setting by various stakeholders, including users, therapists, caregivers, and physicians. Continuous integration of stakeholder feedback is crucial to the development of a device with practical utility. The NuroSleeve is currently being evaluated in a clinical trial (NCT04798378), approved by the Thomas Jefferson University Institutional Review Board (IRB). Consenting and enrolled participants complete an 8-week rehabilitation program that incorporates the device into occupational therapy sessions and ADLs at their homes.In brief, the trial consists of an initial (pre-intervention) clinical outcome assessment session, which establishes a baseline of each participant’s UE functional ability. The Canadian Occupational Performance Measure (COPM) [The elements of the NuroSleeve system used during sessions vary between participants and between sessions. Personalized control strategies are selected independently based on their preferences and physical abilities. During therapy sessions, the participant and therapist can use the orthosis or FES effector independently or simultaneously. While these sessions are ongoing, if and when the participant demonstrates the ability to use the NuroSleeve independently, they take the NuroSleeve home and start to use it during daily activities. After the 8-week intervention period, the standardized outcome assessments are repeated, with and without the device being worn.Controlling the orthosis could be achieved by joystick or IMU; control of the FES was achieved using an IMU (or a second IMU if one is being used for the motor at the same time). While EMG control was available to all participants, it has not been widely adopted because, in the early sessions with the first participant, who had extensive experience with EMG-controlled devices, it did not prove to be a reliable or consistent control method [