The NuroSleeve, A User-Centered 3D Printed Orthosis and Functional Electrical Stimulation System for Individuals with Upper Extremity Impairment

Abstract Background: Active upper extremity (UE) assistive devices have the potential to restore independent functional movement in individuals with UE impairment due to neuromuscular diseases or injury-induced chronic weakness. Academically fabricated UE assistive devices are not usually optimized for Activities of Daily Living (ADLs), whereas commercially available alternatives are prohibitively expensive. Both options are typically difficult to don and doff and are cumbersome for extensive daily use. To overcome these limitations, we have designed, developed, and clinically validated the NuroSleeve, an innovative user-centered UE orthosis. Methods: This study introduces the design, implementation, and clinical evaluation of the NuroSleeve, a user-centered, lightweight, affordable, easy to don and doff 3D-printed UE active orthosis for improving function and independence in individuals living with UE neuromuscular impairment. Our primary goals are to develop a customized active UE brace that individuals with UE impairment can use to perform ADLs and to evaluate the benefits of incorporating the device into occupational therapy sessions. The trial is designed as a prospective, open-label, single-cohort feasibility study of eight-week sessions combined with at-home use of the device and implements an iterative device design process where feedback from participants and therapists inform future design improvements. Results: All participants learned how to independently don, doff, and use the NuroSleeve in ADLs, both in clinical therapy and in their home environments. All participants showed improvements in their Canadian Occupational Performance Measure (COPM), which was the primary clinical trial outcome measure. Furthermore, the participants and therapists provided valuable feedback to guide further development. Conclusions: Our results from non-clinical testing and clinical evaluation demonstrate that the NuroSleeve has met performance and safety requirements and effectively improves independent voluntary function during ADLs. The study’s encouraging preliminary findings indicate that the NuroSleeve has met its technical and clinical objectives while improving on the limitations of the existing UE orthoses due to its personalized and flexible approach to hardware and firmware design. Trial Registration: ClinicalTrials.gov identifier: NCT04798378, https://clinicaltrials.gov/ct2/show/NCT04798378, date of registration: March 15, 2021.