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.
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 tend to lack flexibility in control and activation methods. Both options are typically difficult to don and doff and may be uncomfortable for extensive daily use due to their lack of personalization. To overcome these limitations, we have designed, developed, and clinically evaluated the NuroSleeve, an innovative user-centered UE hybrid orthosis. Methods This study introduces the design, implementation, and clinical evaluation of the NuroSleeve, a user-centered hybrid device that incorporates a lightweight, easy to don and doff 3D-printed motorized UE orthosis and a functional electrical stimulation (FES) component. Our primary goals are to develop a customized hybrid device that individuals with UE neuromuscular 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 informs design improvement cycles. 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, 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 feasibility and safety goals and effectively improved independent voluntary function during ADLs. The study’s encouraging preliminary findings indicate that the NuroSleeve has met its technical and clinical objectives while improving upon the limitations of the existing UE orthoses owing 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.
As spinal cord injury disrupts the communication between neural circuitry, electrical stimulation of the spinal cord may improve the rewiring and recovery of the affected pathways. Although significant recovery was initially observed in invasive implantable epidural stimulation settings, recent advancements in non-invasive transcutaneous spinal cord stimulation have shown the potential for significant improvements in individuals living with Spinal Cord Injury. In this study, we introduce the Reynolds Innovative Spinal Electrical Stimulation (RISES) technology which is an innovative person-tailored and task-specific stimulation system intended to optimize stimulation parameters in real-time with its multi-data acquisition and closed-loop capabilities. We aimed to pilot the safety and feasibility of the RISES system by implementing the developed technology as part of an intervention modeled on clinical rehabilitation. The results confirmed that the technology was able to establish a framework for achieving safe and feasible neurological recovery evident in enhancements of muscle activation for proximal muscles, and without any indication of physiological adverse effects.
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