I couldn't find a picture so ask your doctor how likely this will restore your arm function.
The NuroSleeve, a user-centered 3D printed hybrid orthosis for individuals with upper extremity impairment
Journal of NeuroEngineering and Rehabilitation volume 20, Article number: 103 (2023)
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 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.
Background
Neuromuscular disorders impose a significant socioeconomic burden on society. There are over 7 million stroke survivors in the United States alone [1, 2], 62% of whom have a loss of dexterity in their upper extremities (UE) [3]. Approximately 291,000 Americans are living with disability due to spinal cord injury (SCI) [4], and Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (BMD) combined affect around 14 in 100,000 American males [5]. Neurological disorders and diseases often result in permanent disability that prevents individuals from performing Activities of Daily Living (ADLs) independently [4, 6]. Stroke [1, 7, 8], SCI [4, 9, 10], and muscular dystrophy (MD) frequently result in debilitating UE motor impairments that persist beyond rehabilitation discharge [11, 12]. Individuals with moderate to severe neurological UE impairment frequently exhibit limited active movement in their paretic elbow and little to no active movement in their paretic wrists and fingers [13, 14].
Rehabilitation therapies that implement assistive neurotechnology devices tend to improve functional motor recovery, reducing impairment and improving independence in ADLs, quality of life, and community participation [15,16,17,18,19]. Over the past six decades, it has been shown that the use of active wearable neurotechnology devices benefits individuals living with UE impairment by helping them perform ADLs [20,21,22].
Currently, commercially available active UE orthoses for home use can be divided into two groups: (1) mechanically actuated orthoses [23,24,25,26,27], which use either electric or pneumatic motors to achieve motion; and (2) Functional Electrical Stimulation (FES) orthoses [28,29,30] which electrically stimulate muscles to achieve motion. The application of electrical stimulation to a person's muscles depolarizes peripheral neurons and elicits muscle contractions, allowing the individial to perform a movement. FES can benefit individuals by substituting or enhancing movement. Repeated muscle activation using FES may also increase voluntary motor control. This suggests that the use of FES devices improves motor recovery and can serve as a rehabilitation technique as well as assist with ADLs [31, 32]. Thus, FES has evolved into a crucial treatment approach that clinicians may use to help individuals with stroke and SCI regain the capacity to stand, walk, reach, and grasp [33].
Widespread use of the cummercially available active orthoses is hindered by several factors: (1) the challenge of making them form-fitting, comfortable, authentic, easy to use, portable, and lightweight; (2) the inability to customize the placement of sensors as input controls and effectors to optimize user movements; and (3) the lack of rehabilitation professionals skilled in training individuals on how to integrate the orthosis into daily routines. To the best of our knowledge, no currently available commercial orthosis offers all the aforementioned factors for restoring UE functionality during ADLs in “real-world” situations [34,35,36,37,38,39,40,41].
Academically fabricated motorized UE orthoses have their own limitations; they often need to be fixed to a wheelchair or stationary surface (e.g., a table) [42,43,44] or require support from the person’s back and shoulders [45] in order to function. Our clinical experience suggests that most individuals would not find such devices practical to use in ADLs or in the community. Soft robotic sleeves [46,47,48,49,50,51,52] provide an alternative to motor-based approaches; however, such sleeves are not easy to don and doff, and most require an air compressor or compressed gas tanks to function. Hence, soft robotic sleeves may not easily find their market without first addressing their practicality and usability issues.
To overcome the limitations of the currently available UE orthoses, the next generation of UE devices must be simple to use to encourage acceptance and integration in ADLs while having favorable aesthetics for widespread adoption. Specifically, a user-friendly orthosis should be effective, comfortable, portable, form-fitting, safe and easy to use, easy to don and doff, and offer the individual a variety of options for controlling it. Furthermore, it should be lightweight; this is paramount because continuous usage of heavy UE orthoses may have a detrimental effect on user satisfaction and compliance and may contribute to physical problems such as pressure point formation, muscular fatigue, perspiration, and skin irritation. Also, an important requirement for the UE orthoses to be effectively incorporated into ADLs may be the battery life of more than 8 h, making it possible to be used each day on a single battery charge. These numerous requirements cannot be met in devices that are designed following the “one-size-fits-all” principle without accounting for the unique needs of each individual [34,35,36,37,38,39,40,41].
This study introduces the design, development, implementation, and clinical evaluation of the NuroSleeve, a novel user-centric active UE orthosis. The NuroSleeve design accommodates the unique needs and conditions of individuals by integrating (1) a user-specific control mechanism, (2) a custom 3D-printed, lightweight, and easy to don and doff motorized splint, and (3) an off-the-shelf FES unit to take advantage of the electrical stimulation benefits [34,35,36,37, 40]. In addition, the design process incorporates feedback from individuals to tailor the system components and functionality for their personal needs and inform overall design improvements. Our goal in developing the NuroSleeve is to meet the unique needs of individuals and promote the adoption of the technology in clinical settings, at home, and in the community.
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