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Background: In the United States, there are over seven million stroke survivors, with many facing gait impairments due to foot drop. This restricts their community ambulation and hinders functional independence, leading to several long-term health complications. Despite the best available physical therapy, gait function is incompletely recovered, and this occurs mainly during the acute phase post-stroke. Therapeutic options are limited currently. Novel therapies based on neurobiological principles have the potential to lead to long-term functional improvements. The Brain-Computer Interface (BCI) controlled Functional Electrical Stimulation (FES) system is one such strategy. It is based on Hebbian principles and has shown promise in early feasibility studies. The current study describes the BCI-FES clinical trial, which examines the safety and efficacy of this system, compared to conventional physical therapy (PT), to improve gait velocity for those with chronic gait impairment post-stroke. The trial also aims to find other secondary factors that may impact or accompany these improvements and establish the potential of Hebbian-based rehabilitation therapies. Methods: This Phase II clinical trial is a two-arm, randomized, controlled, longitudinal study with 66 stroke participants in the chronic (> 6 months) stage of gait impairment. The participants undergo either BCI-FES paired with PT or dose-matched PT sessions (three times weekly for four weeks). The primary outcome is gait velocity (10-meter walk test), and secondary outcomes include gait endurance, range of motion, strength, sensation, quality of life, and neurophysiological biomarkers. These measures are acquired longitudinally. Discussion: BCI-FES holds promise for gait velocity improvements in stroke patients. This clinical trial will evaluate the safety and efficacy of BCI-FES therapy when compared to dose-matched conventional therapy. The success of this trial will inform the potential utility of a Phase III efficacy trial. Trial registration: The trial was registered as "BCI-FES Therapy for Stroke Rehabilitation" on February 19, 2020, at clinicaltrials.gov with the identifier NCT04279067. [ABSTRACT FROM AUTHOR]

A significant number of individuals in the United States use assistive devices to enhance their mobility, and a considerable portion of those who depend on such aids require assistance from another individual in performing daily living activities. The introduction of robotic grippers has emerged as a transformative intervention, significantly contributing to the cultivation of independence. However, there are few grippers in the fields, which help with mimicking human hand-like movements (mostly grasping and pinching, with adoptive force control) to grasp and carry objects. Additionally, the data are not available even on how many Activities of Daily Living (ADL) objects they can handle. The goal of the research is to offer a new three-fingered gripper for daily living assistance, which can both grasp and pinch with adaptive force, enabling the capabilities of handling wide-ranging ADL objects with a minimal footprint. It is designed to handle 90 selective essential ADL objects of different shapes (cylindrical, irregular, rectangular, and round), sizes, weights, and textures (smooth, rough, bumpy, and rubbery). The gripper boasts a meticulously engineered yet simple design, facilitating seamless manufacturing through 3D printing technology without compromising its operational efficacy. The gripper extends its functionality beyond conventional grasping, featuring the capability to pinch (such as holding a credit card) and securely hold lightweight objects. Moreover, the gripper is adaptable to grasping various objects with different shapes and weights with controlled forces. In evaluation, the developed gripper went through rigorous load tests and usability tests. The results demonstrated that the users picked and placed 75 objects out of 90 daily objects. The gripper held and manipulated objects with dimensions from 25 mm to 80 mm and up to 2.9 kg. For heavy-weight objects (like books) where the centroid is far apart from the grasping areas, it is difficult to hold them due to high torque. However, objects' textures have no significant effect on grasping performance. Users perceived the simplicity of the gripper. Further investigation is required to assess the utility and longevity of grippers. This study contributes to developing assistive robots designed to enhance object manipulation, thereby improving individuals' independence and overall quality of life. [ABSTRACT FROM AUTHOR]