Background Spinal cord injury (SCI) constitutes a major sociomedical problem, impacting approximately 0.32-0.64 million people each year worldwide; particularly, it impacts young individuals, causing long-term, often irreversible disability. While effective rehabilitation of patients with SCI remains a significant challenge, novel neural engineering technologies have emerged to target and promote dormant neuroplasticity in the central nervous system. Objective This study aims to develop, pilot test, and optimize a platform based on multiple immersive man-machine interfaces offering rich feedback, including (1) visual motor imagery training under high-density electroencephalographic recording, (2) mountable robotic arms controlled with a wireless brain-computer interface (BCI), (3) a body-machine interface (BMI) consisting of wearable robotics jacket and gloves in combination with a serious game (SG) application, and (4) an augmented reality module. The platform will be used to validate a self-paced neurorehabilitation intervention and to study cortical activity in chronic complete and incomplete SCI at the cervical spine. Methods A 3-phase pilot study (clinical trial) was designed to evaluate the NeuroSuitUp platform, including patients with chronic cervical SCI with complete and incomplete injury aged over 14 years and age-/sex-matched healthy participants. Outcome measures include BCI control and performance in the BMI-SG module, as well as improvement of functional independence, while also monitoring neuropsychological parameters such as kinesthetic imagery, motivation, self-esteem, depression and anxiety, mental effort, discomfort, and perception of robotics. Participant enrollment into the main clinical trial is estimated to begin in January 2023 and end by December 2023. Results A preliminary analysis of collected data during pilot testing of BMI-SG by healthy participants showed that the platform was easy to use, caused no discomfort, and the robotics were perceived positively by the participants. Analysis of results from the main clinical trial will begin as recruitment progresses and findings from the complete analysis of results are expected in early 2024. Conclusions Chronic SCI is characterized by irreversible disability impacting functional independence. NeuroSuitUp could provide a valuable complementary platform for training in immersive rehabilitation methods to promote dormant neural plasticity. Trial Registration ClinicalTrials.gov NCT05465486; https://clinicaltrials.gov/ct2/show/NCT05465486 International Registered Report Identifier (IRRID) PRR1-10.2196/41152
Background: This article presents the system architecture and validation of the NeuroSuitUp body–machine interface (BMI). The platform consists of wearable robotics jacket and gloves in combination with a serious game application for self-paced neurorehabilitation in spinal cord injury and chronic stroke. Methods: The wearable robotics implement a sensor layer, to approximate kinematic chain segment orientation, and an actuation layer. Sensors consist of commercial magnetic, angular rate and gravity (MARG), surface electromyography (sEMG), and flex sensors, while actuation is achieved through electrical muscle stimulation (EMS) and pneumatic actuators. On-board electronics connect to a Robot Operating System environment-based parser/controller and to a Unity-based live avatar representation game. BMI subsystems validation was performed using exercises through a Stereoscopic camera Computer Vision approach for the jacket and through multiple grip activities for the glove. Ten healthy subjects participated in system validation trials, performing three arm and three hand exercises (each 10 motor task trials) and completing user experience questionnaires. Results: Acceptable correlation was observed in 23/30 arm exercises performed with the jacket. No significant differences in glove sensor data during actuation state were observed. No difficulty to use, discomfort, or negative robotics perception were reported. Conclusions: Subsequent design improvements will implement additional absolute orientation sensors, MARG/EMG based biofeedback to the game, improved immersion through Augmented Reality and improvements towards system robustness.
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