Pilot Study on a Portable Hybrid Assistive Exoskeleton to Improve Upper Limb Function in Post-Stroke and Brachial Plexus Injury Patients

What this Trial Is About

People who have had a stroke or brachial plexus injuries often face significant challenges using their upper limbs in daily activities. These injuries affect the nerves controlling movement and sensation in the shoulder, arm, and part of the chest, mainly caused by trauma in mostly young and healthy individuals. The goal of this research is to study a new hybrid active device designed to assist upper limb movement, aiming to improve motor function and independence in these patients by combining robotic support with functional electrical stimulation FES. This pilot study will assess the devices safety, functionality, usability, and effectiveness in this population. The device under investigation is a portable hybrid orthosis with two main parts a robotic exoskeleton that provides active assistance to the shoulder and elbow, and an FES module that aids wrist and hand movement. Participants will perform various tasks such as the box and block test, vertical reaching, and activities of daily living like eating and drinking both while wearing and not wearing the device. The study includes six sessions enrollment, device tuning and familiarization, and multiple task execution sessions for measuring outcomes. Healthy subjects will also be tested first to refine the procedure and improve user experience. Participants will spend up to 90 minutes per session completing these tasks with assessments including motor performance tests, muscle activation, and satisfaction questionnaires. Researchers will monitor adverse events, changes in task performance, usability ratings, and pain levels throughout the intervention days. The study will evaluate both objective measures like kinematics and muscle activity, and subjective measures such as user satisfaction and perceived workload to understand the devices impact comprehensively.

Assessment of Feasibility, Functionality and Usability of an Hybrid Assistive Exoskeleton for Upper Limb