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

Launched by ISTITUTO NAZIONALE ASSICURAZIONE CONTRO GLI INFORTUNI SUL LAVORO · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of assistive device designed to help people who have difficulty using their arms due to conditions like stroke or brachial plexus injuries, which affect the nerves controlling arm movement. The device combines a robotic exoskeleton and a technique called functional electrical stimulation (FES) to improve arm and hand function. Researchers want to see how well this device works, how easy it is to use, and whether it helps improve daily activities like eating or reaching for objects.

To participate in the trial, individuals should be between 18 and 65 years old and have experienced a stroke or brachial plexus injury at least six months ago, with some ability to move their arms. Participants will take part in up to six sessions where they will try out the device and perform tasks to measure how well they can use their arms with and without it. The trial aims to ensure the device is safe, effective, and user-friendly for those looking to regain independence in their daily lives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age between 18 and 65 years
• • post-stroke or brachial plexus injuries patients
• • upper limb motor deficit patients with Medical Research Council (MRC) Scale for Muscle Strength equal to or more than 2
• • number of months after lesion higher than 6
• • cognitive ability to follow instruction
• • no Functional Electrical Stimulation (FES) treatment within 6 months prior to the enrollment
• • absence of communication deficit
• Exclusion Criteria:
• • other nuerological or orthopaedic impairments
• • pain in injuried upper limb (Numeric Rating Scale (NRS) higher than 4)
• • cognitive impairments (Mini-Mental State Examination (MMSE) lower than 24)
• • implantable devices that can interfere with FES
• • muscle/neurological diseases that can get worse with FES
• • fever or infection
• • pregnancy or breastfeeding
• • absence of patient informed consent in written form
• • unstable medical condition