Status:
RECRUITING
Assessment of Feasibility, Functionality and Usability of an Hybrid Assistive Exoskeleton for Upper Limb
Lead Sponsor:
Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Collaborating Sponsors:
Università Campus Bio-Medico di Roma (UCBM)
Scuola Superiore Sant'Anna di Pisa
Conditions:
Upper Limb Deficits
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
People affected by stroke or brachial plexus injuries experience huge impairment in using upper limbs for everyday life activities. Brachial plexus is responsible of sensory-motor innervation of the w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07000279
Start Date
September 5 2025
End Date
December 1 2025
Last Update
September 29 2025
Active Locations (1)
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1
Centro Protesi Inail
Budrio, Bologna, Italy, 40054