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

RecruitingNAAges 18 Years - 65 YearsAllIstituto Nazionale Assicurazione contro gli Infor…
NCT07000279 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 whole upper limb, the shoulder and also a part of the chest. The majority of such injuries is caused by traumatic events that involve young and healty people in most cases and motor impairment varies together with either the type (complete or incomplete) or the site of injury. It follows the need to realize devices capable of restoring people everyday life independence. To assist these patients, the most common solutions are passive ortheses that give support to shoulder and forearm without actively enhancing limb functionalities. MyoPro (by MIT, Myomo1) is the only active device available for elbow and wrist, even not completely proven for everyday life yet. It comes from scientific evidenc

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📋 Eligibility rules (as published)
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
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What it tests

  • Assistive exoskeleton for activities of daily living (ADLs)
  • Assistive exoskeleton for box and block
  • Assistive exoskeleton for maximum reaching height
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Where

1 site
Centro Protesi Inail
Budrio, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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