Hybrid assistive exoskeleton to support upper limb movement
Assessment of Feasibility, Functionality and Usability of an Hybrid Assistive Exoskeleton for Upper Limb: a Pilot Study
NA · Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro · NCT07000279
This study will try a hybrid assistive exoskeleton to help adults with upper limb weakness from stroke or brachial plexus injury perform everyday tasks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro (other) |
| Locations | 1 site (Budrio, Bologna) |
| Trial ID | NCT07000279 on ClinicalTrials.gov |
What this trial studies
Adults at least six months after stroke or brachial plexus injury with some preserved arm strength will use a hybrid exoskeleton while researchers test its functionality and usability. Participants will perform activities of daily living, a box-and-block task, and maximum reaching height tests while wearing the device. Inclusion requires Medical Research Council (MRC) muscle strength ≥2, cognitive ability to follow instructions, and no recent FES treatment or interfering implants. The work is conducted at a single center (Centro Protesi Inail, Budrio) and focuses on feasibility rather than long-term efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–65 who are at least six months post-stroke or post-brachial plexus injury, have MRC muscle strength of 2 or higher in the affected arm, can follow instructions, and have no implants or recent FES treatment that would interfere.
Not a fit: Patients with MRC strength below 2, significant pain (NRS >4), other neurological or orthopedic impairments, cognitive impairment (MMSE <24), implantable devices that interfere with FES, pregnancy, or unstable medical conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the device could improve arm function and increase independence in everyday activities for people with upper limb deficits.
How similar studies have performed: Active devices like MyoPro exist for elbow and wrist and there is supporting evidence for gravity compensation and FES, but hybrid upper-limb exoskeletons for everyday use remain relatively novel with limited clinical proof.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Budrio, Bologna
- Centro Protesi Inail — Budrio, Bologna, Italy (RECRUITING)
Study contacts
- Study coordinator: Emanuele Gruppioni, PhD
- Email: e.gruppioni@inail.it
- Phone: +39 051 6936 609
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Upper Limb Deficits, assistive exoskeleton, upper arm, post stroke, brachial plexus injury, orthesis, functional electrical stimulation, activity of daily living