New robotic arm exoskeleton aims to restore daily function after stroke or nerve injury
NCT ID NCT07000279
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study is testing a portable hybrid exoskeleton that combines a robotic arm support with electrical stimulation to help people with upper limb deficits from stroke or brachial plexus injuries. Ten participants will perform tasks like moving blocks and daily activities with and without the device to see if it improves movement and usability. The goal is to assess safety, performance, and user satisfaction.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hybrid assistive exoskeleton (robotic exoskeleton plus functional electrical stimulation)
- What this could lead to
- If it works, this device could help people with arm weakness regain independence in daily activities like eating and drinking.
- What could go wrong
- This is a very small pilot study with only 10 participants, so results may not apply to everyone. The device is still experimental and may have technical issues or not provide enough benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centro Protesi Inail
RECRUITINGBudrio, Bologna, 40054, Italy
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