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Can a Muscle-Reading stimulator rebuild stroke arm movement?

NCT ID NCT06928857

Symptom relief Sponsor: Fondazione Don Carlo Gnocchi ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing whether an electromyography-controlled functional electrical stimulator (FitFES) helps stroke survivors regain arm and hand function. The device reads muscle signals and delivers electrical stimulation during task-oriented exercises. Fifty adults who had a first stroke at least two weeks earlier will receive 15 one-hour rehabilitation sessions, either with the FitFES device or with traditional therapy. The trial measures changes in arm movement, hand dexterity, and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an electromyography-controlled functional electrical stimulator (FitFES) used during task-oriented arm exercises
What this could lead to
If it works, this could give stroke survivors a therapy that tailors electrical stimulation to their own muscle signals, possibly improving arm and hand recovery more than standard exercises alone.
What could go wrong
This is a small pilot study, so any benefit may be modest or may not hold up in larger trials. Electrical stimulation can cause skin irritation or discomfort, and recovery varies widely between people.

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

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

50 people

The number who actually took part.

Started

Mar 2025

Finished

Dec 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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: * 18 years or older * Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks * Medical Research Council score for at least one upper limb muscle greater than 0 and less than 5 (excluding extremes). * Signed informed consent Exclusion Criteria: * Score at the Mini Mental State Examination (adjusted for age and schooling) \< 24 * Clinical evidence in the case of visual disturbance, ideomotor apraxia, behavioral disorders, neglect, sensory, visual and auditory disturbances of severe degree or otherwise that prevent use of the device * Major head trauma * Cardio-respiratory or internal clinical instability * State of pregnancy or lactation * Severe spasticity (Ashworth \> 3) * Skin integrity problems at the interface surface with the device * Implanted electronic devices * Epilepsy not medically controlled * Severe peripheral neuropathy * Recent interventions * Thrombosis, thrombophlebitis * Active stent carrier less than six months * Severe forms of arteriosclerosis, arterial circulatory disorders * Hypertension not treated * Cardiac arrhythmias * Hemorrhagic disorders (hemophilia) * Severe forms of diabetes mellitus * Known allergy to materials making up the device or its applied parts * Cancer or tumour disease * Acute arthritis * Other neurological diseases other than stroke * Progressive muscular dystrophy * Abdominal or inguinal hernias * Undiagnosed back pain * Diseases of internal organs

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Conditions

The condition(s) this trial relates to.

stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stroke

Contacts and locations

Locations

  • Fondazione Don Carlo Gnocchi Onlus

    La Spezia, 19125, Italy

  • IRCCS Fondazione Don Carlo Gnocchi Onlus

    Milan, 20148, Italy

  • Ospedale Policlinico San Martino

    Genova, 16132, Italy

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