NCT06928857 Study on the Effects of an EMG-controlled Functional Electrical Stimulator for Upper Limb for Post-stroke Patients
| NCT ID | NCT06928857 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Don Carlo Gnocchi ETS |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-03-03 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Upper limb disabilities are among the most debilitating issues after a cerebral stroke. One promising approach in motor rehabilitation is the use of functional electrical stimulation (FES). This technique can be integrated into daily therapy to follow an adaptive approach, exploiting the residual capacities of patients. FES can help to stimulate the affected muscles, improve coordination and strengthen the weakened muscles, thus supporting the rehabilitation process.
Eligibility Criteria
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
Contact & Investigator
Maurizio Ferrarin, PhD, Eng
PRINCIPAL INVESTIGATOR
IRCCS Fondazione Don Carlo Gnocchi ONLUS
Frequently Asked Questions
Who can join the NCT06928857 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06928857 currently recruiting?
Yes, NCT06928857 is actively recruiting participants. Contact the research team at avigano@dongnocchi.it for enrollment information.
Where is the NCT06928857 trial being conducted?
This trial is being conducted at Genova, Italy, La Spezia, Italy, Milan, Italy.
Who is sponsoring the NCT06928857 clinical trial?
NCT06928857 is sponsored by Fondazione Don Carlo Gnocchi ETS. The principal investigator is Maurizio Ferrarin, PhD, Eng at IRCCS Fondazione Don Carlo Gnocchi ONLUS. The trial plans to enroll 50 participants.
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