NCT06928857Completed
Study on the Effects of an EMG-controlled Functional Electrical Stimulator for Upper Limb for Post-stroke Patients
Pilot Study on the Effects Induced by an Electromyographic-controlled Functional Electrical Stimulator (FitFES) for Upper Limb Rehabilitation in Post-stroke Patients
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 29 Jan 2025
- Start date
- 3 Mar 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Stroke
- NCT number
- NCT06928857
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 3 Mar 2025 to the primary completion date, 31 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Epilepsy not medically controlled
- Thrombosis, thrombophlebitis
- 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
- Other neurological diseases other than stroke
- Diseases of internal organs
Age
- Score at the Mini Mental State Examination (adjusted for age and schooling) \< 24
Other
- 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
- Severe peripheral neuropathy
- Recent interventions
- Active stent carrier less than six months
- Acute arthritis
- Progressive muscular dystrophy
- Abdominal or inguinal hernias
- Undiagnosed back pain
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Fondazione Don Carlo Gnocchi Onlus Coordinator of this site? Confirm its status | La Spezia | Italy | Unknown status |
| IRCCS Fondazione Don Carlo Gnocchi ONLUS Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.