Status:
RECRUITING
Study on the Effects of an EMG-controlled Functional Electrical Stimulator for Upper Limb for Post-stroke Patients
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
Istituto Italiano di Tecnologia
Ospedale Policlinico San Martino
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 techn...
Detailed Description
FitFES is a wearable and non-invasive device that provides continuous stimulation set according to the residual myoelectric activity of hemiparetic muscles. Its bioinspired functioning has been implem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06928857
Start Date
March 3 2025
End Date
December 1 2025
Last Update
April 15 2025
Active Locations (3)
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1
Ospedale Policlinico San Martino
Genova, Italy, 16132
2
Fondazione Don Carlo Gnocchi Onlus
La Spezia, Italy, 19125
3
IRCCS Fondazione Don Carlo Gnocchi Onlus
Milan, Italy, 20148