Phase
Condition
Stroke
Cerebral Ischemia
Treatment
EMG-based FES rehabilitation
Traditional rehabilitation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 andless than 5 (excluding extremes).
Signed informed consent
Exclusion
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, behavioraldisorders, neglect, sensory, visual and auditory disturbances of severe degree orotherwise 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
Study Design
Study Description
Connect with a study center
Ospedale Policlinico San Martino
Genova, 16132
ItalyActive - Recruiting
Fondazione Don Carlo Gnocchi Onlus
La Spezia, 19125
ItalyActive - Recruiting
IRCCS Fondazione Don Carlo Gnocchi Onlus
Milano, 20148
ItalyActive - Recruiting

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