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
Fondazione Don Carlo Gnocchi Onlus
50 participants
Mar 3, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria26
- 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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Interventions
Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency. Each participant will perform task-oriented exercises while using the FitFES device.
Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency. Each participant will perform task-oriented exercises.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06928857