Actively Recruiting
Study on the Effects of an EMG-controlled Functional Electrical Stimulator for Upper Limb for Post-stroke Patients
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-04-15
50
Participants Needed
3
Research Sites
39 weeks
Total Duration
On this page
Sponsors
F
Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
I
Istituto Italiano di Tecnologia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on the Effects of an EMG-controlled Functional Electrical Stimulator for Upper Limb for Post-stroke Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Signed informed consent
You will not qualify if you...
- Mini Mental State Examination score (adjusted for age and schooling) less than 24
- Severe visual disturbance, ideomotor apraxia, behavioral disorders, neglect, or severe sensory, visual, or auditory disturbances preventing device use
- Major head trauma
- Cardio-respiratory or internal clinical instability
- Pregnancy or lactation
- Severe spasticity (Ashworth greater than 3)
- Skin problems at the device interface
- Implanted electronic devices
- Uncontrolled epilepsy
- Severe peripheral neuropathy
- Recent interventions
- Thrombosis or thrombophlebitis
- Active stent carrier less than six months
- Severe arteriosclerosis or arterial circulatory disorders
- Untreated hypertension
- Cardiac arrhythmias
- Hemorrhagic disorders (hemophilia)
- Severe diabetes mellitus
- Known allergy to device materials
- Cancer or tumor disease
- Acute arthritis
- Neurological diseases other than stroke
- Progressive muscular dystrophy
- Abdominal or inguinal hernias
- Undiagnosed back pain
- Diseases of internal organs
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Ospedale Policlinico San Martino
Genova, Italy, 16132
Actively Recruiting
2
Fondazione Don Carlo Gnocchi Onlus
La Spezia, Italy, 19125
Actively Recruiting
3
IRCCS Fondazione Don Carlo Gnocchi Onlus
Milan, Italy, 20148
Actively Recruiting
Research Team
A
Alessandro Viganò, MD, PhD
CONTACT
G
Gaia Bailo, Eng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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