Study on the Effects of an EMG-controlled Functional Electrical Stimulator for Upper Limb for Post-stroke Patients

Launched by FONDAZIONE DON CARLO GNOCCHI ONLUS · Apr 14, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment method for stroke patients who have difficulty using their arms. The study is looking at a device called a functional electrical stimulator (FES), which uses small electrical signals to stimulate the muscles in the arm and help improve movement and strength. This can be an important part of rehabilitation, as it aims to help patients regain some function and independence after a stroke.

To participate in this trial, individuals must be at least 18 years old and have had their first stroke at least two weeks prior. They should have some muscle strength in their affected arm but not complete strength. However, there are certain health conditions that would prevent someone from joining, such as severe mental or physical health issues, certain types of severe diabetes, or other significant medical problems. Participants can expect to receive the FES treatment as part of their therapy, which could help them improve their arm function over time. If you or a loved one is interested in this study, it's a good idea to talk to a healthcare provider for more details.

Gender

ALL

Eligibility criteria

• 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 and less than 5 (excluding extremes).
• • Signed informed consent
• 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, 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