Comparison of Four-Channel Functional Electrical Stimulation vs. One-Channel Electrical Stimulation on Moderate Arm/Hand Paresis in Subacute Stroke Patients

Inclusion criteria

• First-time ischemic stroke with moderate arm paresis (Motricity Index - UE Sum-Score ≥ 40 ≤ 77 points) (Collin & Wade, 1990)
• Early to late subacute phase (7 days - 6 months) (Bernhardt et al., 2017)
• Existing ADL ability before the event (ICF d5 self-care, d6 domestic life, extent of problem ≤1 points) (WHO, 2001)
• Age ≥18 - 99 years
• Signed and dated ICF before the start of any study-specific procedure.

Exclusion criteria

• Lack of compliance with any inclusion criteria
• Implanted defibrillators, brain stimulators, pacemakers, medication pumps
• Therapy-resistant epilepsy
• Fever or infectious diseases
• Inflammatory or tumorous skin diseases in the stimulation area,
• Thromboses or vein inflammations
• Severe contractures of the affected extremity
• Wounds in the stimulation area
• Pregnancy
• Known allergic reactions to components of the investigational medical device
• Unstable psychological status
• Participation in other pharmacological clinical investigations within four weeks prior to enrolment
• Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study