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

Recruiting now · Not applicable

Conditions studied: Moderate Arm Paresis, Ischemic Stroke

In brief

This study will compare two treatments that may help participants recover after having suffered from stroke. Persons who experience weakness or paralysis of their arms/hands will be randomly placed in one of two groups. Each receives treatment five times a week for three weeks. One group will be treated with electrostimulation following a cyclic pattern (control treatment), the other group will be treated with electrostimulation triggered by nerve signals (i.e. stimulation starts when they deliberately try to move their arm (investigational treatment). Before and after the three weeks and additionally 12 weeks later, the ability to move the arm and hand will be documented with standardized tests.

Key facts

Study ID: NCT07098572
Run by: MED-EL Elektromedizinische Geräte GesmbH
People needed: 44
Starts: 2025-07-14
Expected to finish: 2028-01-01
Last updated by the study team: 2025-08-26

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

KABEG Gailtal-Klinik LKH Hermagor — Hermagor, Carinthia, Austria (enrolling)
Ö. Landeskrankenhaus Hochzirl - Natters, Standort Hochzirl — Zirl, Tyrol, Austria (enrolling)
Kepler Universitätsklinikum Linz — Linz, Upper Austria, Austria (enrolling)

Full record on ClinicalTrials.gov

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