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NCT07098572Recruiting

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

Efficacy of EMG-triggered Four-Channel Functional Electrical Stimulation vs. Cyclic One-Channel Electrical Stimulation on Moderate Arm/Hand Paresis in Subacute Stroke Patients. A Randomized Controlled Single Blinded Multicenter Study

Source: ClinicalTrials.gov · Last updated 14 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
44 (estimated)
First submitted
24 Jul 2025
Start date
12 Aug 2025
Primary completion date
Jan 2028
Lead sponsor
MED-EL Elektromedizinische Geräte GmbH
Diseases
Stroke
NCT number
NCT07098572

What you commit to

  • Study type: Interventional
  • Planned participants: 44
  • From 12 Aug 2025 to the primary completion date, Jan 2028
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Implanted defibrillators, brain stimulators, pacemakers, medication pumps
  • Participation in other pharmacological clinical investigations within four weeks prior to enrolment

Other illness

  • Therapy-resistant epilepsy
  • Fever or infectious diseases
  • Inflammatory or tumorous skin diseases in the stimulation area,
  • Known allergic reactions to components of the investigational medical device

Other

  • Lack of compliance with any inclusion criteria
  • Thromboses or vein inflammations
  • Severe contractures of the affected extremity
  • Wounds in the stimulation area
  • Pregnancy
  • Unstable psychological status
  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
KABEG Gailtal-Klinik LKH Hermagor
Coordinator of this site? Confirm its status
HermagorAustriaRecruiting
Kepler Universitätsklinikum Linz
Coordinator of this site? Confirm its status
LinzAustriaRecruiting
Ö. Landeskrankenhaus Hochzirl - Natters, Standort Hochzirl
Coordinator of this site? Confirm its status
ZirlAustriaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.