Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT07098572

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

Led by MED-EL Elektromedizinische Geräte GesmbH · Updated on 2025-08-26

44

Participants Needed

3

Research Sites

128 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • First-time ischemic stroke with moderate arm weakness (Motricity Index - UE Sum-Score between 40 and 77 points)
  • Stroke occurred within 7 days to 6 months before the study
  • Ability to perform daily living activities before the stroke (self-care and domestic life with minimal problems)
  • Age between 18 and 99 years
  • Signed informed consent form before starting any study procedures
Not Eligible

You will not qualify if you...

  • Not meeting any inclusion criteria
  • Having implanted defibrillators, brain stimulators, pacemakers, or medication pumps
  • Having therapy-resistant epilepsy
  • Having fever or infectious diseases
  • Having inflammatory or tumorous skin diseases in the area of stimulation
  • Having thromboses or vein inflammations
  • Having severe contractures of the affected arm or hand
  • Having wounds in the area where stimulation would be applied
  • Being pregnant
  • Known allergic reactions to parts of the medical device
  • Having unstable psychological conditions
  • Participation in other drug clinical trials within four weeks before joining this study
  • Any condition that the investigator believes increases risk or prevents full participation or completion of the study

AI-Screening

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Trial Site Locations

Total: 3 locations

1

KABEG Gailtal-Klinik LKH Hermagor

Hermagor, Carinthia, Austria, 9620

Actively Recruiting

2

Ö. Landeskrankenhaus Hochzirl - Natters, Standort Hochzirl

Zirl, Tyrol, Austria, 6170

Actively Recruiting

3

Kepler Universitätsklinikum Linz

Linz, Upper Austria, Austria, 4021

Actively Recruiting

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Research Team

F

Florian Schwarze, PhD

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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