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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMED-EL Elektromedizinische Geräte GesmbH

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Lack of compliance with any inclusion criteria

Implanted defibrillators, brain stimulators, pacemakers, medication pumps

Therapy-resistant epilepsy

Fever or infectious diseases

Trial design

Treatments tested in this trial

  • Cyclic single channel neuromuscular stimulation
  • Electromyogram-triggered 4 channel neuromuscular stimulation

Treatment groups

44 Participants
are divided into 2 treatment groups