NCT07098572

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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

• Moderate Arm Paresis
• Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Cyclic single channel neuromuscular stimulation	Cyclic single channel neuromuscular stimulation is used to trigger repetitive muscular contractions
DEVICE	Electromyogram-triggered 4 channel neuromuscular stimulation	EMG-MES provides biofeedback by using electromyographic signals to trigger muscular contractions

Timeline

• Start date: 2025-07-14
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-08-01
• Last updated: 2025-08-26

Locations

3 sites across 1 country: Austria