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

NCT ID: NCT07098572

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2028-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cyclic Neuromuscular Electrical Stimulation (cNMES)

Single channel cyclic neuromuscular stimulation used for the rehabilitation of moderate arm paresis

Group Type: ACTIVE_COMPARATOR

Cyclic single channel neuromuscular stimulation

Intervention Type: DEVICE

Cyclic single channel neuromuscular stimulation is used to trigger repetitive muscular contractions

Electromyographic-triggered Multichannel Electrical Stimulation (EMG-MES)

EMG-triggered, four channel neuromuscular stimulation used for the rehabilitation of moderate arm paresis

Group Type: EXPERIMENTAL

Electromyogram-triggered 4 channel neuromuscular stimulation

Intervention Type: DEVICE

EMG-MES provides biofeedback by using electromyographic signals to trigger muscular contractions

Interventions

Cyclic single channel neuromuscular stimulation

Cyclic single channel neuromuscular stimulation is used to trigger repetitive muscular contractions

Intervention Type: DEVICE

Electromyogram-triggered 4 channel neuromuscular stimulation

EMG-MES provides biofeedback by using electromyographic signals to trigger muscular contractions

Intervention Type: DEVICE

Other Intervention Names

EMG-MES

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MED-EL Elektromedizinische Geräte GesmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

KABEG Gailtal-Klinik LKH Hermagor

Hermagor, Carinthia, Austria

Site Status: RECRUITING

Ö. Landeskrankenhaus Hochzirl - Natters, Standort Hochzirl

Zirl, Tyrol, Austria

Site Status: RECRUITING

Kepler Universitätsklinikum Linz

Linz, Upper Austria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Florian Schwarze, PhD

Role: CONTACT

studies@medel.com

+435 77 88

Facility Contacts

Christina Hohenwarter, Dr. med.

Role: primary

christina.hohenwarter@kabeg.at

+43 4282 2220

Elke Pucks-Faes, Dr. med.

Role: primary

elke.pucks-faes@tirol-kliniken.at

+43 50 504

Christian Mittermaier, Dr. med.

Role: primary

christian.mittermaier@kepleruniklinikum.at

+43 5 7680 83

Other Identifiers

MED-EL_CRD_2024_02

Identifier Type: -

Identifier Source: org_study_id