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

NCT07098572 | Recruiting

• 1 other identifier: MED-EL_CRD_2024_02
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

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

Keywords

Arm Paresis; Hand Paresis; Stiwell Profes; Electrostimulation; Ischemic stroke; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Stroke Impact Scale (SIS) subscale Recovery

  Scores between 0 and 100, higher meaning a better outcome

  pre-intervention to 3 weeks

Secondary Outcomes (7)

• Stroke Impact Scale (SIS), subscale strength

  pre-intervention to 3 weeks

• Stroke impact scale (SIS) subscale Activities of Daily Living (ADL) / Instrumental Activities of Daily Living (IADL)

  pre-intervention to 3 weeks

• Stroke impact scale (SIS) subscale mobility

  pre-intervention to 3 weeks

• Stroke impact scale (SIS) subscale hand function

  pre-intervention to 3 weeks

• Fugl-Meyer Assessment - upper extremity (FMA-UE)

  pre-intervention to 3 weeks

Study Arms (2)

Cyclic Neuromuscular Electrical Stimulation (cNMES)

ACTIVE COMPARATOR

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

Device: Cyclic single channel neuromuscular stimulation

Electromyographic-triggered Multichannel Electrical Stimulation (EMG-MES)

EXPERIMENTAL

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

Device: Electromyogram-triggered 4 channel neuromuscular stimulation

Interventions

Cyclic single channel neuromuscular stimulation DEVICE

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

Cyclic Neuromuscular Electrical Stimulation (cNMES)

Electromyogram-triggered 4 channel neuromuscular stimulation DEVICE

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

Also known as: EMG-MES

Electromyographic-triggered Multichannel Electrical Stimulation (EMG-MES)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (3)

KABEG Gailtal-Klinik LKH Hermagor

Hermagor, Carinthia, 9620, Austria

RECRUITING

Ö. Landeskrankenhaus Hochzirl - Natters, Standort Hochzirl

Zirl, Tyrol, 6170, Austria

RECRUITING

Kepler Universitätsklinikum Linz

Linz, Upper Austria, 4021, Austria

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Paresis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Florian Schwarze, PhD

CONTACT

+435 77 88; studies@medel.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 1, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

AU (3)