Moderate Arm ParesisMKES2NCT07098572
Comparison of Four-Channel Functional Electrical Stimulation vs. One-Channel Electrical Stimulation on Moderate Arm/Hand Paresis in Subacute Stroke Patients
A study testing Cyclic single channel neuromuscular stimulation and Electromyogram-triggered 4 channel neuromuscular stimulation in people with Moderate Arm Paresis and Ischemic Stroke, run by MED-EL Elektromedizinische Geräte GmbH at 3 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Moderate Arm Paresis, Ischemic Stroke
- What is being tested?
- Cyclic single channel neuromuscular stimulation and Electromyogram-triggered 4 channel neuromuscular stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesAustria
- Study dates
- 12 Aug 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Lack of compliance with any inclusion criteria
- 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
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Austria3 sites, 3 recruiting
- Recruiting
KABEG Gailtal-Klinik LKH Hermagor
Hermagor, Carinthia, 9620
Christina Hohenwarter, Dr. med., +43 4282 2220, christina.hohenwarter@kabeg.at
- Recruiting
Kepler Universitätsklinikum Linz
Linz, Upper Austria, 4021
Christian Mittermaier, Dr. med., +43 5 7680 83, christian.mittermaier@kepleruniklinikum.at
- Recruiting
Ö. Landeskrankenhaus Hochzirl - Natters, Standort Hochzirl
Zirl, Tyrol, 6170
Elke Pucks-Faes, Dr. med., +43 50 504, elke.pucks-faes@tirol-kliniken.at
About this study
Official title: 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
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
- Being tested
- Cyclic single channel neuromuscular stimulation, Electromyogram-triggered 4 channel neuromuscular stimulation
- Keywords
- Arm Paresis, Hand Paresis, Stiwell Profes, Electrostimulation, Ischemic stroke, Rehabilitation
- Medical subject headings
- Ischemic Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclic single channel neuromuscular stimulationDevice
Cyclic single channel neuromuscular stimulation is used to trigger repetitive muscular contractions
Electromyogram-triggered 4 channel neuromuscular stimulationDevice
Also called EMG-MES
EMG-MES provides biofeedback by using electromyographic signals to trigger muscular contractions
| Study group | Role | What they receive |
|---|---|---|
| Cyclic Neuromuscular Electrical Stimulation (cNMES) | Active comparator | Single channel cyclic neuromuscular stimulation used for the rehabilitation of moderate arm paresis Receives: 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 Receives: Device: Electromyogram-triggered 4 channel neuromuscular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Impact Scale (SIS) subscale Recovery
Scores between 0 and 100, higher meaning a better outcome
Measured: pre-intervention to 3 weeks
Secondary outcomes (7)
Stroke Impact Scale (SIS), subscale strength
Scores between 0 and 100, higher meaning a better outcome
Measured: pre-intervention to 3 weeks
Stroke impact scale (SIS) subscale Activities of Daily Living (ADL) / Instrumental Activities of Daily Living (IADL)
Scores between 0 and 100, higher meaning a better outcome
Measured: pre-intervention to 3 weeks
Stroke impact scale (SIS) subscale mobility
Scores between 0 and 100, higher meaning a better outcome
Measured: pre-intervention to 3 weeks
Stroke impact scale (SIS) subscale hand function
Scores between 0 and 100, higher meaning a better outcome
Measured: pre-intervention to 3 weeks
Fugl-Meyer Assessment - upper extremity (FMA-UE)
Scores between 0 and 100, higher meaning a better outcome
Measured: pre-intervention to 3 weeks
Action Research Arm Test (ARAT)
Scores between 0 and 57, higher meaning a better outcome
Measured: pre-intervention to 3 weeks
Safety assessment
Assessment of device related adverse events
Measured: through study completion, an average of 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start12 Aug 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Arm ParesisStudies of the same condition, open and under way.
- More trials run by MED-EL Elektromedizinische Geräte GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098572
- Sponsor's protocol ID
- MED-EL_CRD_2024_02
- Acronym
- MKES2
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07098572
- Acronym / sponsor ID
- MKES2 / MED-EL_CRD_2024_02
- Conditions
- Moderate Arm Paresis, Ischemic Stroke
- Keywords
- Arm Paresis, Hand Paresis, Stiwell Profes, Electrostimulation, Ischemic stroke, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclic Neuromuscular Electrical Stimulation (cNMES) | Active comparator | Device: Cyclic single channel neuromuscular stimulationSingle channel cyclic neuromuscular stimulation used for the rehabilitation of moderate arm paresis |
| Electromyographic-triggered Multichannel Electrical Stimulation (EMG-MES) | Experimental | Device: Electromyogram-triggered 4 channel neuromuscular stimulationEMG-triggered, four channel neuromuscular stimulation used for the rehabilitation of moderate arm paresis |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- Lack of compliance with any inclusion criteria
- Implanted defibrillators, brain stimulators, pacemakers, medication pumps
- Therapy-resistant epilepsy
- Fever or infectious diseases
- Inflammatory or tumorous skin diseases in the stimulation area,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclic single channel neuromuscular stimulationCyclic single channel neuromuscular stimulation is used to trigger repetitive muscular contractions | Device | Cyclic Neuromuscular Electrical Stimulation (cNMES) |
| Electromyogram-triggered 4 channel neuromuscular stimulationAlso: EMG-MESEMG-MES provides biofeedback by using electromyographic signals to trigger muscular contractions | Device | Electromyographic-triggered Multichannel Electrical Stimulation (EMG-MES) |
Primary outcome
Stroke Impact Scale (SIS) subscale Recovery
Time frame: pre-intervention to 3 weeks
Scores between 0 and 100, higher meaning a better outcome
7 secondary outcomes
Stroke Impact Scale (SIS), subscale strength
Time frame: pre-intervention to 3 weeks
Stroke impact scale (SIS) subscale Activities of Daily Living (ADL) / Instrumental Activities of Daily Living (IADL)
Time frame: pre-intervention to 3 weeks
Stroke impact scale (SIS) subscale mobility
Time frame: pre-intervention to 3 weeks
Stroke impact scale (SIS) subscale hand function
Time frame: pre-intervention to 3 weeks
Fugl-Meyer Assessment - upper extremity (FMA-UE)
Time frame: pre-intervention to 3 weeks
Action Research Arm Test (ARAT)
Time frame: pre-intervention to 3 weeks
Safety assessment
Time frame: through study completion, an average of 15 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclic single channel neuromuscular stimulation and Electromyogram-triggered 4 channel neuromuscular stimulation in people with Moderate Arm Paresis and Ischemic Stroke, run by MED-EL Elektromedizinische Geräte GmbH at 3 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Schwarze, PhD (+435 77 88, studies@medel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Impact Scale (SIS) subscale Recovery (time frame: pre-intervention to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.