Menu
Recruiting NCT07098572

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

No phase Interventional Moderate Arm Paresis Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cyclic single channel neuromuscular stimulation, Electromyogram-triggered 4 channel neuromuscular stimulation.
Who it may be relevant to
Registry conditions: Moderate Arm Paresis, Ischemic Stroke. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Stroke Impact Scale (SIS) subscale Recovery [Time frame: pre-intervention to 3 weeks]
Secondary outcome measures (7)
  • 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]

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.

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Austria · 3 centers
  • KABEG Gailtal-Klinik LKH Hermagor — Hermagor
  • Ö. Landeskrankenhaus Hochzirl - Natters, Standort Hochzirl — Zirl
  • Kepler Universitätsklinikum Linz — Linz

Identifiers

NCT: NCT07098572 · MED-EL_CRD_2024_02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗