About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Lack of compliance with any inclusion criteria
Implanted defibrillators, brain stimulators, pacemakers, medication pumps
Therapy-resistant epilepsy
Fever or infectious diseases
Trial design
Parallel
Treatments tested in this trial
Cyclic single channel neuromuscular stimulation
DeviceCyclic single channel neuromuscular stimulation is used to trigger repetitive muscular contractions
Electromyogram-triggered 4 channel neuromuscular stimulation
DeviceEMG-MES provides biofeedback by using electromyographic signals to trigger muscular contractions
Treatment groups
Trial outcomes
Primary outcomes
Stroke Impact Scale (SIS) subscale Recovery
Scores between 0 and 100, higher meaning a better outcome
Secondary outcomes
Stroke Impact Scale (SIS), subscale strength
Scores between 0 and 100, higher meaning a better outcome
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
Stroke impact scale (SIS) subscale mobility
Scores between 0 and 100, higher meaning a better outcome
Stroke impact scale (SIS) subscale hand function
Scores between 0 and 100, higher meaning a better outcome
Sponsors and contacts
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