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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
Cyclic single channel neuromuscular stimulation is used to trigger repetitive muscular contractions
EMG-MES provides biofeedback by using electromyographic signals to trigger muscular contractions
KABEG Gailtal-Klinik LKH Hermagor
Hermagor, Carinthia, Austria
RECRUITINGÖ. Landeskrankenhaus Hochzirl - Natters, Standort Hochzirl
Zirl, Tyrol, Austria
RECRUITINGKepler Universitätsklinikum Linz
Linz, Upper Austria, Austria
RECRUITINGStroke Impact Scale (SIS) subscale Recovery
Scores between 0 and 100, higher meaning a better outcome
Time frame: pre-intervention to 3 weeks
Stroke Impact Scale (SIS), subscale strength
Scores between 0 and 100, higher meaning a better outcome
Time frame: 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
Time frame: pre-intervention to 3 weeks
Stroke impact scale (SIS) subscale mobility
Scores between 0 and 100, higher meaning a better outcome
Time frame: pre-intervention to 3 weeks
Stroke impact scale (SIS) subscale hand function
Scores between 0 and 100, higher meaning a better outcome
Time frame: pre-intervention to 3 weeks
Fugl-Meyer Assessment - upper extremity (FMA-UE)
Scores between 0 and 100, higher meaning a better outcome
Time frame: pre-intervention to 3 weeks
Action Research Arm Test (ARAT)
Scores between 0 and 57, higher meaning a better outcome
Time frame: pre-intervention to 3 weeks
Safety assessment
Assessment of device related adverse events
Time frame: through study completion, an average of 15 weeks
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