Ischemic Stroke, Moderate Arm Paresis
Conditions
Keywords
Arm Paresis, Hand Paresis, Stiwell Profes, Electrostimulation, Ischemic stroke, Rehabilitation
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.
Interventions
DEVICECyclic single channel neuromuscular stimulation
Cyclic single channel neuromuscular stimulation is used to trigger repetitive muscular contractions
DEVICEElectromyogram-triggered 4 channel neuromuscular stimulation
EMG-MES provides biofeedback by using electromyographic signals to trigger muscular contractions
Sponsors
MED-EL Elektromedizinische Geräte GesmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Impact Scale (SIS) subscale Recovery | pre-intervention to 3 weeks | Scores between 0 and 100, higher meaning a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Impact Scale (SIS), subscale strength | pre-intervention to 3 weeks | 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) | pre-intervention to 3 weeks | Scores between 0 and 100, higher meaning a better outcome |
| Stroke impact scale (SIS) subscale mobility | pre-intervention to 3 weeks | Scores between 0 and 100, higher meaning a better outcome |
| Stroke impact scale (SIS) subscale hand function | pre-intervention to 3 weeks | Scores between 0 and 100, higher meaning a better outcome |
| Fugl-Meyer Assessment - upper extremity (FMA-UE) | pre-intervention to 3 weeks | Scores between 0 and 100, higher meaning a better outcome |
| Action Research Arm Test (ARAT) | pre-intervention to 3 weeks | Scores between 0 and 57, higher meaning a better outcome |
| Safety assessment | through study completion, an average of 15 weeks | Assessment of device related adverse events |
Countries
Austria
Contacts
CONTACTFlorian Schwarze, PhD
Outcome results
None listed