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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclic Neuromuscular Electrical Stimulation (cNMES) | Active Comparator | Single channel cyclic neuromuscular stimulation used for the rehabilitation of moderate arm paresis |
|
| Electromyographic-triggered Multichannel Electrical Stimulation (EMG-MES) | Experimental | EMG-triggered, four channel neuromuscular stimulation used for the rehabilitation of moderate arm paresis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclic single channel neuromuscular stimulation | Device | Cyclic single channel neuromuscular stimulation is used to trigger repetitive muscular contractions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Impact Scale (SIS) subscale Recovery | Scores between 0 and 100, higher meaning a better outcome | pre-intervention to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Impact Scale (SIS), subscale strength | Scores between 0 and 100, higher meaning a better outcome | pre-intervention to 3 weeks |
| Stroke impact scale (SIS) subscale Activities of Daily Living (ADL) / Instrumental Activities of Daily Living (IADL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florian Schwarze, PhD | Contact | +435 77 88 | studies@medel.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KABEG Gailtal-Klinik LKH Hermagor | Recruiting | Hermagor | Carinthia | 9620 | Austria |
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| Electromyogram-triggered 4 channel neuromuscular stimulation | Device | EMG-MES provides biofeedback by using electromyographic signals to trigger muscular contractions |
|
|
Scores between 0 and 100, higher meaning a better outcome
| pre-intervention to 3 weeks |
| Stroke impact scale (SIS) subscale mobility | Scores between 0 and 100, higher meaning a better outcome | pre-intervention to 3 weeks |
| Stroke impact scale (SIS) subscale hand function | Scores between 0 and 100, higher meaning a better outcome | pre-intervention to 3 weeks |
| Fugl-Meyer Assessment - upper extremity (FMA-UE) | Scores between 0 and 100, higher meaning a better outcome | pre-intervention to 3 weeks |
| Action Research Arm Test (ARAT) | Scores between 0 and 57, higher meaning a better outcome | pre-intervention to 3 weeks |
| Safety assessment | Assessment of device related adverse events | through study completion, an average of 15 weeks |
| Ă–. Landeskrankenhaus Hochzirl - Natters, Standort Hochzirl | Recruiting | Zirl | Tyrol | 6170 | Austria |
|
| Kepler Universitätsklinikum Linz | Recruiting | Linz | Upper Austria | 4021 | Austria |
|
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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