Paresis of the upper extremity due to ischemic or hemorrhagic stroke I61 I63 I64
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - diagnosis of stroke (hemorrhagic or ischemic) - hemiparesis of the upper limb (0 = MRC = 4) - subacute (up to six months after acute event) or chronic (more than 6 months from the acute event) condition - able to sit upright for the duration of the test ( ~1h) - level of cognitive capacity to follow instructions related to the performance exercise
Exclusion criteria
Exclusion criteria: General: - high level of spasticity (MAS: in general > 3, but > 2 for motorized joints) - pain in the affected upper limb (NRS > 4) - severe psychiatric disorder - permanent neurologic symptoms present immediately before stroke - physical conditions that can alter normal biomechanics (e.g. recent sprains or injuries, etc.) - pregnant or nursing women - no written informed consent from the patient or the legal representative - active implantable devices (e.g., pacemaker) - unstable medical condition FES-related: - metal implants within the stimulated area - severe epilepsy or frequent epileptic seizures in the past - cancer - wounds in the application area of the electrodes or measuring equipment - no movement resulting from stimulation Robot-related: - inadequate fitting of the exoskeleton
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility, functionality, and usability of the system in full as well as its modules in a single or integrated modality are the main outcome parameters of this evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes refer to specific aspects of the primary outcomes. - technical specification and reliability (feasibility) - performance, adaptability, and evaluation parameters (functionality) - acceptability, wearability, and user-friendliness (usability) | — |
Countries
Germany, Italy
Contacts
Schön Klinik Bad Aibling SE & Co. KG und Deutsches Schwindel- und Gleichgewichtszentrum