Combining Robotic-Assisted Therapy and Pharmacotherapy in Post-Stroke Rehabilitation

Withdrawn

Phase 4 Results N/A

Eligibility Criteria

Inclusion Criteria

- Male and female, community dwelling, age 18-85.
- First episode of stroke.
- Diagnosis of chronic ischemic stroke at least six months before study enrollment resulting in objective motor upper-extremity impairment as demonstrated during physical/neurological examination.
- Score of 15-55 out of 66 on the arm motor Fugl-Meyer scale.
- The ability to extend ≥ 10 degrees at metacarpophalangeal and interphalangeal joint of all digits.
- Signed written informed consent.

Exclusion Criteria

- Intracranial hemorrhages.
- Pregnancy, planning to become pregnant or breast-feeding.
- History of seizures within the previous six months.
- Previous residual motor deficit in the affected side.
- Treatment with Botox injections in the affected arm in the previous 6 months.
- Cognitive impairment that may interfere with understanding instructions for motor tasks and assessment tools.
- Other major neurologic disorder (Parkinson's disease).
- Major depression defined by the Patient Health Questionnaire, other major psychiatric pathology, dementia, agitation (defined as a score of >21 on the Agitated Behavior Scale) or another uncooperative behavior.
- Inability to operate the Armeo system (which will be assessed during the calibration process). Subjects must have sufficient range of movement to enable calibration of the virtual workspace.
- Contraindications for Levodopa/ Carbidopa:
- Hypersensitivity to levodopa, carbidopa or any component of the formulation.
- Use of monoamine oxidase inhibitors (MAOIs) within prior 14 days. Treatment with tricyclic antidepressants, antipsychotics, sapropterin, selective serotonin reuptake inhibitors (SSRIs), pimozide, benzodiazepines, amantadine, methylphenidate, dopamine-agonists or neuroleptic drugs when inclusion or the month before.
- Narrow-angle glaucoma.
- Suspicious, undiagnosed skin lesions or a history of melanoma.
- Presence of metallic hardware in close contact to the discharging coil (cochlear implants, aneurism clips, brain implants, internal pulse generator, medication pumps).
- Contemporary participation in another interventional trial focused on the impaired arm recovery.
- Drug or alcohol abuse in the last 3 years.
- A terminal medical diagnosis with survival < 1 year.
- End-stage or uncompensated hepatic, cardiovascular, cerebrovascular, endocrine, renal, digestive, hematologic or pulmonary disease. Active ulcer disease.