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

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Stroke

In brief

Stroke is the leading cause of acquired long-term disability in adults in developed countries. Despite aggressive rehabilitation, lasting upper extremity impairment remains in the majority of stroke survivors. It is hypothesized that enhancing neuroplasticity through the combination of drug therapy and physical therapy could enhance outcomes for stroke survivors. The combination of levodopa and intensive physical therapy shows promise in enhancing the functional motor recovery of stroke patients during the sub-acute and chronic period without reported significant side effects. Robotic-aided training is a promising tool that has the potential to deliver high-intensity, task-oriented, reproducible therapy that can decrease the burden on a therapist. Since the evidence behind dopaminergic potentiation of neuroplasticity and stroke recovery is promising, it is the investigators aim to combine dopaminergic drug therapy with highly intensive robotic-assisted therapy to provide superior upper extremity functional recovery over traditional stroke rehabilitation.

Key facts

Study ID

NCT02346630

Run by

Ross D. Zafonte, MD

People needed

0

Starts

2015-03-01

Expected to finish

2017-03-01

Last updated by the study team

2021-12-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States

Full record on ClinicalTrials.gov

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