Stroke Clinical Trial
Official title:
Effects of Home-based Neurostimulation Associated With Motor Training in Chronic Stroke Patients
Objective: To investigate effects of home-based somatosensory stimulation associated with motor training on improvement in performance of the paretic upper extremity in patients in the chronic phase after stroke.
Design: Double-blind, randomized, controlled clinical trial. Setting: Home-based
rehabilitation. Subjects: Patients in the chronic phase (> 6 months) after stroke.
Interventions: Patients will be randomized to an active and a control group. In both groups,
treatments will be performed at home, daily, over four weeks. Patients in the active group
will be instructed to use a device that provides somatosensory stimulation in the form of
electrical stimulation of the median nerve for two hours. Patients in the control group will
also be instructed to use the device for two hours, and sham stimulation will be
administered. In both groups, patients will be instructed to train activities with the
paretic hand immediately after nerve stimulation.
Main measures: The primary outcome will be improvement in performance of the paretic hand
evaluated by the Jebsen-Taylor test at end of treatment and four months after end of
treatment, compared to baseline. Secondary outcomes were: 1) Compliance with the
interventions, assessed through a daily written log, and oral reports of the patients; 2)
safety profile of the interventions.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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