Early non-invasive brain stimulation with modified constraint-induced movement therapy for motor and functional upper limb recovery in stroke patients: Study protocol

Abstract

Introduction

Upper limb motor impairment after a stroke is an important sequela. Constraint-induced movement therapy is a rehabilitation approach that has strong evidence. The incorporation of transcranial direct-current stimulation has been proposed; however, there is a lack of studies that confirm its benefits. The principal aim is to compare the effectiveness of 7 days of active versus sham bi-hemispheric transcranial direct-current stimulation, combined with modified constraint-induced movement therapy, for motor and functional recovery of the hemiparetic upper limb in subacute stroke patients.

Method/design

Randomized, double blind, sham-controlled, parallel group clinical trial in two stroke units. Participants: adults over 18 years, at least 2 days post unihemispheric stroke event, with hemiparesis, and without severe pain, aphasia or cognitive impairment. Intervention: Patients will receive 7 days of continuous therapy and be assigned to one of the treatment groups: active bi-hemispheric transcranial direct-current stimulation or sham bi-hemispheric transcranial direct-current stimulation. Measurement: Evaluations will take place at days 0, 5, 7 and 10, and at 3rd months. The Fugl-Meyer Assessment – Upper Extremity, Wolf Motor Function Test, Functional Independence Measure and Stroke Impact Scale are considered.

Discussion

Modified constraint-induced movement therapy plus transcranial direct-current stimulation in subacute stroke patients with hemiparesis could maximize motor and functional recovery.

Trial registration: ClinicalTrials.gov identifier NCT03452254.