Robotic rehabilitation in stroke patients: a protocol of a randomized clinical trial

ABSTRACT The aim of this study was to propose a randomized clinical trial protocol to evaluate the effect of robotic rehabilitation on the functionality of patients with subacute stroke. This is a protocol of a randomized clinical trial that will be developed at hospital and rehabilitation center of Pavilhão Pereira Filho of ISCMPA. We will recruit 40 patients with stroke, all genders, aged between 18 and 85 years and showing hemiparesis or muscle weakness (Medical Research Council- MRC<48 points), who will be randomized to a control group or intervention group. The intervention group-besides conventional physical therapy-will perform robotic rehabilitation using Erigo® equipment. The control group, in its turn, will receive conventional physical therapy executing exercises with similar movements to those performed on the robot. Interventions will occur every day during hospital phase and three times/week after discharge, totaling approximately 18 sessions. Functioning will be considered the primary outcome of the study and will be assessed using the Fugl-Meyer scale. As secondary outcomes, we considered: muscle strength (MRC and maximum repetition test); spasticity (modified Ashworth scale); quadriceps muscle architecture and echogenicity (ultrasound); mobility (timed up go test); degree of disability and dependence (Rankin scale and Functional Independence Measure); quality of life (EQ-5D questionnaire); cardiorespiratory repercussions (monitoring vital signs); length of hospital stay (in days); and mortality (number of deaths). The groups will be evaluated before the interventions, after the 10th session, and at the end of six weeks of treatment or 18 sessions.