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.

摘要
本研究旨在提出一项随机临床试验方案，以评估机器人康复对亚急性脑卒中患者功能的改善效果。本随机临床试验方案将在ISCMPA帕维朗·佩雷拉·菲略医院（Pavilhão Pereira Filho）的康复中心开展。
研究将招募40名脑卒中患者，覆盖所有性别，年龄介于18至85岁，且存在偏瘫或肌肉无力（医学研究理事会（Medical Research Council，MRC）评分<48分），所有受试者将被随机分配至对照组或干预组。
干预组在接受常规物理治疗的基础上，还将使用Erigo®设备开展机器人康复训练；对照组则仅接受常规物理治疗，训练动作与机器人辅助训练的动作模式保持一致。
干预将在患者住院期间每日进行，出院后每周3次，总计约18个疗程。
本研究的主要结局指标为患者功能状态，将采用Fugl-Meyer评估量表（Fugl-Meyer Scale）进行测评。次要结局指标包括：肌肉力量（MRC评分及最大重复次数测试）、痉挛状态（改良Ashworth痉挛量表）、股四头肌肌肉结构及回声特性（超声检测）、活动能力（计时起立行走试验（timed up go test））、残疾与依赖程度（Rankin量表及功能独立性评定量表（Functional Independence Measure，FIM））、生活质量（EQ-5D问卷）、心肺相关影响（生命体征监测）、住院时长（单位：天）以及死亡率（死亡例数）。
两组受试者将在干预前、第10个疗程结束后以及治疗满6周或完成全部18个疗程时接受测评。