Assessment of the Efficacy of ReoGo-J Robotic Training Against Other Rehabilitation Therapies for Upper-Limb Hemiplegia After Stroke: Protocol for a Randomized Controlled Trial

Abstract

Background: Stroke patients experience chronic hemiparesis in their upper extremities leaving negative effects on quality of life. Robotic therapy is one method to recover arm function, but its research is still in its infancy. Research questions of this study is to investigate how to maximize the benefit of robotic therapy using ReoGo-J for arm hemiplegia in chronic stroke patients.Methods: Design of this study is a multi-center parallel group trial following the prospective, randomized, open-label, blinded endpoint (PROBE) study model. Participants and setting will be 120 chronic stroke patients (over 6 months post-stroke) will be randomly allocated to three different rehabilitation protocols. In this study, the control group will receive 20 min of standard rehabilitation (conventional occupational therapy) and 40 min of self-training (i.e., sanding, placing and stretching). The robotic therapy group will receive 20 min of standard rehabilitation and 40 min of robotic therapy using ReoGo®-J device. The combined therapy group will receive 40 min of robotic therapy and 20 min of constraint-induced movement therapy (protocol to improve upper-limb use in ADL suggests). This study employs the Fugl-Meyer Assessment upper-limb score (primary outcome), other arm function measures and the Stroke Impact Scale score will be measured at baseline, 5 and 10 weeks of the treatment phase. In analysis of this study, we use the mixed effects model for repeated measures to compare changes in outcomes between groups at 5 and 10 Weeks. The registration number of this study is UMIN000022509.Conclusions: This study is a feasible, multi-site randomized controlled trial to examine our hypothesis that combined training protocol could maximize the benefit of robotic therapy and best effective therapeutic strategy for patients with upper-limb hemiparesis.

Effects of Acupuncture Combined with Biofeedback Therapy on Limb Motor Rehabilitation in Patients with Acute Stroke: Systematic Review and Meta-Analysis

“…Brunnstrom divided the recovery of motor function of hemiplegic patients into six stages: relaxation stage, muscle tone and combined exercise stage, muscle spasm stage, common movement and primitive posture reflex stage, separated movement stage, spasm basically disappeared stage, and coordinated movement basically normal stage [ 28 ]. The recovery of motor function of hemiplegic patients is actually to break the abnormal movement pattern under the low central control and establish a normal movement pattern in the later stage of recovery [ 29 ].…”

The Outcomes of Robotic Rehabilitation Assisted Devices Following Spinal Cord Injury and the Prevention of Secondary Associated Complications

“…It also enables actions at the wrist, elbow (flexion/extension), and shoulder (i.e., flexion/extension, abduction/adduction, internal/external rotation). Furthermore, ReoGo was primarily utilized for stroke recovery of the upper limbs [ 72 ]. These upper extremity robotic devices are still being studied in patients with SCIs, and the technology improves yearly.…”

Robot-Assisted Training as Self-Training for Upper-Limb Hemiplegia in Chronic Stroke: A Randomized Controlled Trial

“…Any patient could be deemed ineligible by the investigator (if patients became unable to start or continue participation in the study [eg, failed to attend study visit, withdrew informed consent, experienced adverse events or complications, regained arm function and refused further rehabilitation, or any other event judged by the investigator to warrant withdrawal]). 18…”