Effects of robot-assisted gait training in chronic stroke patients treated by botulinum toxin-a: A pivotal study

Abstract

Objective: To investigate combined effects of robot-assisted training (RAT) and physical therapy versus physical therapy only on balance and gait function of chronic stroke patients after botulinum toxin-A (BoNT-A) treatment.

Methods: Forty-eight chronic stroke patients, received BoNT-A treatment for lower extremity spastic muscles, were randomly assigned to RAT (n = 32) and control (n = 16) groups in a 2:1 ratio. RAT group received 30 min of RAT (RoboGait®) plus 60 min of physical therapy, whereas controls received 90 min of physical therapy for 3 weeks during weekdays. Outcome assessments were measured at baseline and post-treatment Weeks 6 and 12. Spasticity was assessed by Modified Ashworth Scale and Tardieu Scale. Balance and gait functions were assessed by Berg Balance Scale, Timed Up and Go test, and Rivermead Visual Gait Assessment.

Results: Demographic and baseline characteristics were similar in both groups (p > .05) for all parameters. Significant improvements were determined in both RAT and control groups regarding spasticity, balance, and gait functions after treatment. However, at post-treatment Weeks 6 and 12, change from baseline Timed Up and Go test (p = .003 and p = .002, respectively), Berg Balance Scale (p = .001 and p < .001, respectively), and Rivermead Visual Gait Assessment (p < .001 and p < .001, respectively) were significantly higher in RAT group than those of the control group.

Conclusion: Integrated treatment with RAT and physical therapy might provide additional benefits in chronic stroke patients whom spasticity was treated by BoNT-A.

Keywords: botulinum toxin-a; gait; robotics; stroke.