Effect of the robotic-assisted gait training device (Welwalk®) plus physiotherapy in improving the ambulatory function in sub-acute hemiplegic stroke patients: assessor-blinded, randomized controlled trial

Abstract

Over the last decades, the effectiveness of robot-assisted gait training devices has been extensively studied. Welwalk® has been developed to support ambulatory functions in stroke patients based on motor learning theory. Objective: To investigate the effects of Welwalk® plus physiotherapy versus physiotherapy alone, in improving ambulatory function in subacute stroke patients with hemiplegia. Methods: The study was an assessor-blinded, randomized controlled trial. Twenty-six subacute stroke patients with hemiplegia were randomized and allocated into either the Welwalk group or control. All patients received 30 training sessions (5 days/week for six weeks) which included standard physiotherapy treatment (60 min) and ambulation training (60 min). In the ambulation training session, the Welwalk group received robotic training (40 min) and ground ambulation training (20 min). The control group received only ground ambulation training (60 min). The outcomes were assessed at the initial session, the end of the 15th and the 30th sessions. Comparisons within group and between the groups were conducted. Results: The Welwalk group showed greater improvements from baseline than control in: (1) the Functional Independence Measure (FIM)-walk score, at the end of the 15th session (P = 0.012), (2) the efficiency of FIM-walk, at the end of the 15th session (P = 0.008), (3) walking distance in the 6-minute walk test (6MWT), at the end of the 15th session (P = 0.018), (4) the Barthel Index for Activities of Daily Living (ADL), at the end of the 30th session (P < 0.001), and (5) gait symmetry ratio, at the end of the 30th session (P = 0.044). Other gait parameters showed the tendencies of improvement in the Welwalk group, but there were no significant differences. Conclusion: Welwalk® plus physiotherapy showed early improvements in walking ability and Barthel ADL index compared with ground level training plus physiotherapy in subacute stroke patients with hemiplegia.