Effects of the Robot-Assisted Gait Training Device Plus Physiotherapy in Improving Ambulatory Functions in Patients With Subacute Stroke With Hemiplegia: An Assessor-Blinded, Randomized Controlled Trial

Objective: To investigate the effects of the robot-assisted gait training (RAGT) device plus physiotherapy vs physiotherapy alone in improving ambulatory functions in patients with subacute stroke with hemiplegia. Design: A prospective, assessor-blinded, randomized controlled trial. Setting: Patients with subacute stroke with hemiplegia admitted at the Rehabilitation Center. Participants: Twenty-six patients with subacute stroke with hemiplegia (N=26). Intervention: All patients received 30 training sessions (5 d/wk for 6 wk), which included conventional physiotherapy training (60 minutes) and ambulation training (60 minutes). In the ambulation training session, the RAGT device group received robotic training (40 minutes) and ground ambulation training (20 minutes). The control group received only ground ambulation training (60 minutes). The outcomes were assessed at the initial session and at the end of the 15^th and 30^th sessions. Comparisons within groups and between groups were conducted. Main Outcome Measures: Primary outcome variables were the FIM-walk score and the efficacy of FIM-walk. Results: The RAGT device group showed greater improvements from baseline than control in (1) the FIM-walk score at the end of the 15^th session (P=.012), (2) the efficacy of FIM-walk at the end of the 15^th session (P=.008), (3) walking distance in the 6-minute walk test at the end of the 15^th session (P=.018), (4) the Barthel Index for Activities of Daily Living (ADL) at the end of the 30^th session (P<.001), and (5) gait symmetry ratio at the end of the 30^th session (P=.044). Other gait parameters showed tendencies of improvement in the RAGT device group, but there were no significant differences. Conclusions: RAGT devices plus physiotherapy showed early improvements in walking ability and Barthel ADL index compared with the ground level training plus physiotherapy in patients with subacute stroke with hemiplegia.