Robot-Assisted Gait Therapy in the Subacute Phase of Ischemic Stroke: A Randomized Controlled Trial

Abstract Background and Objectives: Robot-assisted gait training (RAGT) constitutes a modern neurorehabilitation approach. However, limited data are available regarding the efficacy of RAGT when combined with conventional rehabilitation in the early subacute phase of stroke. This pilot study assessed the additive impact of protocol-defined RAGT on functional ambulation categories (FACs), walking abilities, and balance. Methods: This randomized controlled trial used a 1:1 Prospective Randomized Open Blinded End-point design (NCT04910217), comparing two groups: conventional rehabilitation and the RAGT group. All participants received protocol-defined conventional rehabilitation (15 sessions over 3 weeks). The RAGT group underwent additional sessions using the Lokomat Pro FreeD (15 sessions over 3 weeks). FAC, 10-meter Walk Test (10MWT), Timed Up and Go (TUG), and Berg Balance Scale (BBS) were assessed at 3 weeks and 3 months after randomization. In addition, the modified Rankin Scale was evaluated. Results: Among 184 patients screened between June 1, 2020, and November 30, 2023, 42 were included (19 in the RAGT group and 23 in the conventional group). The median time from stroke to randomization was 13 days (interquartile range IQR: 11–16), and the median age was 67 years (IQR: 58–71). Both groups demonstrated improvements in FACs. Significantly, patients in the RAGT group showed better results in the endpoint of FAC improvement by 2 or more points ( P = 0.044). Progress in TUG ( P = 0.034) and BBS ( P = 0.049) during the study period was significantly more favorable in the RAGT group. Conclusions: The addition of RAGT to conventional rehabilitation in the subacute phase of stroke exhibited positive effects on improving gait, walking, and balance. Trial registration number: NCT04910217