BACKGROUND: Stroke is the most common cause of disability in western countries. It can lead to loss of mobility, capability to walk and ultimately loss of independence in activities of daily living (ADL). Several rehabilitative approaches have been proposed in these years. Robot-assisted gait rehabilitation (RAGT) plays a crucial role to perform a repetitive, intensive, and task-oriented treatment in stroke survivors. However, there are still few data on its role in subacute stroke patients. AIM: To assess the efficacy of RAGT for gait recovery in subacute stroke survivors. DESIGN: Systematic review with meta-analysis. SETTING: Rehabilitation units. POPULATION: Subacute stroke patients. METHODS: PubMed, Scopus, Web of Science, CENTRAL, and PEDro were systematically searched until 18th January 2021 to identify randomized controlled trials (RCTs) presenting: stroke survivors in subacute phase (<= 6 months) as participants; exoskeleton robots devices as intervention; conventional rehabilitation as a comparator; gait assessment, through qualitative scales, quantitative gait scales or quantitative parameters, as outcome measures. We also performed a meta-analysis of the mean difference in the functional ambulation category (FAC) via the random effect method. RESULTS: Out of 3,188 records, 14 RCTs were analyzed in this systematic review. The 14 studies have been published in the last 14 years (from 2006 to 2021) and included 576 stroke survivors, of which 306 received RAGT, and 270 underwent conventional rehabilitation. Lokomat robotic system was the most investigated robotic exoskeleton by the RCTs included (n = 9), albeit the meta-analysis demonstrated a non-significant difference of -0.09 in FAC (95% CI -0.22 to 0.03) between Lokomat and conventional therapy. According to the PEDro scale, 11 (78.5%) were classified as good-quality studies, two as fair-quality studies (14.3%), and one as poor-quality study (7.1%). CONCLUSIONS: Taken together, these findings showed that RAGT might have a potential role in gait recovery in subacute stroke survivors. However, further RCTs comparing the efficacy of RAGT with conventional physical therapy are still warranted in the neurorehabilitation field.

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