Efficacy and safety of very early mobilization after thrombolysis in acute ischemic stroke: a randomized clinical trial

BACKGROUND: Stroke has a deleterious impact on human health due to its high incidence, degree of disabling sequelae and mortality, constituting one of the main causes of death and disability worldwide. OBJECTIVES: This study aimed to assess the efficacy and safety of very early mobilization (VEMG) after thrombolysis in functional recovery in patients with acute ischemic stroke. METHODS: The present study was an open, prospective, randomized study, with no blinded outcome, carried out in the stroke unit of a tertiary referral hospital located in Salvador-Bahia, Brazil. The primary outcome was the level of functional independence. Secondary outcomes were functional mobility, balance, complications within 7 days of hospitalization and 90 days after hospital discharge, and length of stay. OUTCOMES: A total of 104 patients with ischemic stroke who received thrombolytic treatment between August 2020 and July 2021 were prospectively recruited to the study. Of these, 51 patients received VEMG within 24 h of the ictus and another 53 patients receiving usual care (UCG) with mobilization 24 h after the ictus. When compared to the usual care, the VEMG group was not associated with a significant reduction in the risk of the primary outcome (relative risk [95% confidence intervals]: 0.74 [0.339–1.607]) or any of the secondary outcomes. CONCLUSION: In this study, the strategy of early mobilization after thrombolysis in ischemic stroke was safe, but without evidence of short-term benefit. Brazilian Registry of Clinical Trials under the registry (registry number: RBR-8bgcs3). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00415-022-11411-5.