Efficacy of botulinum toxin for poststroke lower limb: a systematic review and meta-analysis

Objective This review aims to conduct a systematic review and meta-analysis on the effectiveness of botulinum toxin in the treatment of spasticity and the improvement of lower limb function in adult stroke survivors, based on randomized clinical trials. Data sources Searches were conducted across multiple databases, including Medline, Scopus, CINAHL, SPORTDiscus, Psychology and Behavioral Sciences Collection, and Cochrane, from inception until September 2025. Review Method This systematic review and meta-analysis was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses recommendations. The meta-analysis was performed using Review Manager 5 software, with mean differences pooled using a random-effects model. Results The analysis included 11 studies, with a total of 1740 adult participants. The results confirm that botulinum toxin is effective in reducing spasticity; however, the benefits on other outcomes, namely gait and balance, were limited and inconsistent. Considerable heterogeneity was also observed in intervention protocols, participant characteristics, dosing regimens, and the selection of target muscle groups. Conclusion It is recommended that future studies prioritize the inclusion of subgroups and medium- and long-term follow-up. Only in this way will it be possible to clarify the true efficacy of botulinum toxin in different patient profiles and to contribute to the optimization of lower limb rehabilitation strategies after stroke.