We performed a systematic review of the randomized control trials (RCT) to evaluate effectiveness of Botulinum toxin A (BoNTA) injection on walking and Quality of Life (QOL) in post-stroke lower limb spasticity (PSLLS).

We searched PubMed, Web of Science, Embase, CINAHL, ProQuest Thesis and Dissertation checks and Google Scholar, WHO International Clinical Trial Registry Platform, ClinicalTrials.gov, Cochrane, ANZ and EU Clinical Trials Register for RCTs looking at improvement in walking and QOL following injection of BoNTA in PSLLS. The original search was carried out prior to 16 September 2015. We conducted an additional verifying search on CINHAL, EMBASE, and MEDLINE (via PubMed) from 16 September 2015 to 6 June 2017 using the same clauses.

Of 2026 records, we found 107 full text records and 5 RCTs qualifying our criteria. Two independent reviewers assessed methodological validity prior to inclusion in the review. Two studies reported significant improvement in gait velocity (P=0.020 and<0.05, respectively). One study showed significant improvement in 2-min-walking distance (P<0.05). QOL was recorded in one study without any significant improvement. Meta-analysis of reviewed studies could not be performed because of different methods of assessing walking ability, and small sample size with large confidence interval. This review identifies the need for a well-designed RCT to adequately investigate the issues highlighted.

This review could not conclude there was sufficient evidence to support or refute improvement on walking or QOL following BoNTA injection. Reasons for this are discussed and methods for future RCTs are developed.