Abstract
Post-stroke spasticity impedes patients’ rehabilitation progress. Contradictory evidence has been reported in using Botulinum Neurotoxin type A (BoNT-A) to manage post-stroke lower extremity spasticity (PLES); furthermore, an optimum dose of BoNT-A for PLES has not yet been established. Therefore, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to identify the efficacy and optimal dose of BoNT-A on PLES. "Meta" and "Metafor" packages in R were used to analyze the data. Hedges’ g statistic and random effect model were used to calculate and pool effect sizes. Twelve RCTs met the eligibility criteria. Muscle tone significantly improved in week four, week eight, and maintained to week twelve after BoNT-A injection. Improvements in functional outcomes were found, some inconsistencies among included studies were noticed. Dosage analysis from eight studies using Botox® and three studies using Dysport® indicated that the optimum dose for the commonest pattern of PLES (spastic plantar flexors) is medium-dose (approximately 300U Botox® or 1000 U Dysport®). BoNT-A should be regarded as part of a rehabilitation program for PLES. Furthermore, an optimal rehabilitation program combined with BoNT-A management needs to be established. Further studies should also focus on functional improvement by BoNT-A management in the early stage of stroke.
Highlights
Post-stroke lower extremity spasticity (PLES) has been being a challenging issue in the rehabilitation field, with the prevalence ranging from 17% to 42.6% [1]
After reviewing titles and abstracts, 309 apparent irrelevant papers were removed. Of these 36 remainders, we excluded 24 studies for several reasons: protocol with ongoing studies (n = 6), non-randomized controlled trials (RCTs) design (n = 5), other conjunctive therapies combined with Botulinum Neurotoxin type A (BoNT-A) injection (n = 7), comparison of BoNT-A and other treatments (2), upper limb (n = 2), injection-guiding techniques comparison (n = 1), secondary analysis (n = 1)
In the other multicenter randomized, double-blind study conducted in France, 40 chronic stroke subjects were randomized to receive either placebo or a maximum of 300 U Botox®(mean 227 U) flexibly based on the physician’s adjustment for each patient, the results of this study showed that patients who received Botox significantly improved in spasticity but in balancing ability [22]
Summary
Post-stroke lower extremity spasticity (PLES) has been being a challenging issue in the rehabilitation field, with the prevalence ranging from 17% to 42.6% [1]. Albeit a few positive influences of spasticity have been reported, it is irrefutable that this upper motor neuron syndrome’s component has clinically negative influences on health-related quality of life [2]. PLES was consistently demonstrated to be negatively correlated with ambulation, functional capacity, and balance ability [3,4,5,6]. Inappropriate distribution of pressure during weight-bearing is attributable to foot pain, callus formation, and soft tissue breakdown [7]. While hip flexors and knee extensors strength predominantly affect gait speed, the degree of ankle plantar flexors spasticity primarily influenced the temporospatial gait performance of hemiplegic patients [8].
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