Efficacy of physical therapy associated with botulinum toxin type A on functional performance in post-stroke spasticity: A randomized, double-blinded, placebo-controlled trial

Abstract

The aim was to investigate if botulinum toxin type A (BTx-A) associated with physical therapy is superior to physical therapy alone in post stroke spasticity. A randomized, double-blinded controlled trial was performed in a rehabilitation unit on Northeastern, Brazil. Patients with post stroke spasticity were enrolled either to BTx-A injections and a pre-defined program of physical therapy or saline injections plus physical therapy. Primary endpoint was functional performance evaluated through time up and go test, six minutes walking test and Fugl-Meyer scale for upper limb. Secondary endpoint was spasticity improvement. Confidence interval was considered at 95%. Although there was a significant decrease in upper limbs flexor tonus (P<0.05) in the BTx-A group, there was no difference regarding functional performance after 9 months of treatment. When analyzing gait speed and performance, both groups showed a significant improvement in the third month of treatment, however it was not sustained over time. Although BTx-A shows superiority to improve muscle tone, physical therapy is the cornerstone to improve function in the upper limbs of post stroke patients.

Botulinum Toxin Therapy Combined with Rehabilitation for Stroke: A Systematic Review of Effect on Motor Function

“…Twenty-six studies were reviewed, including 1307 patients. There was a significant effect observed in 23 studies in the intervention group on spasticity [18][19][20][21][22][24][25][26][27][28][29][30][31][32][34][35][36][37][40][41][42][43][44][45]. In regard to upper limb motor function, 11 of 14 cases showed improvement, but two studies showed significant differences in comparison with the control group [19][20][21]25,[27][28][29][30][31][32][33][34]37,42,45].…”

“…In addition, the motor activity log (MAL) also reported that there was a significant improvement after three or six months. On the other hand, nine of 14 studies showed improvement in upper limb function by the intervention, but there was no significant difference or comparison with the control group [19,20,[28][29][30][31][32]37,42]. Wolf et al (2012) reported that there were no group-by-time interactions for changes in the Wolf Motor Function Test and no treatment difference, although the intervention group could complete more tasks governing proximal joint motions [29].…”

“…Therefore, these studies were regarded as one article [30,31,38,39]. Prazeres A et al 2018 [19] I:15(BoNT-A, CIMT) C:14(BoNT-A, convention rehabilitation) 24:5 I:58.7(9.9) C:61.5(9.4) I:2.9(1.5) C:2.9(1.3) years…”

“…As mentioned above, in two studies, multiple doses were administered in compliance with the dosing interval [30,31,35]. For some studies, although there was mention of botulinum toxin, there was no mention of the dose volume or location or both (30.7%) [19,[21][22][23][30][31][32]40,42].…”

“…Johnson et al (2002Johnson et al ( , 2004 reported that the physiological cost index (PCI) decreased slightly in the intervention group with improvement in lower extremity function, which was not observed in the control group (rehabilitation only) [38,39]. Though five studies showed improvement in motor function by intervention, there was no significant difference compared with control group or there was no comparison between groups [18,19,26,35,40]. Interestingly, Burbaud et al (1996) focused not only on changes in lower limb motor function but also on changes in aids.…”