Table 3.
Comparison of five randomized controlled trials of botulinum toxin in post-stroke lower limb spasticity
| Study characteristics | Tao W et al. | Kaji R et al. | Johnson C et al. | Pittock S et al. | Burbaud P et al. |
|---|---|---|---|---|---|
| Age group (years) | 18–80 | 22–80 | 44–78 | 51–69 | 14–72 |
| Primary outcome measure | Gait analysis Spasticity |
MAS ankle score | Gait velocity | 2 min Walking distance |
Subjective rating of treatment efficacy |
| Sample size Study length Follow-up |
n = 23 12 weeks 4 and 8 weeks |
n = 120 12 weeks 4, 6, 8, and 12 weeks |
n = 21 12 weeks 2, 4, 8, and 12 weeks |
n = 234 12 weeks 4, 8, and 12 weeks |
n = 23 4 months 0, 4, 12, and 16 weeks |
| Power calculation | None | Yes | None | Yes | None |
| Inclusion criteria | Post-stroke Ambulatory status not specified |
Post-stroke Ambulatory status not specified |
Post-stroke Patients were ambulatory |
Post-stroke All patients could walk > 5 m |
Post-stroke and trauma Non-homogenous Two patients could not ambulate |
| Intervention | EMG guided, 200 botox, gastrocnemius, soleus, tibialis | EMG guided, 300 botox, gastrocnemius, soleus, tibialis posterior | EMG guided, 1200 Dysport, gastrocnemius soleus, tibialis posterior | No EMG 500–1500 Dysport Gastrocnemius and soleus |
EMG guided, 1000 Dysport, gastrocnemius, posterior, flexor digitorum longus |
| Statistical methods | Mean (SD), t tests, chi-square, Kruskal-Wallis | Mean (SD), t tests, area under curve, Wilcoxon | Mean (SD), ANCOVA, graphic plots | Mean (SD), one-way ANCOVA, Dunets test, Rank test | Mann-Whitney |
| Study results | Gait speed ⇧ Sig MAS ⇩Sig FMA ⇧ Sig MBI ⇧ Sig |
Gait speed ⇨ N.S MAS ⇩ Sig CGI ⇨ N.S PRS ⇨ N.S |
Gait speed ⇧ sig MAS ⇩ Sig, RMA ⇩ Sig, SF-36 ⇨ N.S |
2-min walk ⇨ N.S Step length ⇨N.S Aids ⇨ N.S. Subjective ⇨ N.S MAS ⇩ Sig, RMA ⇨ N.S |
MAS ⇩ Sig, FMA ⇩ sig, Spasticity ⇨ N.S |
| Secondary outcome measures | MAS, FMA, MBI, sEMG | Physician Rating Scale of gait, gait velocity, CGI, safety | MAS, PCI, RMA, SF-36 | MAS, step length, RMA, active and passive range of ankle movement | MAS, FMA, gait velocity |
| Concurrent therapy | Standardized | Not standardized | Standardized | 38% received therapy | Not standardized |
MAS Modified Ashworth Scale, FMA Fugl-Meyer Assessment, MBI Modified Barthel Index, sEMG surface electromyograph, CGI Clinical Global Impression, RMA Rivermead Motor Assessment, EMG electromyograph, Sig significant, N.S not significant