The Combined Effect of Lower-Limb Multilevel Botulinum Toxin Type A and Comprehensive Rehabilitation on Mobility in Children With Cerebral Palsy: A Randomized Clinical Trial

Schematic design of study and study assessments. The duration of baseline for children in the control group varied from 18 to 30 weeks. NOTE. Negative values for number of weeks before intervention; positive values for number of weeks after intervention. Thick black line in the intervention group analysis charts demarks multilevel BTX-A injections and comprehensive rehabilitation. *One child in the intervention group and 3 in the control group withdrew from the study after week 24 follow-up. They subsequently underwent myotenotomy of the gastrocnemius muscle, orthopedic surgery, or selective dorsal rhizotomy, on recommendation of the pediatric physiatrist (JGB).

Estimated marginal means and standard errors of (A) GMFM-66, (B) energy cost (only presented for subgroup), and (C) problem scores on different study visits (6-wk intervals): trial analysis for intervention group (n=23) and control group (n=23). NOTE. Energy cost is in J·kg⁻¹·m⁻¹. Numbers on the x axis represent, for the intervention and control group, respectively: 1 (week −6, week −30); 2 (week −1, week −24); 3 (week +6, week −18); 4 (week +12, week −12); 5 (no assessment, week −6); and 6 (week +24, week −1). A dashed line demarks the multilevel BTX-A injections and comprehensive rehabilitation in the intervention group. *Significant difference in change between the intervention group and the control group, corrected for baseline differences (P<.05).

Estimated marginal means and standard errors of (A) GMFM-66, (B) energy cost (only presented for subgroup), and (C) problem scores on different study visits (6-wk intervals): before-after analysis in the total group (n=46) for subgroups based on GMFCS. NOTE. Energy cost is in J·kg⁻¹·m⁻¹. Numbers on the x axis represent: 1 (week −6); 2 (week −1); 3 (week +6); 4 (week +12); 5 (no assessment); 6 (week +24); 7 to 9 (no assessment); and 10 (week +48). A dashed line demarks multilevel BTX-A injections and comprehensive rehabilitation in the total group (n=46). *Significant difference in change between the GMFCS levels, corrected for baseline differences (P<.05).