OBJECTIVE: To evaluate the combined effect on mobility of treatment with multilevel Botulinum toxin type A (BTX-A) and comprehensive rehabilitation in children with cerebral palsy (CP). DESIGN: Randomized clinical trial using a multiple baseline design. The intervention group was treated 6 weeks after randomization. The control group was treated after a longer period of 18 to 30 weeks. Repeated measurements in both groups were continued throughout the process, before and up to 48 weeks after treatment. SETTING: Four departments of rehabilitation medicine in The Netherlands. PARTICIPANTS: Forty-six children with spastic CP (mean age +/- standard deviation, 8.0 +/- 2.1y). INTERVENTION: The intervention group (n = 23) was treated with multilevel BTX-A and comprehensive rehabilitation. Control group subjects (n = 23) continued with their usual physical therapy (PT) for 18 to 30 weeks, and then also received multilevel BTX-A and comprehensive rehabilitation. MAIN OUTCOME MEASURES: The primary outcome measure was the Gross Motor Function Measure (GMFM-66); the secondary measures were problem score and energy cost. RESULTS: The treatment effect during the first 24 weeks of follow-up in the intervention group was compared with the effect of usual PT in the control group. Treatment with multilevel BTX-A and comprehensive rehabilitation provided a significantly greater improvement at 12 and 24 weeks in both the GMFM-66 (2.1 points, p = 0.02; and 3.5 points, p < 0.01, respectively) and problem score (1.8 and 1.7 points, p < 0.001, respectively) compared with usual PT. No difference was found in energy cost. Before-after analysis of the total group (n = 46) showed a significant long-term improvement (48wk) on all outcome measures. CONCLUSIONS: Treatment with multilevel BTX-A and comprehensive rehabilitation significantly improves mobility as measured by the GMFM-66 and problem score in children with CP.

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