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  • Title: 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.
    Author: Scholtes VA, Dallmeijer AJ, Knol DL, Speth LA, Maathuis CG, Jongerius PH, Becher JG.
    Journal: Arch Phys Med Rehabil; 2006 Dec; 87(12):1551-8. PubMed ID: 17141633.
    Abstract:
    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=.02; and 3.5 points, P<.01, respectively) and problem score (1.8 and 1.7 points, P<.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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