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Randomized Controlled Trial
. 2006 Dec;87(12):1551-8.
doi: 10.1016/j.apmr.2006.08.342.

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

Vanessa A Scholtes  1 , Annet J Dallmeijer, Dirk L Knol, Lucianne A Speth, Carel G Maathuis, Peter H Jongerius, Jules G Becher
Affiliations
Randomized Controlled Trial

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

Vanessa A Scholtes et al. Arch Phys Med Rehabil. 2006 Dec.

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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Comment in

  • Botulinum toxin type A and other factors.
    Dai AI. Dai AI. Arch Phys Med Rehabil. 2007 Apr;88(4):541-2; author reply 542. doi: 10.1016/j.apmr.2007.02.017. Arch Phys Med Rehabil. 2007. PMID: 17398260 No abstract available.

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