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
Abstract
Scholtes VA, Dallmeijer AJ, Knol DL, Speth LA, Maathuis CG, Jongerius PH, Becher JG. 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.
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.
aDepartment of Rehabilitation Medicine, VU University Medical Center, Amsterdam, The Netherlands
bClinical Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands
cRehabilitation Foundation Linburg, Franciscusoord, Valkenburg, The Netherlands
dCenter for Rehabilitation, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
eDepartment of Rehabilitation, University Medical Center St. Radboud, Nijmegen, The Netherlands.
Reprint requests to Vanessa A. Scholtes, MSc, Dept of Rehabilitation Medicine, VU University Medical Center, PO Box 7057, 1007 MB Amsterdam, The Netherlands.
Supported by the Johanna Kinderfonds (grant no. 2000/0145); Prinses Beatrix Fonds (grant no. PGO01-134), and Stichting Bio-Kinderrevalidatie, The Netherlands. Study medication was self-supported by the Department of Rehabilitation Medicine, VU University Medical Center.
No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the author(s) or upon any organization with which the author(s) is/are associated.
ABSTRACT