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

被引:78
作者
Scholtes, Vanessa A.
Dallmeijer, Annet J.
Knol, Dirk L.
Speth, Lucianne A.
Maathuis, Carel G.
Jongerius, Peter H.
Becher, Jules G.
机构
[1] Vrije Univ Amsterdam Med Ctr, Dept Rehabil Med, NL-1007 MB Amsterdam, Netherlands
[2] Vrije Univ Amsterdam Med Ctr, Dept Clin Epidemiol & Biostat, NL-1007 MB Amsterdam, Netherlands
[3] Rehabil Fdn Linburg, Franciscusoord, Valkenburg, Netherlands
[4] Univ Groningen, Univ Med Ctr Groningen, Ctr Rehabil, Groningen, Netherlands
[5] Radboud Univ Nijmegen Med Ctr, Dept Rehabil, Nijmegen, Netherlands
来源
ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION | 2006年 / 87卷 / 12期
关键词
botulinum toxin type A; cerebral palsy; clinical trials; randomized; rehabilitation;
D O I
10.1016/j.apmr.2006.08.342
中图分类号
R49 [康复医学];
学科分类号
100215 [康复医学与理疗学];
摘要
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 +/- 2.1 y). 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.
引用
收藏
页码:1551 / 1558
页数:8
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