Hugh Williamson Gait Laboratory, Royal Children's Hospital, Melbourne, 50 Flemington Road, Parkville, Victoria 3052, Australia.
J Bone Joint Surg Am. 2011 Mar 2;93(5):451-60. doi: 10.2106/JBJS.J.00410.
Single-event multilevel surgery is considered the standard of care to improve gait and functioning of children with spastic diplegic cerebral palsy. However, the evidence base is limited. This pilot study is the first randomized controlled trial of single-event multilevel surgery, to our knowledge.
Nineteen children (twelve boys and seven girls with a mean age of nine years and eight months) with spastic diplegia were enrolled. Eleven children were randomized to the surgical group and eight, to the control group. The control group underwent a program of progressive resistance strength training. The randomized phase of the trial concluded at twelve months. The control group then exited the study and progressed to surgery, whereas the surgical group continued to be followed in a prospective cohort study. The primary outcome measures were the Gait Profile Score (GPS) and the Gillette Gait Index (GGI). Secondary outcome measures were gross motor function (Gross Motor Function Measure-66 [GMFM-66]), functional mobility (Functional Mobility Scale [FMS]), time spent in the upright position, and health-related quality of life (Child Health Questionnaire [CHQ]).
A total of eighty-five surgical procedures were performed, with a mean of eight procedures per child (standard deviation, four). The surgical group had a 34% improvement in the GPS and a 57% improvement in the GGI at twelve months. The control group had a small nonsignificant deterioration in both indices. The between-group differences for the change in the GPS (-5.5; 95% confidence interval, -7.6 to -3.4) and the GGI (-218; 95% confidence interval, -299 to -136) were highly significant. The differences between the groups with regard to the secondary outcome measures were not significant at twelve months. At twenty-four months after surgery, there was a 4.9% increase in the GMFM-66 score and improvements in the FMS score, time spent in the upright position, and the physical functioning domain of the CHQ in the surgical group.
This study provides Level-II evidence that single-event multilevel surgery improves the gait of children with spastic diplegic cerebral palsy twelve months after surgery. Improvements in other domains, including gross motor function and quality of life, were not observed until twenty-four months after surgery.
单阶段多水平手术被认为是改善痉挛性双瘫脑瘫患儿步态和功能的标准治疗方法。然而，证据基础有限。据我们所知，这是第一项关于单阶段多水平手术的随机对照试验。
共纳入 19 名痉挛性双瘫患儿（男 12 名，女 7 名，平均年龄 9 岁 8 个月）。11 名患儿被随机分为手术组，8 名患儿分为对照组。对照组接受渐进式抗阻力量训练。试验的随机阶段在 12 个月结束。对照组随后退出研究并进行手术，而手术组则继续在前瞻性队列研究中进行随访。主要结局指标为步态分析评分（GPS）和吉尔伯特步态指数（GGI）。次要结局指标为粗大运动功能（粗大运动功能测量-66[GMFM-66]）、功能性移动能力（功能性移动能力量表[FMS]）、直立时间和健康相关生活质量（儿童健康问卷[CHQ]）。
共进行了 85 次手术，平均每个患儿 8 次（标准差为 4 次）。手术组 GPS 改善 34%，GGI 改善 57%，12 个月时。对照组在这两个指标上都有轻微的非显著性恶化。GPS（-5.5；95%置信区间，-7.6 至-3.4）和 GGI（-218；95%置信区间，-299 至-136）变化的组间差异具有高度显著性。12 个月时，两组间的次要结局指标差异无统计学意义。手术后 24 个月，手术组 GMFM-66 评分增加 4.9%，FMS 评分、直立时间和 CHQ 身体功能域改善。
本研究提供了 II 级证据，表明单阶段多水平手术可改善痉挛性双瘫脑瘫患儿术后 12 个月的步态。直到术后 24 个月，才观察到其他领域（包括粗大运动功能和生活质量）的改善。
