为了研究单次注射和连续注射后注射肉毒杆菌毒素A(BoNT-A)对儿童肱三头肌延伸率低下的影响,2-7岁,患有脑瘫和马蹄步态。
随机,分层,平行,两组试验在儿科健康中心进行,并在基线进行评估,预制,postcast和,1-,2-,和6个月的随访。BoNT-A注射到小腿三头肌后一周,应用单个膝下铸型(n=10)或3个连续铸型(n=10),持续3周。主要结果测量是改良Tardieu量表(MTS),次要结局指标为改良Ashworth量表(MAS),GAITRite™,粗大运动功能测量-66(GMFM-66),和儿科残疾评估量表(PEDI)。
时间的显著影响,但不是按时间分组,在MTSR1中发现(P<0.001),MTSR2(P<0.001),MAS(P=0.001),GMFM-66(P=0.002),和PEDI(P<0.001-0.009)。一名接受单一演员阵容的参与者未完成6个月的评估。
使用单一或连续铸造的改进幅度相似。如果这些发现在更大规模的研究中得到证实,由于单一演员阵容对家庭和临床医生更方便,因此建议使用单一演员阵容可能是合适的。
To study the effects of single versus serial casting post-Botulinum toxin A (BoNT-A) injections on hypoextensibility of triceps surae in children, 2-7 years old, with cerebral palsy and equinus gait.
A randomized, stratified, parallel, two-group trial was conducted at a pediatric health center with assessments at baseline, precast, postcast and, 1-, 2-, and 6-month follow-ups. One week following BoNT-A injections into triceps surae muscle, a single below-knee cast (n = 10) or 3 serial casts (n = 10) were applied for 3 weeks. Primary outcome measure was the Modified Tardieu Scale (MTS), secondary outcome measures were Modified Ashworth Scale (MAS), GAITRite™, Gross Motor Function Measure-66 (GMFM-66), and Pediatric Evaluation of Disability Inventory (PEDI).
Significant effects of time, but not group-by-time, were found for MTS R1 (P < 0.001), MTS R2 (P < 0.001), MAS (P = 0.001), GMFM-66 (P = 0.002), and PEDI (P < 0.001-0.009). One participant who received a single cast did not complete the 6-month assessment.
Magnitudes of improvements were similar using single or serial casting. If these findings are corroborated in a larger scale study, the recommendation of a single cast may be appropriate due to its greater convenience for families and clinicians.