Post Graduate Program in Reabilitation Sciences, Nove de Julho University, UNINOVE, Sao Paulo, Brazil.
BMC Pediatr. 2012 May 16;12:53. doi: 10.1186/1471-2431-12-53.
The use of botulinum toxin A (BT-A) for the treatment of lower limb spasticity is common in children with cerebral palsy (CP). Following the administration of BT-A, physical therapy plays a fundamental role in potentiating the functionality of the child. The balance deficit found in children with CP is mainly caused by muscle imbalance (spastic agonist and weak antagonist). Neuromuscular electrical stimulation (NMES) is a promising therapeutic modality for muscle strengthening in this population. The aim of the present study is to describe a protocol for a study aimed at analyzing the effects of NMES on dorsiflexors combined with physical therapy on static and functional balance in children with CP submitted to BT- A.
METHODS/DESIGN: Protocol for a prospective, randomized, controlled trial with a blinded evaluator. Eligible participants will be children with cerebral palsy (Levels I, II and III of the Gross Motor Function Classification System) between five and 12 years of age, with independent gait with or without a gait-assistance device. All participants will receive BT-A in the lower limbs (triceps surae). The children will then be randomly allocated for either treatment with motor physical therapy combined with NMES on the tibialis anterior or motor physical therapy alone. The participants will be evaluated on three occasions: 1) one week prior to the administration of BT-A; 2) one week after the administration of BT-A; and 3) four months after the administration of BT-A (end of intervention). Spasticity will be assessed by the Modified Ashworth Scale and Modified Tardieu Scale. Static balance will be assessed using the Medicapteurs Fusyo pressure platform and functional balance will be assessed using the Berg Balance Scale.
The aim of this protocol study is to describe the methodology of a randomized, controlled, clinical trial comparing the effect of motor physical therapy combined with NMES on the tibialis anterior muscle or motor physical therapy alone on static and functional balance in children with CP submitted to BT-A in the lower limbs. This study describes the background, hypotheses, methodology of the procedures and measurement of the results.
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在脑瘫（CP）患儿中，使用肉毒毒素 A（BT-A）治疗下肢痉挛是很常见的。BT-A 治疗后，物理治疗在增强患儿的功能方面起着重要作用。CP 患儿的平衡缺陷主要是由肌肉失衡（痉挛性激动肌和弱拮抗肌）引起的。神经肌肉电刺激（NMES）是一种很有前途的治疗方法，可以增强该人群的肌肉力量。本研究旨在描述一项研究方案，该方案旨在分析 NMES 对 BT-A 治疗后 CP 患儿背屈肌的影响，并结合物理治疗对其静态和功能性平衡的影响。
方法/设计：这是一项前瞻性、随机、对照试验，评估者设盲。符合条件的参与者将是年龄在 5 至 12 岁之间、具有独立行走能力（或不依赖行走辅助设备）的 CP 患儿（粗大运动功能分级系统 I、II 和 III 级）。所有参与者的下肢都将接受 BT-A 注射。然后，将患儿随机分配到接受运动物理疗法联合胫骨前肌 NMES 治疗或单独运动物理疗法治疗。参与者将在三个时间点进行评估：1）BT-A 注射前一周；2）BT-A 注射后一周；3）BT-A 注射后四个月（干预结束时）。痉挛将采用改良 Ashworth 量表和改良 Tardieu 量表进行评估。静态平衡将采用 Medicapteurs Fusyo 压力平台进行评估，功能性平衡将采用 Berg 平衡量表进行评估。
本方案研究的目的是描述一项随机、对照、临床试验的方法，比较 BT-A 注射后下肢运动物理疗法联合胫骨前肌 NMES 与单独运动物理疗法对 CP 患儿静态和功能性平衡的影响。本研究描述了背景、假设、程序方法和结果测量。
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