Post Graduate Program in Reabilitation Sciences, Universidade Nove de Julho, UNINOVE, Sao Paulo, Brazil.
BMC Musculoskelet Disord. 2012 Oct 4;13:193. doi: 10.1186/1471-2474-13-193.
Cerebral palsy (CP) is a posture and movement disorder and different therapeutic modalities, such as the use of braces, have sought to favor selective motor control and muscle coordination in such patients. The aim of the proposed study is to determine the effect of the combination of posture-control insoles and ankle-foot orthoses (AFOs) improving functional limitation in children with CP.
METHODS/DESIGN: The sample will be composed of 24 children with CP between four and 12 years of age. After the signing of the statement of informed consent, the children will be randomly allocated to two groups: a control group using AFOs alone and an experimental group using both posture-control insoles and AFOs. Evaluations will be performed on five occasions: without any accessory (insoles or AFOs), immediately after, one month after, six months after and one year after AFOs or insole and AFOs use. The evaluation will involve the analysis of gait, static and functional balance, mobility and hypertonia. The three-dimensional assessment of gait will involve the eight-camera SMART-D SMART-D 140® system (BTS Engineering), two Kistler force plates (model 9286BA) and an eight-channel, wireless FREEEMG® electromyography (BTS Engineering). Static balance will be assessed using a Kistler force plate (model 9286BA). Clinical functional balance and mobility will be assessed using the Berg Balance Scale, Timed Up-and-Go Test and Six-Minute Walk Test. The posture-control insoles will be made of ethylene vinyl acetate, with thermal molding for fixation. The fixed orthoses will be made of polypropylene and attached to the ankle region (AFO). The results will be analyzed statistically, with the level significance set to 5% (p < 0.05).
RBR6d342s (http://www.ensaiosclinicos.gov.br/news/).
脑瘫（CP）是一种姿势和运动障碍，不同的治疗方法，如使用支具，旨在促进此类患者的选择性运动控制和肌肉协调。本研究旨在确定使用姿势控制鞋垫和踝足矫形器（AFO）相结合是否能改善脑瘫儿童的功能受限。
方法/设计：该样本将由 24 名 4 至 12 岁的脑瘫儿童组成。在签署知情同意书后，将患儿随机分为两组：单独使用 AFO 的对照组和同时使用姿势控制鞋垫和 AFO 的实验组。将进行五次评估：不使用任何辅助器具（鞋垫或 AFO）、使用后立即、一个月后、六个月后和一年后使用 AFO 或鞋垫和 AFO。评估将包括步态、静态和功能性平衡、移动性和张力的分析。步态的三维评估将涉及八相机 SMART-D SMART-D 140®系统（BTS Engineering）、两个 Kistler 力板（型号 9286BA）和一个八通道、无线 FREEEMG®肌电图（BTS Engineering）。静态平衡将使用 Kistler 力板（型号 9286BA）进行评估。临床功能性平衡和移动性将使用 Berg 平衡量表、计时起立行走测试和六分钟步行测试进行评估。姿势控制鞋垫由乙烯醋酸乙烯酯制成，采用热成型固定。固定矫形器由聚丙烯制成，附在踝关节区域（AFO）。结果将进行统计学分析，显著性水平设定为 5%（p < 0.05）。
