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Open Access Highly Accessed Study protocol

Static balance and function in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation: Study protocol for prospective, randomized, controlled trial

Soráia Kazon1, Luanda A C Grecco1, Hugo Pasini1, João C F Corrêa1, Thaluanna C L Christovão1, Paulo de TarsoCamillo de Carvalho14, Lilian Chrystiane Giannasi12, Paulo R G Lucareli1, Luis Vicente Franco de Oliveira1, Afonso Shiguemi Inoue Salgado3, Luciana M M Sampaio1 and Claudia S Oliveira1*

Author Affiliations

1 Post Graduate Program in Reabilitation Sciences, Nove de Julho University, UNINOVE, Sao Paulo, Brazil

2 Postdoctoral Fellowship of the Oral Biopathology Postgraduation Program- Unesp/Faculty of Dentistry, Sao Paulo, Brazil

3 Physical Therapist, Student in Doctor’s Program in Biomedical Engeneering, Camilo Castelo Branco University, Sao Paulo, Brazil

4 Post Graduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University, UNINOVE, Sao Paulo, Brazil

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BMC Pediatrics 2012, 12:53  doi:10.1186/1471-2431-12-53

Published: 16 May 2012

Abstract

Background

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.

Discussion

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.

Trial registration

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