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Open Access Highly Accessed Study protocol

Effect of posture-control insoles on function in children with cerebral palsy: Randomized controlled clinical trial

Hugo Pasini Neto1, Luanda André Collange Grecco1, Thaluanna CL Christovão1, Luiz Alfredo Braun1, Lilian Chrystiane Giannasi12, Afonso Shiguemi Inoue Salgado3, Renata Calhes Franco de Moura1, Paulo de Tarso Camillo de Carvalho1, João CF Corrêa1, Luciana MM Sampaio1, Manuela Galli45 and Claudia Santos Oliveira16*

Author Affiliations

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

2 Postdoctoral Fellowship of the Oral Bio pathology Post graduation Program- Unesp/Faculty of Dentistry, Sao Paulo, Brazil

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

4 Associate Professor and director of “Luigi Divieti ”Motion analysis Lab, Dipartimento di Bioingegneria, Politecnico di Milano, Milan, Italy

5 Motion analysis Lab, IRCCS San Raffaele Pisana, Tosinvest Sanità, Rome, Italy

6 Integrated Laboratory of Human Movement Analysis, Universidade Nove de Julho - UNINOVE, São Paulo, SP, Brazil

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BMC Musculoskeletal Disorders 2012, 13:193  doi:10.1186/1471-2474-13-193

Published: 4 October 2012

Abstract

Introduction

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).

Trial Registration

Trial Registration Number: RBR6d342s (http://www.ensaiosclinicos.gov.br/news/ webcite)

Keywords:
Cerebral palsy; Posture-control insoles; Ankle-foot orthosis; Electromyography; Gait; Stabilometry; Rehabilitation