Designing a Clinical Trial to Determine the Effect of Conventional Physiotherapy Plus Ankle KinesioTaping® on Walking and Balance in Children with Spastic Diplegia Cerebral Palsy: A Protocol for a Double-Blind Randomized Clinical Trial

Abstract

Introduction: This study is a protocol of a double-blind randomized clinical trial with the aim of determining the effect of ankle KinesioTape® in addition to the routine physiotherapy approach on walking and balance of children with cerebral palsy (CP) suffering from spastic diplegia. Materials and Methods: The present clinical trial was performed on 20 children who were randomly divided into the two groups of control and intervention. 4 weeks of routine physiotherapy program was carried out for all the participants in both groups. In the intervention group, the KinesioTape® was applied to the ankles of the patients for 4 weeks in addition to the routine treatment. After completing this course, a 6-week follow-up phase was conducted for both groups, in which both groups received routine physiotherapy treatment. The treatment program was repeated twice a week. The outcome measures included modified Timed Up and Go (TUG) test, Gross Motor Function Measure (GMFM), and Pediatric Balance Scale (PBS). The normal distribution of the data was determined using the Shapiro-Wilks test. Paired-sample t-test and Wilcoxon nonparametric test were employed to analyze the data and check for changes before and after the treatment in each group. Additionally, the repeated measures analysis of variance (ANOVA) was used to compare between the two groups (P < 0.05). Conclusion: KinesioTape® improves voluntary movement, coordination and balance, and functional independence in children with CP. According to the comprehensive search of literature, it seems that no study to date has examined the effect of ankle equinus corrective KinesioTaping® on walking and balance in children with spastic diplegia. The results of the study can be used to examine the effectiveness of the addition of ankle Kinesio Taping® to physiotherapy on the function and balance of these children.