Effects of transcranial direct current stimulation combined with cognitive orientation to daily occupational performance in children with cerebral palsy: a protocol for a randomised controlled trial

Abstract

Background/Aims Children with hemiplegic cerebral palsy have limitations in activities requiring reach and manipulation of objects with their affected upper extremity. Transcranial direct current stimulation and the cognitive orientation to occupational performance approach are relatively new interventions that may lead to promising results for these children. This article describes the method of a randomised clinical trial that will compare the effects of the combination of transcranial direct current stimulation and cognitive orientation to daily occupational performance with transcranial direct current stimulation and neurodevelopmental treatment. Methods A four-armed clinical trial with a sample size of 36 participants will be performed in Tehran. Participants will be randomly divided into four groups. Group A will receive neuro-developmental treatment with sham transcranial direct current stimulation, group B will receive neurodevelopmental treatment with transcranial direct current stimulation, group C will receive cognitive orientation to daily occupational performance with sham transcranial direct current stimulation, and group D will receive cognitive orientation to daily occupational performance with transcranial direct current stimulation. The examiner will be blind to the study and assessments will be done at baseline, after the end of the intervention and 1 month after the completion of the intervention (as follow up). Data analysis will be as repeated measure analysis of variance and intention to treat. Conclusions This article describes the protocol of a clinical trial that compares the effects of the combination of transcranial direct current stimulation and cognitive orientation to daily occupational performance with the combination of transcranial direct current stimulation and neurodevelopmental treatment on upper extremity goals and functions of children with hemiplegic cerebral palsy.