Effectiveness of Physiotherapy for Improving Participation, Gross Motor Function, Gait and Balance in Children and Adolescents with Cerebral Palsy: Study Protocol for a Randomized Controlled Trial

Abstract

Background: People with cerebral palsy (CP) present with limitations in gait and functionality, with a great impact on participation. Physiotherapy interventions based on goal-directed training (GDT), treadmill gait training (TGT), and action observation treatment (AOT) showed to be effective for improving functionality, gait and balance in children and adolescents with CP. On the other hand, since COVID-19 lockdown, telecare has an increased role in physiotherapy interventions. The aim of this randomized controlled trial (RTC) is to analyze the effectiveness of a multimodal intervention that combines face-to-face PT sessions of GDT and TGT and online PT sessions of a family-centered education program, which includes AOT activities and is effective to improve participation, gross motor function, gait and balance in children and adolescents with CP. Methods: A single-blinded RCT is proposed for 48 children and adolescents with CP (6–17 years old) who will be randomly allocated into two groups: the experimental group will receive six weeks of a multimodal PT intervention with 12 face-to-face sessions (GDT and TGT) and 6 online sessions of a family-centered telecare EP, which includes AOT activities. Participants in the control group will carry on with their regular PT treatment plus the EP as the experimental group. The outcome variables of participation (CAPE); gait speed and endurance (10 mm/6 mm); gross motor function (GMFM-88-SP); and dynamic and static balance (PBS) will be collected at baseline, after group interventions and 12 weeks from baseline and will be compared following standard principles for RCTs. Conclusions: The implementation of a multimodal PT intervention that combines face-to-face sessions of GDT and TGT and online sessions of a family-centered EP, which includes AOT activities, may be effective to improve participation, gross motor function, gait and balance in children and adolescents with CP. Trial registration: ClinicalTrials.gov with ID: NCT04778930.