Study protocol of a randomised controlled trial for the effectiveness of a functional partial body weight support treadmill training (FPBWSTT) on motor and functional skills of children with ataxia

INTRODUCTION: A great heterogeneity characterises the paediatric population with ataxia, which has been studied poorly. The lack of postural control and coordination, in addition with features of the ‘ataxic’ gait are linked with functional limitations. Studies on physiotherapy interventions for children with ataxia are highly needed for identifying optimal training strategies for improving motor and functional related skills. METHODS AND ANALYSIS: A stratified randomised control clinical trial of a 4-week functional partial body weight support treadmill training, (5 days/week 45 min/day) and 2-month follow-up period will be applied in children with ataxia, aged 8–18 years old with Gross Motor Function Classification System II–IV. Participants will be allocated to experimental group (intervention and usual care) or control group (usual care), using stratified randomisation process into two strata (progressive and non-progressive ataxia). Participants will be assessed at baseline, by the end of the 4-week period and by the end of a 2-month period as a follow-up measurement. Motor and functional skills will be assessed using the Gross Motor Function Measure-D and E, the Pediatric Balance Scale, the 10-meter walk test, the 6-minute walk test, the Scale for Assessment and Rating Ataxia, the timed up and go test and children’s spatiotemporal gait features will be assessed through GaitSens software recording over a 2 min low treadmill gait speed, while three-dimensional gait analysis will be performed for kinetic and kinematic analysis of the lower limbs in all three levels of movement. Two-way mixed Analysis of Variance (ANOVA) with factors ‘intervention’ (between group) and ‘time’ (within group) will be used for the analysis of all parameters. Analysis of Covariance (ANCOVA) will be used in case of imbalance of baseline measurements. Statistical significance will be set at p<0.05 using the statistical package SPSS V.21.00. ETHICS AND DISSEMINATION: University of West Attica (study’s protocol: 14η/26-04-2021) and ‘ATTIKON’ General University Hospital of Athens (study’s protocol: Γ ΠΑΙΔ, ΕΒΔ 149/20-3-2020). Trial results of the main trial will be submitted for publication in a peer-reviewed journal and/or international conference. TRAIL REGISTRATION NUMBER: ISRCTN54463720.