Replication Data for: Myelomeningocele

This is a protocol randomized clinical blind study, that will include 30 individuals of both sexes, aged between 5 to 8 years, diagnosed with low and sacral lumbar myelomeningocele and capable of performing the sit-to-stand task. The participants will be randomly assigned into two treatment groups: PBM + physiotherapeutic exercises and sham PBM + physiotherapeutic exercises. Irradiation will be carried out with light emitting diode (LED) at a wavelength of 850 nm, energy of 25 J per point, 50 seconds per point and a power of 200 mW. The same device will be used in the placebo group but will not emit light. Muscle activity will be assessed using a portable electromyograph (BTS Engineering) and the sit-to-stand task will be performed as a measure of functioning. Electrodes will be positioned on the lateral gastrocnemius, tibialis anterior and rectus femoris muscles. The Pediatric Evaluation of Disability Inventory will be used to assess functional independence. Quality of life will be assessed using the Child Health Questionnaire - Parent Form 50. Changes in participation will be assessed using the Participation and Environment Measure for Children and Youth. Descriptive statistics will be performed to determine the normality of the data and the mean change (standard deviation, 95% confidence interval) in each group will be calculated. GraphPad PRISM version 7.0 (GraphPad Software - São Diego, CA, USA) will be used for all analyses. A mixed factor ANOVA model will be employed to compare the effects of the interventions in each group in terms of functional variables (PEDI and EMG), quality of life questionnaire and social participation over time (pre-treatment, post-treatment and 30-day follow-up). A 95% confidence interval will be used to establish any differences and a p-value <0.05 will be indicative of a statistically significant difference between groups (two-tailed). If the supposition of normality is not met, pairwise comparisons between groups will be performed using a nonparametric test, as appropriate, for independent samples (Mann-Whitney U test) or dependent samples (Wilcoxon test). The alpha level will be adjusted to 0.0033 (Bonferroni correction) to avoid a type 1 error.