Single session osteopathic manipulative treatment in Parkinson's disease: a randomized clinical trial protocol

The aim of the study is to evaluate the influence of a single session of OMT in individuals with PD based on ICF domains. Randomized clinical trial protocol available at the link: https://ensaiosclinicos.gov.br/rg/RBR-7pkypg3, in which 60 individuals diagnosed with PD are randomly allocated to one of two groups (Control, n=30 and OMT, n=30). Participants will be evaluated in 2 moments (baseline and post-treatment). The control group will not undergo any intervention and remains lying for 30 minutes. Protocol will be applied to the OMT group. The following outcomes will be compared: TUG (G-Walk (R)), gait speed (G-Walk (R)), C7 measurement test for the wall of the flexed trunk posture, evaluation of the range of motion of ankle dorsiflexion and MiniBESTest. A descriptive analysis of sociodemographic variables will be carried out. The statistical analysis will consider data distribution for the statistical test selection.The dependent T-test will be used to compare baseline and post-measurements for variables with normal distribution. For variables with non-normal distribution, the Wilcoxon signed rank test will be adopted. The effect size will be evaluated through the Pearson coefficient in which O (no effect) and (perfect effect). A confidence interval of 95% will be adopted and statistical significance p<0.05 will be considered. We hypothesized that the use of OMT could bring positive effects in relation to the improvement of gait, posture, balance, dorsiflexion ROM and general mobility. OMT may be a therapeutic approach to consider for individuals with PD.