2. Methods
2.1. Study design
This was a prospective double-blind parallel arm simple randomized controlled trial comparing the effects of BoNT-A,
combined with an individualized intensive physiotherapy/orthoses treatment, with placebo, conducted in two Italian
centres. It was built following CONSORT guidelines (Weller & McNeil, 2010). The approval of the competent Committee on
research ethics of the involved clinical centres was obtained