RCT design for the assessment of rehabilitation treatments: The case study of post-stroke rehabilitation

The need of evidence-based medicine is a key factor in the current clinical rehabilitative approach. A randomized controlled trial (RCT) is a rigorous scientific methodology used to test the efficacy and efficiency of a service in healthcare‚ such as a new technology‚ methodology‚ treatment or drug therapy. RCTs are becoming a milestone to establish novel rehabilitation approaches. Indeed‚ the findings of a well-designed RCT influence the decision making process in healthcare‚ the international evidence-based clinical pathways guidelines‚ and ultimately‚ the formulation of national public health policies. The aim of this chapter is to describe the rigorous methodology that should be followed to design a RCT to demonstrate the efficacy of a novel rehabilitation intervention. The chapter is organized in four sections. The first section describes the main characteristics of an RCT (i.e. the randomization and the comparison with a control group) explaining its importance. The second section highlights the ethical issues that raises studying human subjects. The third describes the possible source of bias that should be considered designing an RCT and finally the fourth present the step by step procedure to follow in the design of an RCT reporting also a clinical example of an ongoing RCT.