Generalizability of Results from Randomized Controlled Trials in Post-Stroke Physiotherapy

Abstract

Purpose: The randomized controlled trial (RCT) is considered a reliable experimental design, able to detect the effect of an intervention. However, a criticism frequently levelled at RCTs by clinicians is their lack of generalizability. This study aimed to evaluate the generalizability of findings from RCTs of physiotherapy interventions for individuals with stroke. Method: A sample of RCTs of physiotherapy interventions after stroke indexed in the PEDro database was selected, and the reported inclusion and exclusion criteria were analyzed. Results: We reviewed 100 articles, which included 7,366 participants (41.6% women, with a mean weighted age of 65.5 years). The most frequent criteria for exclusion were comorbidity (83%), cognitive impairments (69%), communication skills (55%), recurrent stroke (53%), low functional level (47%) and being elderly (25%). Conclusions: A variety of cohorts of individuals who have had a stroke are excluded from RCTs published in the field of physiotherapy. Because they represent a substantial proportion of the real-world population with stroke, and consequently treated in clinical practice, more vulnerable cohorts of participants should be included in RCTs.