Behavioural intervention for dysphagia in acute stroke: a randomised controlled trial

Summary Background Swallowing dysfunction after stroke is common, but there is little reliable evidence for how the disorder should be managed. This study compared standard low-intensity and high-intensity behavioural interventions with usual care for dysphagia. Methods 306 patients with clinical dysphagia admitted to hospital with acute stroke were randomly assigned to receive usual care (n=102), prescribed by the attending physician; standard low-intensity intervention (n=102), comprising swallowing compensation strategies and diet prescription three times weekly for up to a month; or standard high-intensity intervention and dietary prescription (n=102), at least daily for up to a month. The primary outcome measure was survival free of an abnormal diet at 6 months. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00257764. Findings 60 patients died and three patients were lost to follow up before the 6-month analysis. Of patients randomly allocated usual care, 56% (57/102) survived at 6 months free of an abnormal diet compared with 67% (136/204) allocated standard swallowing therapy (relative risk 1•19, 95% CI 0•98–1•45). Standard swallowing therapy was associated with a non-significant trend toward a reduction in death (0•80, 0•5–1•3), institutionalisation (0•69, 0•4–1•1), and dependency (1•05, 0•8–1•3); a significant reduction in swallowing-related medical complications (0•73, 0•6–0•9), chest infection (0•56, 0•4–0•8), and death or institutionalisation (0•73, 0•55–0•97); and a significant rise in the proportion of patients regaining swallowing function (1•41, 1•03–1•94) by 6 months. Compared with usual care and low-intensity therapy, high-intensity therapy was associated with an increased proportion of patients who returned to a normal diet (p=0•04) and recovered swallowing (p=0•02) by 6 months. Interpretation These data show a consistent trend towards more favourable outcomes in dysphagic stroke patients who are assigned a standard programme of early behavioural swallowing intervention, including active therapeutic approaches and dietary modification.