Clinical Trial: Behavioural Intervention for Dysphagia in Acute Stroke
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomised Controlled Trial of Dysphagia Therapies for Swallowing Disorders Following Stroke.
Brief Summary: Swallowing dysfunction after stroke is common, but there is no reliable evidence for how it should be managed other than perhaps by nasogastric tube. This study compared the effectiveness of standardised, low and high intensity behavioral intervention for dysphagia with that of “usual care”.
Detailed Summary:
Stroke compromises swallowing function, causing dysphagia, in one quarter to one half of all patients. Dysphagia is associated with an increased risk of aspiration pneumonia, dehydration and malnutrition. Despite the development and implementation of several strategies of managing dysphagia after stroke, Few have been evaluated by means of randomised controlled trials.
Comparisons: This study aims to compare stroke patients with dysphagia assigned to receive usual swallowing care, prescribed by the attending physician; standardised low intensity intervention comprising swallowing compensation strategies and diet prescription; or standardised high intensity intervention and dietary prescription .
Sponsor: Royal Perth Hospital
Current Primary Outcome: survival free of an abnormal diet at 6 months
Original Primary Outcome: Same as current
Current Secondary Outcome:
- time to return to normal diet over the study
- recovery of swallowing ability at 6 months after stroke
- the occurrence of dysphagia – related medical complications at 6 months.
Original Secondary Outcome: Same as current
Information By: Royal Perth Hospital
Dates:
Date Received: November 21, 2005
Date Started: May 1996
Date Completion: May 1999
Last Updated: May 4, 2006
Last Verified: June 1999
