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Behavioural Intervention for Dysphagia in Acute Stroke

Phase 2
Completed
Conditions
Dysphagia
Registration Number
NCT00257764
Lead Sponsor
Royal Perth Hospital
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 Description

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 .

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
300
Inclusion Criteria
  • clinical diagnosis of stroke within the previous 7 days
  • clinical diagnosis of swallowing difficulty
Exclusion Criteria
  • no previous history of swallowing treatment
  • no previous history of surgery of the head or neck

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
survival free of an abnormal diet at 6 months
Secondary Outcome Measures
NameTimeMethod
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.

Trial Locations

Locations (1)

Royal Perth Hospital

🇦🇺

Perth, Western Australia, Australia

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