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Behavioural Intervention for Dysphagia in Acute Stroke

This study has been completed.
Royal Perth Hospital Medical Research Foundation
Information provided by:
Royal Perth Hospital Identifier:
First received: November 21, 2005
Last updated: May 4, 2006
Last verified: June 1999
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”.

Condition Intervention Phase
Dysphagia Behavioral: behavioral swallowing exercises/ strategies Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Dysphagia Therapies for Swallowing Disorders Following Stroke.

Resource links provided by NLM:

Further study details as provided by Royal Perth Hospital:

Primary Outcome Measures:
  • survival free of an abnormal diet at 6 months

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 300
Study Start Date: May 1996
Estimated Study Completion Date: May 1999
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 .


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00257764

Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
Royal Perth Hospital
Royal Perth Hospital Medical Research Foundation
Study Director: Graeme Hankey, MBBS, MD, Royal Perth Hospital
Principal Investigator: Giselle D Mann, MPH,PhD Royal Perth Hospital
  More Information

Publications: Identifier: NCT00257764     History of Changes
Other Study ID Numbers: RPH00096
Study First Received: November 21, 2005
Last Updated: May 4, 2006

Keywords provided by Royal Perth Hospital:
Swallowing disorder
Standardized swallowing therapy
Randomized controlled trial

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases processed this record on September 21, 2017