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Behavioural Intervention for Dysphagia in Acute Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00257764
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : May 5, 2006
Royal Perth Hospital Medical Research Foundation
Information provided by:
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”.

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

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 .

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
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.
Study Start Date : May 1996
Study Completion Date : May 1999

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. time to return to normal diet over the study
  2. recovery of swallowing ability at 6 months after stroke
  3. the occurrence of dysphagia - related medical complications at 6 months.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00257764

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Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
Royal Perth Hospital
Royal Perth Hospital Medical Research Foundation
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Study Director: Graeme Hankey, MBBS, MD, Royal Perth Hospital
Principal Investigator: Giselle D Mann, MPH,PhD Royal Perth Hospital
Publications of Results:
Layout table for additonal information Identifier: NCT00257764    
Other Study ID Numbers: RPH00096
First Posted: November 23, 2005    Key Record Dates
Last Update Posted: May 5, 2006
Last Verified: June 1999
Keywords provided by Royal Perth Hospital:
Swallowing disorder
Standardized swallowing therapy
Randomized controlled trial
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases