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Behavioural Intervention for Dysphagia in Acute Stroke

This study has been completed.
Sponsor:
Collaborator:
Royal Perth Hospital Medical Research Foundation
Information provided by:
Royal Perth Hospital
ClinicalTrials.gov Identifier:
NCT00257764
First received: November 21, 2005
Last updated: May 4, 2006
Last verified: June 1999
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Dysphagia Therapies for Swallowing Disorders Following Stroke.

Resource links provided by NLM:

U.S. FDA Resources

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 .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257764

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

Publications:

ClinicalTrials.gov Identifier: NCT00257764     History of Changes
Other Study ID Numbers: RPH00096
Study First Received: November 21, 2005
Last Updated: May 4, 2006
Health Authority: Australia: National Health and Medical Research Council

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

Additional relevant MeSH terms:
Deglutition Disorders
Stroke
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013