Behavioural Intervention for Dysphagia in Acute Stroke - Full Text View

Sponsors and Collaborators:	Royal Perth Hospital Royal Perth Hospital Medical Research Foundation
Information provided by:	Royal Perth Hospital
ClinicalTrials.gov Identifier:	NCT00257764

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 II Phase III

MedlinePlus related topics: Swallowing Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	A Randomised Controlled Trial of Dysphagia Therapies for Swallowing Disorders Following Stroke.

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 of Results:

Carnaby G, Hankey GJ, Pizzi J. Behavioural intervention for dysphagia in acute stroke: a randomised controlled trial. Lancet Neurol. 2006 Jan;5(1):31-7.

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

Keywords provided by Royal Perth Hospital:

Swallowing disorder
Stroke
Standardized swallowing therapy
Randomized controlled trial

Study placed in the following topic categories:

Deglutition Disorders
Otorhinolaryngologic Diseases
Digestive System Diseases
Esophageal disorder
Cerebral Infarction

Gastrointestinal Diseases
Stroke
Esophageal Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on January 13, 2009