Behavioural Intervention for Dysphagia in Acute Stroke
Primary Purpose
Dysphagia
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
behavioral swallowing exercises/ strategies
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring Swallowing disorder, Stroke, Standardized swallowing therapy, Randomized controlled trial
Eligibility 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
Sites / Locations
- Royal Perth Hospital
Outcomes
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.
Full Information
NCT ID
NCT00257764
First Posted
November 21, 2005
Last Updated
May 4, 2006
Sponsor
Royal Perth Hospital
Collaborators
Royal Perth Hospital Medical Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00257764
Brief Title
Behavioural Intervention for Dysphagia in Acute Stroke
Official Title
A Randomised Controlled Trial of Dysphagia Therapies for Swallowing Disorders Following Stroke.
Study Type
Interventional
2. Study Status
Record Verification Date
June 1999
Overall Recruitment Status
Completed
Study Start Date
May 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 1999 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Perth Hospital
Collaborators
Royal Perth Hospital Medical Research Foundation
4. Oversight
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Swallowing disorder, Stroke, Standardized swallowing therapy, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
behavioral swallowing exercises/ strategies
Primary Outcome Measure Information:
Title
survival free of an abnormal diet at 6 months
Secondary Outcome Measure Information:
Title
time to return to normal diet over the study
Title
recovery of swallowing ability at 6 months after stroke
Title
the occurrence of dysphagia - related medical complications at 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graeme Hankey, MBBS, MD,
Organizational Affiliation
Royal Perth Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giselle D Mann, MPH,PhD
Organizational Affiliation
Royal Perth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
16361020
Citation
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. doi: 10.1016/S1474-4422(05)70252-0.
Results Reference
result
Learn more about this trial
Behavioural Intervention for Dysphagia in Acute Stroke
We'll reach out to this number within 24 hrs