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NCT00257764 Clinical Trial

Behavioural Intervention for Dysphagia in Acute Stroke

Dysphagia Clinical Trial

Official title:
A Randomised Controlled Trial of Dysphagia Therapies for Swallowing Disorders Following Stroke.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00257764
Other study ID # RPH00096
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received November 21, 2005
Last updated May 4, 2006
Start date May 1996
Est. completion date May 1999

Study information
Verified date June 1999
Source Royal Perth Hospital
Contact n/a
Is FDA regulated No
Health authority Australia: National Health and Medical Research Council
Study type Interventional

Clinical Trial 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”.

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 .

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date May 1999
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• behavioral swallowing exercises/ strategies

Locations
Country Name City State
Australia Royal Perth Hospital Perth Western Australia

Sponsors (2)
Lead Sponsor Collaborator
Royal Perth Hospital Royal Perth Hospital Medical Research Foundation

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary survival free of an abnormal diet at 6 months
Secondary time to return to normal diet over the study
Secondary recovery of swallowing ability at 6 months after stroke
Secondary the occurrence of dysphagia – related medical complications at 6 months.
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