Dysphagia Clinical Trial
Official title:
A Randomised Controlled Trial of Dysphagia Therapies for Swallowing Disorders Following Stroke.
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”.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Royal Perth Hospital | Perth | Western Australia |
Lead Sponsor | Collaborator |
---|---|
Royal Perth Hospital | Royal Perth Hospital Medical Research Foundation |
Australia,
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
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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