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Completed

NCT Number: NCT00257764

Behavioural Intervention for Dysphagia in Acute 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".

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Key information

Conditions

Dysphagia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral swallowing exercises/ strategies

Behavioral

Primary outcomes

  1. survival free of an abnormal diet at 6 months

Secondary outcomes

  1. time to return to normal diet over the study

  2. recovery of swallowing ability at 6 months after stroke

  3. the occurrence of dysphagia - related medical complications at 6 months.

Sponsors and collaborators

Lead sponsor

Royal Perth Hospital

Other

Collaborators

  • Royal Perth Hospital Medical Research Foundation

Registry information

Official study title

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

Important dates

Study start
1996
Study completion
1999
First posted
Nov 23, 2005
Registry last updated
May 5, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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