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Behavioural Intervention for Dysphagia in Acute Stroke

NCT ID: NCT00257764

Last Updated: 2006-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-05-31

Study Completion Date

1999-05-31

Brief Summary

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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

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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 .

Conditions

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Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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behavioral swallowing exercises/ strategies

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Perth Hospital Medical Research Foundation

UNKNOWN

Sponsor Role collaborator

Royal Perth Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Graeme Hankey, MBBS, MD,

Role: STUDY_DIRECTOR

Royal Perth Hospital

Giselle D Mann, MPH,PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Perth Hospital

Locations

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Royal Perth Hospital

Perth, Western Australia, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type RESULT
PMID: 16361020 (View on PubMed)

Other Identifiers

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RPH00096

Identifier Type: -

Identifier Source: org_study_id