Behavioural Intervention for Dysphagia in Acute Stroke

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00257764

Enrollment

300

Registered

2005-11-23

Start date

1996-05-31

Completion date

1999-05-31

Last updated

2006-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

Keywords

Swallowing disorder, Stroke, Standardized swallowing therapy, Randomized controlled trial

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 .

Interventions

BEHAVIORALbehavioral swallowing exercises/ strategies

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
survival free of an abnormal diet at 6 months	—

Secondary

Measure	Time frame
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.	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026