DysphagiaPhase 2/3NCT00257764
Behavioural Intervention for Dysphagia in Acute Stroke
A Phase 2/3 study testing behavioral swallowing exercises/ strategies in people with Dysphagia, run by Royal Perth Hospital at 1 site in Australia.
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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- behavioral swallowing exercises/ strategies
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 1 siteAustralia
- Study dates
- May 1996to May 1999
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of stroke within the previous 7 days
- clinical diagnosis of swallowing difficulty
Who cannot join
- no previous history of swallowing treatment
- no previous history of surgery of the head or neck
Trial locations and contacts
1 site in 1 country.
About this study
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".
Read the 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 .
- Conditions
- Dysphagia
- Being tested
- behavioral swallowing exercises/ strategies
- Keywords
- Swallowing disorder, Stroke, Standardized swallowing therapy, Randomized controlled trial
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral swallowing exercises/ strategiesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
survival free of an abnormal diet at 6 months
Secondary outcomes (3)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2005 (estimated)
- Study startMay 1996
- Study completionMay 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Royal Perth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Perth Hospital Medical Research Foundation
- Investigators
- Graeme Hankey, MBBS, MD,, Study director, Royal Perth HospitalGiselle D Mann, MPH,PhD, Principal investigator, Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257764
- Sponsor's protocol ID
- RPH00096
- Status last verified
- Jun 1999
- First submitted
- 21 Nov 2005
- Last updated
- 5 May 2006
- Results posted
- No
Publications
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.
PubMed 16361020
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Dysphagia Therapies for Swallowing Disorders Following Stroke.
- ClinicalTrials.gov ID
- NCT00257764
- Acronym / sponsor ID
- RPH00096
- Conditions
- Dysphagia
- Keywords
- Swallowing disorder, Stroke, Standardized swallowing therapy, Randomized controlled trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Royal Perth HospitalUniversity, hospital or other
- Collaborators
- Royal Perth Hospital Medical Research Foundation
- Study start
- May 1996
- Study completion
- May 1999
- First posted
- 23 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of stroke within the previous 7 days
- clinical diagnosis of swallowing difficulty
Key exclusion criteria (2 listed)
- no previous history of swallowing treatment
- no previous history of surgery of the head or neck
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral swallowing exercises/ strategies | Behavioural | – |
Primary outcome
survival free of an abnormal diet at 6 months
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2006.
- Results publication: PubMed 16361020Carnaby 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.
Related trials for Dysphagia
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Active, not recruitingObservational study
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
Postoperative Sore Throat, Bronchoscopy
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Brief Resolved Unexplained Event, Apparent Life Threatening Event
Enrolling by invitation
Non-invasive Markers of Esophageal Function in Adults
Dysphagia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graeme Hankey, MBBS, MD, study director
Royal Perth Hospital
Giselle D Mann, MPH,PhD principal investigator
Royal Perth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing behavioral swallowing exercises/ strategies in people with Dysphagia, run by Royal Perth Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival free of an abnormal diet at 6 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00257764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2006; AzTrials last refreshed its copy on 31 Oct 2026.