Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00257764




Registration number
NCT00257764
Ethics application status
Date submitted
21/11/2005
Date registered
23/11/2005
Date last updated
5/05/2006

Titles & IDs
Public title
Behavioural Intervention for Dysphagia in Acute Stroke
Scientific title
A Randomised Controlled Trial of Dysphagia Therapies for Swallowing Disorders Following Stroke.
Secondary ID [1] 0 0
RPH00096
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
survival free of an abnormal diet at 6 months
Timepoint [1] 0 0
Secondary outcome [1] 0 0
time to return to normal diet over the study
Timepoint [1] 0 0
Secondary outcome [2] 0 0
recovery of swallowing ability at 6 months after stroke
Timepoint [2] 0 0
Secondary outcome [3] 0 0
the occurrence of dysphagia - related medical complications at 6 months.
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
* clinical diagnosis of stroke within the previous 7 days
* clinical diagnosis of swallowing difficulty
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* no previous history of swallowing treatment
* no previous history of surgery of the head or neck

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/1996
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Perth Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Perth Hospital Medical Research Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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".
Trial website
https://clinicaltrials.gov/study/NCT00257764
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Graeme Hankey, MBBS, MD,
Address 0 0
Royal Perth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00257764