Trial Review

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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Carnaby G, Hankey GJ, Pizzi J. Behavioural interve... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00257764