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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00288834




Registration number
NCT00288834
Ethics application status
Date submitted
6/02/2006
Date registered
8/02/2006
Date last updated
8/02/2006

Titles & IDs
Public title
Outcomes of Swallowing Rehabilitation After Stroke
Scientific title
Outcomes of Swallowing Rehabilitation After Stroke
Secondary ID [1] 0 0
NZ CMRF 01/10
Secondary ID [2] 0 0
HSF NA 4992
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Cerebrovascular Accident 0 0
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
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - dysphagia rehabilitation

Behaviour: dysphagia rehabilitation
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The following outcomes measures will be assessed after 10. 20 and 30 therapeutic sessions:
Timepoint [1] 0 0
Primary outcome [2] 0 0
Severity rankings of swallowing pathophysiology based on videofluoroscopic swallowing studies Videofluoroscopic swallowing studies
Timepoint [2] 0 0
Primary outcome [3] 0 0
Functional outcome ratings of associated clinical parameters (respiratory, neurological status, self help, cognitive)
Timepoint [3] 0 0
Primary outcome [4] 0 0
Quality of life ratings (SwalQOL) In addition, quality of life ratings (SwalQOL) will be assessed at one follow-up assessment six months post discharge.
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
- Subjects will represent the diagnostic categories of single event brain stem injury,
right cortical stroke and left cortical stroke.

- Chronic dysphagia at least 6 months post onset secondary to single neurological event,
brain stem, right cortical or left cortical stroke confirmed with CT or MRI

- Diagnosis of chronic pharyngeal phase dysphagia based on clinical and
videofluoroscopic evaluation completed within 3 weeks of beginning treatment.

- Must be at least 12 months post onset with no substantial recovery of swallowing
function. If patients have received prior swallowing treatment, they must be at least
three months post the termination of direct treatment.

- Mini Mental Status Exam score >21
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- history of pre-existing dysphagia or neurologic disease prior to the onset of the
current disorder.

- MMSE score < 21

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
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
1/08/2001
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)
VIC,WA
Recruitment hospital [1] 0 0
Austin and Repatriation Medical Centre - Melbourne
Recruitment hospital [2] 0 0
Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Fremantle
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Manitoba
Country [3] 0 0
Canada
State/province [3] 0 0
Newfoundland and Labrador
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
New Zealand
State/province [5] 0 0
Christchurch
Country [6] 0 0
Singapore
State/province [6] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
University of Canterbury
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Toronto
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Tan Tock Seng Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Fremantle Hospital and Health Service
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Austin Hospital, Melbourne Australia
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This project proposes to evaluate the relative effectiveness of four therapy protocols for
pharyngeal phase swallowing impairment in the stroke population. Data derived from this study
should contribute significantly to our understanding of the rehabilitative process in the
neurogenic dysphagic population and will provide the foundation for the establishment of
efficacious, cost-efficient patient services.

1. Research Question to be addressed

1. The utilization of SEMG biofeedback monitoring in dysphagia rehabilitation facilitates
more rapid and complete recovery than traditional rehabilitation using the same
swallowing exercises without exteroceptive feedback.

2. Swallowing rehabilitation provided in an intensive rehabilitative programme (10 hrs of
treatment in the 1st week) facilitates more rapid and complete recovery than
traditionally scheduled swallowing rehabilitation (twice weekly).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00288834
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maggie-Lee Huckabee, Ph.D.
Address 0 0
University of Canterbury, Van der Veer Institute for Parkinson's and Brain Research, Christchurch New Zealand
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/ct2/show/NCT00288834