StrokeNCT00288834
Outcomes of Swallowing Rehabilitation After Stroke
A study testing dysphagia rehabilitation in people with Stroke and Cerebrovascular Accident, run by University of Canterbury at 9 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Accident, Dysphagia
- What is being tested?
- dysphagia rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 9 sitesin 4 countries
- Study dates
- Aug 2001to Jul 2006
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- history of pre-existing dysphagia or neurologic disease prior to the onset of the current disorder.
- MMSE score < 21
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Canada5 sites
Glenrose Rehabilitation Centre
Edmonton, Alberta
Hamilton Health Sciences Centre
Hamilton, Ontario
Trillium Health Centre
Mississauga, Ontario
Leonard Miller Rehabilitation Centre
St. John's, Newfoundland and Labrador
Deer Lodge Centre
Winnipeg, Manitoba
Australia2 sites
Fremantle Hospital
Fremantle, Western Australia
Austin and Repatriation Medical Centre
Melbourne, Victoria
About this study
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.
- Research Question to be addressed
- 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.
- 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).
Read the detailed description
This multi-site, multi-national project will evaluate the relative effectiveness of four therapy protocols for pharyngeal phase swallowing impairment in the stroke population. For this study, patients with chronic dysphagia secondary to stroke will be assigned to one of four treatment protocols. These four protocols differ in respect to the intensity of treatment and the inclusion of surface electromyography (SEMG) biofeedback as an adjunct to treatment. All patients will complete a total of 30 hours of therapy with data collection to assess progress at intervals of every 10 sessions. Treatment outcomes will be measured using a combination of physiologic and behavioral measures. 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.
- Conditions
- Stroke, Cerebrovascular Accident, Dysphagia
- Being tested
- dysphagia rehabilitation
- Keywords
- stroke, dysphagia, rehabilitation, biofeedback
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dysphagia rehabilitationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The following outcomes measures will be assessed after 10. 20 and 30 therapeutic sessions:
Severity rankings of swallowing pathophysiology based on videofluoroscopic swallowing studies Videofluoroscopic swallowing studies
Functional outcome ratings of associated clinical parameters (respiratory, neurological status, self help, cognitive)
Quality of life ratings (SwalQOL) In addition, quality of life ratings (SwalQOL) will be assessed at one follow-up assessment six months post discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2006 (estimated)
- Study startAug 2001
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Canterbury
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Tan Tock Seng Hospital, Fremantle Hospital and Health Service, Austin Hospital, Melbourne Australia
- Investigators
- Maggie-Lee Huckabee, Ph.D., Principal investigator, University of Canterbury, Van der Veer Institute for Parkinson's and Brain Research, Christchurch New ZealandCatriona M. Steele, Ph.D., Principal investigator, Toronto Rehabilitation Institute, Toronto CanadaPascal van Lieshout, Ph.D., Principal investigator, University of Toronto, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288834
- Sponsor's protocol ID
- HSF NA 4992
- Other IDs
- NZ CMRF 01/10
- Status last verified
- Feb 2006
- First submitted
- 6 Feb 2006
- Last updated
- 8 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Swallowing Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT00288834
- Acronym / sponsor ID
- HSF NA 4992
- Conditions
- Stroke, Cerebrovascular Accident, Dysphagia
- Keywords
- stroke, dysphagia, rehabilitation, biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of CanterburyUniversity, hospital or other
- Collaborators
- University of Toronto, Tan Tock Seng Hospital, Fremantle Hospital and Health Service, Austin Hospital, Melbourne Australia
- Study start
- Aug 2001
- Study completion
- Jul 2006
- First posted
- 8 Feb 2006 (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.
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.
- Research Question to be addressed
- 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.
- 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).
Detailed description
This multi-site, multi-national project will evaluate the relative effectiveness of four therapy protocols for pharyngeal phase swallowing impairment in the stroke population. For this study, patients with chronic dysphagia secondary to stroke will be assigned to one of four treatment protocols. These four protocols differ in respect to the intensity of treatment and the inclusion of surface electromyography (SEMG) biofeedback as an adjunct to treatment. All patients will complete a total of 30 hours of therapy with data collection to assess progress at intervals of every 10 sessions. Treatment outcomes will be measured using a combination of physiologic and behavioral measures. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- history of pre-existing dysphagia or neurologic disease prior to the onset of the current disorder.
- MMSE score < 21
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 |
|---|---|---|
| dysphagia rehabilitation | Behavioural | – |
Primary outcome
The following outcomes measures will be assessed after 10. 20 and 30 therapeutic sessions:
Severity rankings of swallowing pathophysiology based on videofluoroscopic swallowing studies Videofluoroscopic swallowing studies
Functional outcome ratings of associated clinical parameters (respiratory, neurological status, self help, cognitive)
Quality of life ratings (SwalQOL) In addition, quality of life ratings (SwalQOL) will be assessed at one follow-up assessment six months post discharge.
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 8 Feb 2006.
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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.
Maggie-Lee Huckabee, Ph.D. principal investigator
University of Canterbury, Van der Veer Institute for Parkinson's and Brain Research, Christchurch New Zealand
Catriona M. Steele, Ph.D. principal investigator
Toronto Rehabilitation Institute, Toronto Canada
Pascal van Lieshout, Ph.D. principal investigator
University of Toronto, Toronto Canada
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dysphagia rehabilitation in people with Stroke and Cerebrovascular Accident, run by University of Canterbury at 9 sites in 4 countries.
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 5 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 8 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, Australia, New Zealand, Singapore. 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.
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?
The following outcomes measures will be assessed after 10. 20 and 30 therapeutic sessions:. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2006.