Clinical trial NCT00288834: Outcomes of Swallowing Rehabilitation After Stroke
Official title: Outcomes of Swallowing Rehabilitation After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cerebrovascular Accident
Dysphagia
Keywords: stroke
dysphagia
rehabilitation
biofeedback
Lead sponsor: University of Canterbury
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Tan Tock Seng Hospital
name: Fremantle Hospital and Health Service
name: Austin Hospital, Melbourne Australia
First posted: 2006-02-08
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Exclusion Criteria:

* history of pre-existing dysphagia or neurologic disease prior to the onset of the current disorder.
* MMSE score \< 21

Primary outcomes:
measure: The following outcomes measures will be assessed after 10. 20 and 30 therapeutic sessions:
measure: Severity rankings of swallowing pathophysiology based on videofluoroscopic swallowing studies Videofluoroscopic swallowing studies
measure: Functional outcome ratings of associated clinical parameters (respiratory, neurological status, self help, cognitive)
measure: Quality of life ratings (SwalQOL) In addition, quality of life ratings (SwalQOL) will be assessed at one follow-up assessment six months post discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Austin and Repatriation Medical Centre
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Hospital
state: Western Australia
city: Edmonton
country: Canada
facility: Glenrose Rehabilitation Centre
state: Alberta
city: Winnipeg
country: Canada
facility: Deer Lodge Centre
state: Manitoba
city: St. John's
country: Canada
facility: Leonard Miller Rehabilitation Centre
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Centre
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Centre
state: Ontario
city: Christchurch
country: New Zealand
facility: Princess Margaret Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: University of Canterbury, Van der Veer Institute for Parkinson's and Brain Research, Christchurch New Zealand
name: Maggie-Lee Huckabee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto Rehabilitation Institute, Toronto Canada
name: Catriona M. Steele, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto, Toronto Canada
name: Pascal van Lieshout, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: