Outcomes of Swallowing Rehabilitation After Stroke

Stroke Clinical Trial

Official title:

Outcomes of Swallowing Rehabilitation After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288834
• Other study ID #: HSF NA 4992
• Secondary ID: NZ CMRF 01/10
• Status: Completed
• Phase: N/A
• First received: February 6, 2006
• Last updated: February 6, 2006
• Start date: August 2001
• Est. completion date: July 2006

Study information

• Verified date: February 2006
• Source: University of Canterbury
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health Research Council
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Dysphagia
• Stroke

Intervention

Behavioral:
• dysphagia rehabilitation

Locations

Country	Name	City	State
Australia	Fremantle Hospital	Fremantle	Western Australia
Australia	Austin and Repatriation Medical Centre	Melbourne	Victoria
Canada	Glenrose Rehabilitation Centre	Edmonton	Alberta
Canada	Hamilton Health Sciences Centre	Hamilton	Ontario
Canada	Trillium Health Centre	Mississauga	Ontario
Canada	Leonard Miller Rehabilitation Centre	St. John's	Newfoundland and Labrador
Canada	Deer Lodge Centre	Winnipeg	Manitoba
New Zealand	Princess Margaret Hospital	Christchurch
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (5)

Lead Sponsor	Collaborator
University of Canterbury	Austin Hospital, Melbourne Australia, Fremantle Hospital and Health Service, Tan Tock Seng Hospital, University of Toronto

Countries where clinical trial is conducted

Australia,  Canada,  New Zealand,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The following outcomes measures will be assessed after 10. 20 and 30 therapeutic sessions:
Primary	Severity rankings of swallowing pathophysiology based on videofluoroscopic swallowing studies Videofluoroscopic swallowing studies
Primary	Functional outcome ratings of associated clinical parameters (respiratory, neurological status, self help, cognitive)
Primary	Quality of life ratings (SwalQOL) In addition, quality of life ratings (SwalQOL) will be assessed at one follow-up assessment six months post discharge.