Outcomes of Swallowing Rehabilitation After Stroke

Not Applicable

Completed

• Conditions: Stroke; Cerebrovascular Accident; Dysphagia

• Registration Number: NCT00288834
• Lead Sponsor: University of Canterbury

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.

Study Timeline

• Study Start: 2001-08
• Status Verified: 2006-02
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Last Update Submitted: 2006-02-06
• Study First Posted: 2006-02-08
• Last Update Posted: 2006-02-08
• Study Completion: 2006-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (9)

Austin and Repatriation Medical Centre; 🇦🇺 Melbourne, Victoria, Australia

Fremantle Hospital; 🇦🇺 Fremantle, Western Australia, Australia

Glenrose Rehabilitation Centre; 🇨🇦 Edmonton, Alberta, Canada

Deer Lodge Centre; 🇨🇦 Winnipeg, Manitoba, Canada

Leonard Miller Rehabilitation Centre; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

Hamilton Health Sciences Centre; 🇨🇦 Hamilton, Ontario, Canada

Trillium Health Centre; 🇨🇦 Mississauga, Ontario, Canada

Princess Margaret Hospital; 🇳🇿 Christchurch, New Zealand

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore