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Sponsors and Collaborators: |
Department of Veterans Affairs University of Wisconsin, Madison |
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00722111 |
The purpose of this study is to determine whether stroke patients with swallowing problems will show greater swallowing improvement with intense oral exercise than subjects who perform either a low intensity oral exercise or a sham exercise.
Condition | Intervention |
Cerebrovascular Accident Deglutition Disorders |
Device: lingual press Behavioral: effortful swallowing Behavioral: natural swallowing Behavioral: non-oral sham (control) exercise |
MedlinePlus related topics: | Exercise and Physical Fitness Rehabilitation Swallowing Disorders |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Rehabilitation Exercise for Dysphagia Subsequent to Stroke |
Estimated Enrollment: | 200 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
lingual press (high-intensity, oral, non-swallowing)
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Device: lingual press
lingual press (high-intensity, oral, non-swallowing)
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2: Experimental
effortful swallowing (high-intensity swallowing)
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Behavioral: effortful swallowing
effortful swallowing (high-intensity swallowing)
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3: Experimental
natural swallowing (high frequency, low intensity swallowing)
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Behavioral: natural swallowing
natural swallowing (high frequency, low intensity swallowing)
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4: Sham Comparator
non-oral sham (control) exercise
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Behavioral: non-oral sham (control) exercise
non-oral sham (control) exercise
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Show Detailed Description |
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with known contraindication will be excluded from the MRI portion of the protocol:
Contact: Jacqueline Hind, MS | (608) 256-1901 ext 11125 | jahind@wisc.edu |
United States, Wisconsin | |||||
Wlliam S. Middleton Memorial Veterans Hospital, Madison | |||||
Madison, Wisconsin, United States, 53705 |
Department of Veterans Affairs |
University of Wisconsin, Madison |
Principal Investigator: | Joanne Robbins, PhD | Wlliam S. Middleton Memorial Veterans Hospital, Madison |
Responsible Party: | Department of Veterans Affairs ( Robbins, Joanne - Principal Investigator ) |
Study ID Numbers: | C4796R |
First Received: | July 23, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00722111 |
Health Authority: | United States: Federal Government |
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