Exercise for Swallowing Problems After Stroke - Full Text View

Purpose

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Rehabilitation Exercise for Dysphagia Subsequent to Stroke

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Composite Score of Penetration/Aspiration Scale and Residue Scale with no worsening of either at baseline, week 4, and week 8. These data are collected by videofluoroscopy. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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)	Device: lingual press lingual press (high-intensity, oral, non-swallowing)
2: Experimental effortful swallowing (high-intensity swallowing)	Behavioral: effortful swallowing effortful swallowing (high-intensity swallowing)
3: Experimental natural swallowing (high frequency, low intensity swallowing)	Behavioral: natural swallowing natural swallowing (high frequency, low intensity swallowing)
4: Sham Comparator non-oral sham (control) exercise	Behavioral: non-oral sham (control) exercise non-oral sham (control) exercise

Show Detailed Description

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

3 months post ischemic or hemorrhagic stroke
45 years of age or older
physician approval of medical stability
aspiration or penetration of the laryngeal vestibule (score of 3 or higher on Penetration/Aspiration Scale) or post swallow residue in the oropharynx
able to manage own secretions with no signs of aspiration
the capacity to provide informed consent

Exclusion Criteria:

neurologic insult (other than stroke) or neuromuscular disease
history of radiation to the head or neck
poorly controlled psychosis
lack the capacity to complete the exercise program
refractory alcoholism (on AWD precautions)
class IV congetive heart failure
sever chonic obstructive pulmonary disease (home oxygen dependent)
end-stage renal failure
allergy to barium (used in radiographic swallowing assessment

Subjects with known contraindication will be excluded from the MRI portion of the protocol:

Cardiac pacemakers
Aneurysm clips
Neurostimulators
Cochlear implant
Ossicular prostheses
Intracranial or intraorbital foreign bodies
Claustrophobia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722111

Contacts


Contact: Jacqueline Hind, MS	(608) 256-1901 ext 11125	jahind@wisc.edu

Locations


United States, Wisconsin
	Wlliam S. Middleton Memorial Veterans Hospital, Madison
	Madison, Wisconsin, United States, 53705

Sponsors and Collaborators

Department of Veterans Affairs

University of Wisconsin, Madison

Investigators


Principal Investigator:	Joanne Robbins, PhD	Wlliam S. Middleton Memorial Veterans Hospital, Madison

More Information

Publications of Results:

Nicosia MA, Hind JA, Roecker EB, Carnes M, Doyle J, Dengel GA, Robbins J. Age effects on the temporal evolution of isometric and swallowing pressure. J Gerontol A Biol Sci Med Sci. 2000 Nov;55(11):M634-40.

Robbins J, Coyle J, Rosenbek J, Roecker E, Wood J. Differentiation of normal and abnormal airway protection during swallowing using the penetration-aspiration scale. Dysphagia. 1999 Fall;14(4):228-32.

Robbins J, Kays SA, Gangnon RE, Hind JA, Hewitt AL, Gentry LR, Taylor AJ. The effects of lingual exercise in stroke patients with dysphagia. Arch Phys Med Rehabil. 2007 Feb;88(2):150-8.

Robbins J, Butler SG, Daniels SK, Diez Gross R, Langmore S, Lazarus CL, Martin-Harris B, McCabe D, Musson N, Rosenbek J. Swallowing and dysphagia rehabilitation: translating principles of neural plasticity into clinically oriented evidence. J Speech Lang Hear Res. 2008 Feb;51(1):S276-300.

Other Publications:

Robbins J, Gangnon RE, Theis SM, Kays SA, Hewitt AL, Hind JA. The effects of lingual exercise on swallowing in older adults. J Am Geriatr Soc. 2005 Sep;53(9):1483-9.

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

Keywords provided by Department of Veterans Affairs:

tongue

pressure

Study placed in the following topic categories:

Otorhinolaryngologic Diseases

Esophageal disorder

Cerebral Infarction

Gastrointestinal Diseases

Stroke

Vascular Diseases

Central Nervous System Diseases

Ischemia

Brain Diseases

Pharyngeal Diseases

Cerebrovascular Disorders

Deglutition Disorders

Digestive System Diseases

Brain Ischemia

Esophageal Diseases

Brain Infarction

Infarction

Additional relevant MeSH terms:

Nervous System Diseases

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 24, 2008

Sponsors and Collaborators:	Department of Veterans Affairs University of Wisconsin, Madison
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00722111