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Exercise for Swallowing Problems After Stroke

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ClinicalTrials.gov Identifier: NCT00722111
Recruitment Status : Completed
First Posted : July 25, 2008
Results First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Cerebrovascular Accident Deglutition Disorders Device: lingual press Behavioral: effortful swallowing Behavioral: natural swallowing Behavioral: non-oral sham (control) exercise Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rehabilitation Exercise for Dysphagia Subsequent to Stroke
Study Start Date : February 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
lingual press (high-intensity, oral, non-swallowing)
Device: lingual press
lingual press (high-intensity, oral, non-swallowing)
Experimental: Arm 2
effortful swallowing (high-intensity swallowing)
Behavioral: effortful swallowing
effortful swallowing (high-intensity swallowing)
Experimental: Arm 3
natural swallowing (high frequency, low intensity swallowing)
Behavioral: natural swallowing
natural swallowing (high frequency, low intensity swallowing)
Sham Comparator: Arm 4
non-oral sham (control) exercise
Behavioral: non-oral sham (control) exercise
non-oral sham (control) exercise



Primary Outcome Measures :
  1. Isometric Lingual Pressure [ Time Frame: 8 weeks ]
    Tongue Strength

  2. Maximum Isometric Tongue Pressure [ Time Frame: 16 months ]
    Peak isometric pressure at 4 sensors



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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 congestive heart failure
  • sever chronic 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722111


Locations
United States, Wisconsin
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
VA Office of Research and Development
University of Wisconsin, Madison
Investigators
Principal Investigator: JoAnne Robbins, PhD Wlliam S. Middleton Memorial Veterans Hospital, Madison

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00722111     History of Changes
Other Study ID Numbers: C4796-R
First Posted: July 25, 2008    Key Record Dates
Results First Posted: March 21, 2018
Last Update Posted: March 21, 2018
Last Verified: March 2018

Keywords provided by VA Office of Research and Development:
tongue
pressure

Additional relevant MeSH terms:
Stroke
Deglutition Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases