Exercise for Swallowing Problems After Stroke

This study has been completed.
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00722111
First received: July 23, 2008
Last updated: September 27, 2013
Last verified: September 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rehabilitation Exercise for Dysphagia Subsequent to Stroke

Resource links provided by NLM:


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 ]

Enrollment: 200
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00722111     History of Changes
Other Study ID Numbers: C4796-R
Study First Received: July 23, 2008
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
tongue
pressure

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

ClinicalTrials.gov processed this record on October 30, 2014