Study of Tongue Strengthening for Swallowing Problems

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Wisconsin, Madison.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01570023
First received: March 27, 2012
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

This study is a multisite, randomized clinical trial to determine the effectiveness of an 8-week rehabilitative exercise regime performed by patients with swallowing problems, termed dysphagia, compared to a control group of patients with swallowing problems who do not exercise, but receive standard clinical care. One hundred male and female patients will take part in this study from eight participating facilities around the country.


Condition Intervention
Dysphagia
Behavioral: Isometric Progressive Resistance Oropharyngeal Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between Isometric Lingual Strengthening Exercises and Standard Clinical Care for the Treatment of Dysphagia

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Change in Swallow Function [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
    The Primary Outcome will be objectively measured from videofluoroscopic images. Improvement in swallowing is defined as a reduction in either the average Penetration/Aspiration scale score or the average Residue Scale score over the 11 swallows (3 3-ml thin liquid, 3 10-ml thin liquid, 3 3-ml semi-solid and 2 3-ml thin liquid effortful) combined with no increase in the other average score. If the series of swallows is terminated prematurely, the worst possible score (8 for Penetration/Aspiration Scale, 2 for residue) will be assigned for all uncompleted swallows.


Secondary Outcome Measures:
  • Change in Penetration/Aspiration Scale score [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    An 8-point scale indicating occurrence, depth, clearance and patient response to material invading the laryngeal vestibule or trachea. The Penetration/Aspiration Scale score will be objectively measured from videofluoroscopic images.

  • Change in Residue Scale score [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    A 3-point scale to measure post-swallow barium residue on a videofluoroscopic image. The Residue Scale score will be objectively measured from videofluoroscopic images.

  • Change in Bolus Transit Times [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
    Durational measures of bolus flow through the oropharynx from videofluoroscopic images.

  • Change in Isometric Lingual Pressure [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
    Maximum tongue press measured using the FDA registered Madison Oral Strenthening Therapeutic (MOST) device.

  • Change in Quality of Life [ Time Frame: Baseline and 8 Weeks ] [ Designated as safety issue: No ]
    Each subject will complete a questionnaire detailing his/her quantity and variety of nutritional intake and also will complete a questionnaire (Swal-Qol) about the impact of dysphagia on his/her quality of life at baseline and week 8. It takes approximately 10 minutes to complete each questionnaire.


Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Clinical Care
Standard swallowing intervention is that which is identified by the SLP as appropriate to treat the patient's dysphagia and is in common clinical practice. Such treatment would consist of dietary or postural compensatory strategies (i.e., chin down posture while swallowing).
Experimental: Standard Clinical Care Plus Isometric Lingual Exercise
Standard Clinical Care Plus 8-week Isometric Lingual Exercise Regimen. The isometric tongue exercises will be completed using the Madison Oral Strengthening Therapeutic (MOST) device. Baseline maximum lingual pressure will be obtained at the anterior and posterior sensors independently by gathering two sets of data (3 MOST device trials) at each site (anterior and posterior) that differ by less that 5%. During week one of the regimen, the target value of each repetition will be 60% of the maximum baseline pressure. For the remaining seven weeks of the program, the target value will be increased to 80% of the maximum. At weeks three, five, and seven, the baseline will be re-measured by phone and the 80% target value re-calculated.
Behavioral: Isometric Progressive Resistance Oropharyngeal Therapy
Tongue press exercises consist of pressing the tongue against the sensors. Isometric exercises will focus on the anterior and posterior sensor. Subjects will be given a target pressure value for both the anterior and posterior sensor locations for which to aim when doing the exercises. Visual feedback on the display will signal the subject that they have attained their target pressure goal.

  Eligibility

Ages Eligible for Study:   21 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • referral by a physician for swallowing evaluation because of suspected dysphagia
  • complaint of difficulty swallowing
  • aspiration or penetration of the laryngeal vestibule with liquids or semisolids OR post-swallow residue visible in the oral cavity, valleculae, or pharynx that is instrumentally documented by a participating SLP during a standard clinical videofluoroscopic swallowing study
  • between the ages of 21 and 95
  • ability to perform the exercise protocol independently or with the assistance of a caregiver
  • physician approval of medical stability to participate
  • decision-making capacity to provide informed consent (confirmed through discussion between the participating SLP and the subject's primary physician)

Exclusion Criteria:

  • degenerative neuromuscular disease
  • poorly controlled psychosis
  • patient unable to complete the exercise program
  • allergy to barium (used in videofluoroscopic swallowing assessment)
  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: NCT01570023

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

Locations
United States, Illinois
Northwestern University Not yet recruiting
Evanston, Illinois, United States, 60208
Contact: Jeri Logemann, PhD    847-491-2490    j-logemann@northwestern.edu   
United States, Kentucky
Central Baptist Hospital Not yet recruiting
Lexington, Kentucky, United States, 40503
Contact: Nancy Swigert, MA    859-260-6142    Nswigert@bhsi.com   
United States, Minnesota
Minneapolis Veterans Administration Health Care System Not yet recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Steve Kosek, MS    612-467-4462    steven.kosek@va.gov   
United States, New York
Silvercrest Center for Nursing and Rehabilitation Not yet recruiting
Briarwood, New York, United States, 11435
Contact: Karen Dikeman, MA    718-480-4008      
New York Hospital Queens Not yet recruiting
Flushing, New York, United States, 11355
Contact: Marta Kazandjian, MA       mkazandjian@silvercrest.org   
Beth Israel Medical Center Not yet recruiting
New York, New York, United States, 10003
Contact: Cathy Lazarus, PhD    212-844-6493    clazarus@chpnet.org   
United States, Pennsylvania
University of Pittsburgh Medical Center Passavant Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15237
Contact: James Coyle, PhD    412-383-6608    jcoyle@pitt.edu   
University of Pittsburgh Medical Center Presbyterian University Hospital Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15237
Contact: James Coyle, PhD    412-383-6608    jcoyle@pitt.edu   
United States, Tennessee
VA Medical Center-Memphis Not yet recruiting
Memphis, Tennessee, United States, 38104
Contact: Debra Suiter, PhD    901-523-8990    debra.suiter@va.gov   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: JoAnne Robbins, PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01570023     History of Changes
Other Study ID Numbers: 2011-0518
Study First Received: March 27, 2012
Last Updated: March 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Deglutition
Exercise

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014