Study of Tongue Strengthening for Swallowing Problems
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01570023|
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : October 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Dysphagia||Behavioral: Isometric Progressive Resistance Oropharyngeal Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Between Isometric Lingual Strengthening Exercises and Standard Clinical Care for the Treatment of Dysphagia|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
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.
- Change in Swallow Function [ Time Frame: Baseline and 8 Weeks ]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.
- Change in Penetration/Aspiration Scale score [ Time Frame: Baseline and Week 8 ]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 ]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 ]Durational measures of bolus flow through the oropharynx from videofluoroscopic images.
- Change in Isometric Lingual Pressure [ Time Frame: Baseline and 8 Weeks ]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 ]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.
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): NCT01570023
|United States, Illinois|
|Evanston, Illinois, United States, 60208|
|United States, Kentucky|
|Central Baptist Hospital|
|Lexington, Kentucky, United States, 40503|
|United States, Minnesota|
|Minneapolis Veterans Administration Health Care System|
|Minneapolis, Minnesota, United States, 55417|
|United States, New York|
|Silvercrest Center for Nursing and Rehabilitation|
|Briarwood, New York, United States, 11435|
|New York Hospital Queens|
|Flushing, New York, United States, 11355|
|Beth Israel Medical Center|
|New York, New York, United States, 10003|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center Passavant|
|Pittsburgh, Pennsylvania, United States, 15237|
|University of Pittsburgh Medical Center Presbyterian University Hospital|
|Pittsburgh, Pennsylvania, United States, 15237|
|United States, Tennessee|
|VA Medical Center-Memphis|
|Memphis, Tennessee, United States, 38104|
|Principal Investigator:||JoAnne Robbins, PhD||University of Wisconsin, Madison|