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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
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.
Northwestern University
Evanston, Illinois, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Minneapolis Veterans Administration Health Care System
Minneapolis, Minnesota, United States
Change in Swallow Function
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.
Time frame: Baseline and 8 Weeks
Change in Penetration/Aspiration Scale score
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.
Time frame: Baseline and Week 8
Change in Residue Scale score
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.
Time frame: Baseline and Week 8
Change in Bolus Transit Times
Durational measures of bolus flow through the oropharynx from videofluoroscopic images.
Time frame: Baseline and 8 Weeks
Change in Isometric Lingual Pressure
Maximum tongue press measured using the FDA registered Madison Oral Strenthening Therapeutic (MOST) device.
Time frame: Baseline and 8 Weeks
Change in Quality of Life
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Silvercrest Center for Nursing and Rehabilitation
Briarwood, New York, United States
New York Hospital Queens
Flushing, New York, United States
Beth Israel Medical Center
New York, New York, United States
University of Pittsburgh Medical Center Passavant
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center Presbyterian University Hospital
Pittsburgh, Pennsylvania, United States
VA Medical Center-Memphis
Memphis, Tennessee, United States
Time frame: Baseline and 8 Weeks