Dysphagia Clinical Trial
Official title:
Comparison Between Isometric Lingual Strengthening Exercises and Standard Clinical Care for the Treatment of Dysphagia
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 95 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Silvercrest Center for Nursing and Rehabilitation | Briarwood | New York |
United States | Northwestern University | Evanston | Illinois |
United States | New York Hospital Queens | Flushing | New York |
United States | Central Baptist Hospital | Lexington | Kentucky |
United States | VA Medical Center-Memphis | Memphis | Tennessee |
United States | Minneapolis Veterans Administration Health Care System | Minneapolis | Minnesota |
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 |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline and 8 Weeks | No |
Secondary | 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. | Baseline and Week 8 | No |
Secondary | 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. | Baseline and Week 8 | No |
Secondary | Change in Bolus Transit Times | Durational measures of bolus flow through the oropharynx from videofluoroscopic images. | Baseline and 8 Weeks | No |
Secondary | Change in Isometric Lingual Pressure | Maximum tongue press measured using the FDA registered Madison Oral Strenthening Therapeutic (MOST) device. | Baseline and 8 Weeks | No |
Secondary | 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. | Baseline and 8 Weeks | No |
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