Study of Tongue Strengthening for Swallowing Problems

Dysphagia Clinical Trial

Official title:

Comparison Between Isometric Lingual Strengthening Exercises and Standard Clinical Care for the Treatment of Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570023
• Other study ID #: 2011-0518
• Status: Completed
• Phase: N/A
• First received: March 27, 2012
• Last updated: October 9, 2015
• Start date: April 2012
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

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