Study of Tongue Strengthening for Swallowing Problems

University of Wisconsin, Madison34 enrolled

Overview

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

Conditions

Dysphagia

Interventions

Isometric Progressive Resistance Oropharyngeal TherapyBEHAVIORAL

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

Sex: ALLMin age: 21 YearsMax age: 95 Years

Medical Language ↔ Plain English

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)

Locations (9)

Northwestern University

Evanston, Illinois, United States

Central Baptist Hospital

Lexington, Kentucky, United States

Minneapolis Veterans Administration Health Care System

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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