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OpenTrials
Completed

NCT Number: NCT01570023

Study of Tongue Strengthening for Swallowing Problems

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.

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Key information

Conditions

Dysphagia Behavior Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Motor Activity Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

21 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Evanston, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Isometric Progressive Resistance Oropharyngeal Therapy

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Change in Bolus Transit Times

    Time frame: Baseline and 8 Weeks

    Durational measures of bolus flow through the oropharynx from videofluoroscopic images.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2012
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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