Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01570023
Other study ID # 2011-0518
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03711474 - Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal) Phase 4
Enrolling by invitation NCT04074356 - Non-invasive Markers of Esophageal Function in Adults N/A
Suspended NCT04349462 - Post Critical Illness Dysphagia in the Intensive Care Unit N/A
Not yet recruiting NCT05982977 - Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke N/A
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Active, not recruiting NCT03455608 - PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer N/A
Active, not recruiting NCT03604822 - Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS N/A
Recruiting NCT03682081 - Interventions for Patients With Alzheimer's Disease and Dysphagia N/A
Completed NCT05700838 - Refining Cough Skill Training in Parkinson's Disease and Dysphagia Phase 1
Not yet recruiting NCT04064333 - Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care N/A
Completed NCT02927691 - Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial Phase 2
Not yet recruiting NCT02724761 - Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion N/A
Completed NCT01919112 - Fostering Eating After Stroke With Transcranial Direct Current Stimulation N/A
Completed NCT01370083 - Tongue Pressure Profile Training for Dysphagia Post Stroke Phase 2
Completed NCT01723358 - Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia Phase 2
Withdrawn NCT01200147 - Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation N/A
Completed NCT00570557 - Development of a Web-Based Course to Maintain Skills in Nurses Trained to Screen for Dysphagia N/A
Recruiting NCT00166751 - Sonographic Assessment of Laryngeal Elevation N/A
Completed NCT01476241 - Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist N/A
Completed NCT00717028 - Functional Endoscopic Evaluation of Swallowing N/A