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External Pharyngeal Exerciser and Dysphagia

Primary Purpose

Dysphagia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharyngeal exerciser
sham pharyngeal exerciser
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with dysphagia characterized by persistent pharyngeal residue on fluoroscopic study undergoing rehabilitative intervention (e.g.: exercises, maneuvers or dietary modification) for improving swallowing and preventing aspiration Healthy elderly adult (≥65 years of age). Exclusion Criteria: Patients younger than 18 years of age. Patients with recent head and neck cancer (<1 month post-surgery or <3 months post-chemo radiation. Patients suffering from muscle diseases like muscular dystrophies, myopathies. Patients with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders Patients having history of allergy to lidocaine or barium. Patients who are pregnant or lactating. Patients who are medically unstable. Patients who are unable to apply the exerciser independently or with the help of a caregiver. Patients who lack cognition.

Sites / Locations

  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Pharyngeal exerciser group

Sham exerciser group

Arm Description

In this group, the device will be placed around the neck overlying the laryngeal cartilage. Patients are asked to follow exercise regimen: to perform 30 swallows at 15 seconds interval against minimal resistance of 20 mm Hg applied by pharyngeal exerciser over larynx during the first 2 weeks. This is repeated 3 times per day and the external resistance is increased every 2 weeks from 20 to 30 mm Hg and subsequently from 30 to 40 mm Hg in another 2 weeks.

In this group, sham device will be placed around the neck overlying the laryngeal cartilage. No external pressure will be applied during exercise. These patients will be asked to follow the exercise regimen: to perform repetitive tongue protrusion for 5 times without any pressure. This will be repeated 3 times a day for 6 weeks.

Outcomes

Primary Outcome Measures

maximum anterior hyoid excursion
deglutitive maximum anterior hyoid excursion from resting position measured from fluoroscopic images
maximum anterior hyoid excursion
deglutitive maximum anterior hyoid excursion from resting position measured from fluoroscopic images
maximum superior hyoid excursion
deglutitive maximum superior hyoid excursion from resting position measured from fluoroscopic images
maximum superior hyoid excursion
deglutitive maximum superior hyoid excursion from resting position measured from fluoroscopic images
maximum anterior laryngeal excursion
deglutitive maximum anterior laryngeal excursion from resting position measured from fluoroscopic images
maximum anterior laryngeal excursion
deglutitive maximum anterior laryngeal excursion from resting position measured from fluoroscopic images
maximum superior laryngeal excursion
deglutitive maximum superior laryngeal excursion from resting position measured from fluoroscopic images
maximum superior laryngeal excursion
deglutitive maximum superior laryngeal excursion from resting position measured from fluoroscopic images
maximum upper esophageal sphincter (UES) anterior-posterior opening
deglutitive maximum UES diameter measured from fluoroscopic images
maximum upper esophageal sphincter (UES) anterior-posterior opening
deglutitive maximum UES diameter measured from fluoroscopic images
pyriform sinus residue
area (height x width) of pyriform sinus residue measure from fluoroscopic images
pyriform sinus residue
area (height x width) of pyriform sinus residue measure from fluoroscopic images

Secondary Outcome Measures

Penetration and aspiration analyses
Reduction of aspiration and penetration measured by Rosenbek's penetration-aspiration scale
Penetration and aspiration analyses
Reduction of aspiration and penetration measured by Rosenbek's penetration-aspiration scale

Full Information

First Posted
January 13, 2023
Last Updated
January 24, 2023
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT05708898
Brief Title
External Pharyngeal Exerciser and Dysphagia
Official Title
Effect of Pharyngeal Exerciser in Rehabilitation of Pharyngeal Phase of Swallowing in Patients With Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2015 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this a clinical trial is to test the effect of a pharyngeal exerciser in rehabilitation of pharyngeal phase of swallowing in patients with dysphagia. The main question it aims to answer is: •Does application of pharyngeal exerciser improve swallowing as evidenced by need for prescribed intervention for dysphagia (maneuvers, exercises or dietary modification to prevent aspiration). Participants will: Perform barium swallows in lateral view fluoroscopy Over a six-week period, perform thrice daily sessions of swallowing with an external, laryngeal restriction device covering the larynx Return for another fluoroscopic barium swallow study
Detailed Description
All the patients will be reviewed for inclusion and exclusion of the study in detailed manner using medical evaluation form. The physical examination part of the medical evaluation form will be filled out by one of our designated physician investigators. A urine pregnancy test will be administered if necessary at this time. The patient's neck physical dimensions and device's physical dimensions will be measured and recorded using the Biometric form. A baseline functional outcome assessment of swallowing (FOAMS) will be performed for each patient. Patients will be sitting in an upright position with the head held in neutral position at Fluoroscopy lab and acclimatized for 10 minutes before proceeding. Patient's anatomic structure and landmarks are identified in both lateral and anteroposterior (AP) views with fluoroscopy. A 4 mm diameter catheter with 3 markers 3 cm apart will be placed on the skin in the pharyngo-UES region for the purpose of calibration and nullify the error from magnification during videorecording. Patient will be asked to swallow barium suspension at incremental volumes of 1, 3 and 5 ml; however, if the patient develops aspiration or doesn't tolerate barium suspension higher volumes will not be administered. Following are test swallows under fluoroscopy: 1 ml- 40% weight/volume barium suspension at room temperature x 3 times each. 3 ml- 40% weight/volume barium suspension at room temperature x 3 times each. 5 ml- 40% weight/volume barium suspension at room temperature x 3 times each. The fluoroscopy machine will be turned "on" for 5 seconds ONLY during each swallow. Rest of the time fluoroscopy machine will be turned "off". Fluoroscopic recordings were obtained at 90 kilo-electron-volt (KeV), using a 9-inch image-intensifier mode and appropriate collimation so that an image was obtained of the posterior mouth, pharynx, and pharyngoesophageal region. Fluoroscopic recordings will be timed using a specially designed timer. After the baseline fluoroscopic study, each patient will be randomized to receive either the sham exerciser (i.e. device with no pressure) or pharyngeal exerciser (i.e. device with graded pressure). Study Groups: Pharyngeal exerciser group: In this group, the device will be placed around the neck overlying the laryngeal cartilage. The device will be in contact with the skin without any underlying pressure using the Velcro fastening in the back of neck. The externally applied pressure will be measured by means of the pressure gauge included in the device (see figure). Patients are asked to follow exercise regimen: to perform 30 swallows at 15 seconds interval against minimal resistance of 20 mm Hg applied by pharyngeal exerciser over larynx during the first 2 weeks. This is repeated 3 times per day and the external resistance is increased every 2 weeks from 20 to 30 mm Hg and subsequently from 30 to 40 mm Hg in another 2 weeks. Sham exerciser group: In this group, sham device will be placed around the neck overlying the laryngeal cartilage. No external pressure will be applied during exercise. These patients will be asked to follow the exercise regimen: to perform repetitive tongue protrusion for 5 times without any pressure. This will be repeated 3 times a day for 6 weeks. All the exercise instructions and log record will be given to each of the patient in both study groups at the time of randomization. The exerciser (sham or pharyngeal) will be worn only at the time of exercises. Weekly telephone interviews will be conducted to assess their progress and address their concerns in both study groups. Patients in both study groups are required to make follow up visits every 2 weeks. During the follow up visits, patients will be reviewed for symptom severity and resistance of the device. This information is documented in patient progress sheet and follow up visit form. All the adverse events during the study or from the device will be documented in the adverse and serious adverse events form. The compliance with the device will be evaluated by examining the exercise log sheet. After 6 weeks, the device (sham exerciser or pharyngeal exerciser) will be returned to the study team and patients will be asked to complete functional outcome assessment of swallowing (FOAMS). Each patient will undergo follow up fluoroscopic study with the same test swallows as the baseline swallows, looking for pharyngeal residue and aspiration (repeat steps: 4 to 9). All the fluoroscopic images will be recorded and stored in digitalized format at 30 frames (60 fields/second) in a secure location at the research lab (locked in safe location and accessible only to the investigators). These the fluoroscopic studies will be analyzed for the study parameters as mentioned below by two individuals in a blinded fashion. At the end of study period, each of the patients in sham group will be given an option to undergo another 6 weeks of pharyngeal exercise using pharyngeal exerciser. If they consent again(using informed consent form) to participate, they would be following above exercise protocol(30 swallows against 20 mm Hg of resistance with pharyngeal exerciser three times a day for 2 weeks; followed by swallowing exercise with incremental resistance of 30 and 40 mm Hg for 2 weeks each). At of 6 weeks, they would undergo repeat fluoroscopy study to check for improvement in pharyngeal residue (repeat steps: 4 to 9). The participants will be followed after completion of the exercise regimen for a total of 12 months. At 3 months after the completion of initial exercise study, the participant will be contacted and informed about the follow up portion of the study. If they are in agreement, the participant will be asked to come to the lab to be reconsented and complete an EAT-10 form. At this time, the participant will be asked questions such as current diet consistency, evidence of cough with eating, additional time needed during meals, etc to determine FOAMS score. The patient will only be interviewed after consent is obtained. At 6 months, the subjects will undergo repeat fluoroscopy for an objective measure of their swallowing. At this visit they will also be asked to complete an EAT-10 form and a FOAMS score will again be determined. At 12 months, the participant will not be required to return to the lab. They will also be mailed a swallowing assessment form (EAT-10) to be filled out and returned at 12 months (subjects will be asked to complete the paper form for consistency). The participant will also be contacted for a telephone interview to be asked questions such as current diet consistency, evidence of cough with eating, additional time needed during meals, etc to determine FOAMS score. For those subjects who are newly enrolled, re-consent will not occur since there is only one consent form which includes the follow-up information. Newly enrolled subjects will be presented with the follow-up information at the time of initial consent. During the entire study period, the participant will be instructed to continue their standard of medical care (medications, diet, physical therapy and activity) as suggested by their personnel physician. All the fluoroscopic studies will be analyzed by two individuals in a blinded fashion. After the completion of the study, individuals in the sham exerciser group will be given the option of doing exercises using pharyngeal exerciser. If they are interested, consent will be obtained using new consent form before re-enrolling into the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pharyngeal exerciser group: In this group, the device will be placed around the neck overlying the laryngeal cartilage using the Velcro fastening in the back of neck. The externally applied pressure will be measured via the pressure gauge included in the device (see figure). Patients are asked to follow exercise regimen: to perform 30 swallows at 15 seconds interval against minimal resistance of 20 mm Hg applied by pharyngeal exerciser over larynx during the first 2 weeks. This is repeated 3 times per day and the external resistance is increased every 2 weeks from 20 to 30 mm Hg and subsequently from 30 to 40 mm Hg in another 2 weeks. Sham exerciser group: In this group, sham device will be placed around the neck overlying the laryngeal cartilage. No external pressure will be applied during exercise. These patients will be asked to follow the exercise regimen: to perform repetitive tongue protrusion for 5 times without any pressure. This will be repeated 3 times a day for 6 weeks.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharyngeal exerciser group
Arm Type
Experimental
Arm Description
In this group, the device will be placed around the neck overlying the laryngeal cartilage. Patients are asked to follow exercise regimen: to perform 30 swallows at 15 seconds interval against minimal resistance of 20 mm Hg applied by pharyngeal exerciser over larynx during the first 2 weeks. This is repeated 3 times per day and the external resistance is increased every 2 weeks from 20 to 30 mm Hg and subsequently from 30 to 40 mm Hg in another 2 weeks.
Arm Title
Sham exerciser group
Arm Type
Sham Comparator
Arm Description
In this group, sham device will be placed around the neck overlying the laryngeal cartilage. No external pressure will be applied during exercise. These patients will be asked to follow the exercise regimen: to perform repetitive tongue protrusion for 5 times without any pressure. This will be repeated 3 times a day for 6 weeks.
Intervention Type
Device
Intervention Name(s)
Pharyngeal exerciser
Intervention Type
Device
Intervention Name(s)
sham pharyngeal exerciser
Primary Outcome Measure Information:
Title
maximum anterior hyoid excursion
Description
deglutitive maximum anterior hyoid excursion from resting position measured from fluoroscopic images
Time Frame
Before six weeks exerciser regimen
Title
maximum anterior hyoid excursion
Description
deglutitive maximum anterior hyoid excursion from resting position measured from fluoroscopic images
Time Frame
after six weeks exerciser regimen
Title
maximum superior hyoid excursion
Description
deglutitive maximum superior hyoid excursion from resting position measured from fluoroscopic images
Time Frame
Before six weeks exerciser regimen
Title
maximum superior hyoid excursion
Description
deglutitive maximum superior hyoid excursion from resting position measured from fluoroscopic images
Time Frame
after six weeks exerciser regimen
Title
maximum anterior laryngeal excursion
Description
deglutitive maximum anterior laryngeal excursion from resting position measured from fluoroscopic images
Time Frame
Before six weeks exerciser regimen
Title
maximum anterior laryngeal excursion
Description
deglutitive maximum anterior laryngeal excursion from resting position measured from fluoroscopic images
Time Frame
after six weeks exerciser regimen
Title
maximum superior laryngeal excursion
Description
deglutitive maximum superior laryngeal excursion from resting position measured from fluoroscopic images
Time Frame
before six weeks exerciser regimen
Title
maximum superior laryngeal excursion
Description
deglutitive maximum superior laryngeal excursion from resting position measured from fluoroscopic images
Time Frame
after six weeks exerciser regimen
Title
maximum upper esophageal sphincter (UES) anterior-posterior opening
Description
deglutitive maximum UES diameter measured from fluoroscopic images
Time Frame
Before six weeks exerciser regimen
Title
maximum upper esophageal sphincter (UES) anterior-posterior opening
Description
deglutitive maximum UES diameter measured from fluoroscopic images
Time Frame
after six weeks exerciser regimen
Title
pyriform sinus residue
Description
area (height x width) of pyriform sinus residue measure from fluoroscopic images
Time Frame
Before six weeks exerciser regimen
Title
pyriform sinus residue
Description
area (height x width) of pyriform sinus residue measure from fluoroscopic images
Time Frame
after six weeks exerciser regimen
Secondary Outcome Measure Information:
Title
Penetration and aspiration analyses
Description
Reduction of aspiration and penetration measured by Rosenbek's penetration-aspiration scale
Time Frame
Before six weeks exerciser regimen
Title
Penetration and aspiration analyses
Description
Reduction of aspiration and penetration measured by Rosenbek's penetration-aspiration scale
Time Frame
after six weeks exerciser regimen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with dysphagia characterized by persistent pharyngeal residue on fluoroscopic study undergoing rehabilitative intervention (e.g.: exercises, maneuvers or dietary modification) for improving swallowing and preventing aspiration Healthy elderly adult (≥65 years of age). Exclusion Criteria: Patients younger than 18 years of age. Patients with recent head and neck cancer (<1 month post-surgery or <3 months post-chemo radiation. Patients suffering from muscle diseases like muscular dystrophies, myopathies. Patients with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders Patients having history of allergy to lidocaine or barium. Patients who are pregnant or lactating. Patients who are medically unstable. Patients who are unable to apply the exerciser independently or with the help of a caregiver. Patients who lack cognition.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reza Shaker, MD
Phone
4149556840
Email
rshaker@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Kern
Phone
414-805-3826
Email
mkern@mcw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Shaker, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53086
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
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External Pharyngeal Exerciser and Dysphagia

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