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Treatment of Dysphagia Using the Mendelsohn Maneuver

Primary Purpose

Stroke, Dysphagia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mendelsohn Maneuver
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Deglutition Disorders, Mendelsohn Maneuver, SEMG

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stroke (1-18 months post)
  • Pharyngeal Dysphagia

Exclusion Criteria:

  • Other neurologic or structural abnormality to oropharynx
  • History of dysphagia prior to latest stroke

Sites / Locations

  • UArkansas/UAMS Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Within subjects treatment, no-treatment

Arm Description

Within subject, treatment and no-treatment periods. Each participant served as his/her own control in this AABB/BBAA alternating treatment conditions design. Results were also compared across groups (treatment v. no-treatment).

Outcomes

Primary Outcome Measures

Change in Duration of Superior Hyolaryngeal Movement
Change in duration of superior elevation of hyoid bone.
Change in Duration of Hyoid Maximum Anterior Excursion
Change in the duration of maximum anterior movement of the hyoid bone during swallowing.

Secondary Outcome Measures

Change in Oral Intake Ability
Oral Intake Ability was measure with the Dysphagia Outcome and Severity Scale. A 7 is normal and a 1 is complete inability to consume any food safely. The means reported for treatment and no treatment periods are mean changes in scores throughout the period.
Change in Duration of Opening of Upper Esophageal Sphincter
Change in duration of pre- and post-treatment duration of UES opening.

Full Information

First Posted
December 27, 2007
Last Updated
February 21, 2018
Sponsor
University of Arkansas
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT00592761
Brief Title
Treatment of Dysphagia Using the Mendelsohn Maneuver
Official Title
Treatment of Dysphagia Using the Mendelsohn Maneuver
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia.
Detailed Description
The primary goal of the investigation is to determine the effects of the Mendelsohn maneuver (voluntary prolongation of laryngeal excursion at the midpoint of the swallow) on the physiology of the swallow in individuals who have suffered a stroke and exhibit signs of pharyngeal dysphagia (specifically, reduced duration of hyoid maximum elevation, reduced extent of hyoid maximum elevation, reduced duration of hyoid maximum anterior excursion, reduced extent of hyoid maximum anterior excursion, and reduced duration of upper esophageal sphincter (UES) opening with subsequent residue in the pyriform sinuses and, potentially, aspiration). Participants are assessed with videofluoroscopy at the initiation of the study and after each week of the study. After the 4 weeks of participation are complete, all participants will be discharged from treatment and will be brought back to the clinic for a final Videofluoroscopic Swallow Study (VFSS) evaluation after 2 weeks. This means that individuals in Group 1 will be re-analyzed after 1 month of additional no-treatment, and Group 2 will be re-analyzed after 2 additional weeks of no-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Dysphagia
Keywords
Deglutition Disorders, Mendelsohn Maneuver, SEMG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Within subjects treatment, no-treatment
Arm Type
Experimental
Arm Description
Within subject, treatment and no-treatment periods. Each participant served as his/her own control in this AABB/BBAA alternating treatment conditions design. Results were also compared across groups (treatment v. no-treatment).
Intervention Type
Behavioral
Intervention Name(s)
Mendelsohn Maneuver
Intervention Description
Mendelsohn Maneuver with Surface Electromyography
Primary Outcome Measure Information:
Title
Change in Duration of Superior Hyolaryngeal Movement
Description
Change in duration of superior elevation of hyoid bone.
Time Frame
baseline and six weeks
Title
Change in Duration of Hyoid Maximum Anterior Excursion
Description
Change in the duration of maximum anterior movement of the hyoid bone during swallowing.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in Oral Intake Ability
Description
Oral Intake Ability was measure with the Dysphagia Outcome and Severity Scale. A 7 is normal and a 1 is complete inability to consume any food safely. The means reported for treatment and no treatment periods are mean changes in scores throughout the period.
Time Frame
Baseline and 6 weeks
Title
Change in Duration of Opening of Upper Esophageal Sphincter
Description
Change in duration of pre- and post-treatment duration of UES opening.
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stroke (1-18 months post) Pharyngeal Dysphagia Exclusion Criteria: Other neurologic or structural abnormality to oropharynx History of dysphagia prior to latest stroke
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary H McCullough, Ph.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UArkansas/UAMS Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72035
Country
United States

12. IPD Sharing Statement

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Treatment of Dysphagia Using the Mendelsohn Maneuver

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