Treatment of Dysphagia Using the Mendelsohn Maneuver - Full Text View

Sponsored by:	University of Arkansas
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00592761

Purpose

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 VFS 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.

Condition	Intervention	Phase
Stroke Dysphagia	Behavioral: Mendelsohn Maneuver	Phase I Phase II

MedlinePlus related topics: Esophagus Disorders Swallowing Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment of Dysphagia Using the Mendelsohn Maneuver

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Hyolaryngeal Movement [ Time Frame: End of Study ] [ Designated as safety issue: No ]
Upper Esophageal Sphincter Opening [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Oral Intake Ability [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	18
Study Start Date:	July 2003
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Active Comparator Self-control, treatment and no-treatment periods.	Behavioral: Mendelsohn Maneuver Mendelsohn Maneuver with Surface Electromyography

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 VFS 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592761

Locations

United States, Arkansas
UArkansas/UAMS Medical Center
Little Rock, Arkansas, United States, 72035

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:

Gary H McCullough, Ph.D.

University of Arkansas

More Information

No publications provided

Responsible Party:	UArkansas ( Gary H. McCullough )
Study ID Numbers:	R03 DC004942, R03 DC004942
Study First Received:	December 27, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00592761 History of Changes
Health Authority:	United States: National Institutes of Health

Keywords provided by University of Arkansas:

Deglutition Disorders
Mendelsohn Maneuver
SEMG

Study placed in the following topic categories:

Deglutition Disorders
Otorhinolaryngologic Diseases
Digestive System Diseases
Cerebral Infarction
Esophageal Disorder

Gastrointestinal Diseases
Stroke
Esophageal Diseases
Pharyngeal Diseases

Additional relevant MeSH terms:

Deglutition Disorders
Otorhinolaryngologic Diseases
Digestive System Diseases

Gastrointestinal Diseases
Esophageal Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on May 07, 2009