Treatment of Dysphagia Using the Mendelsohn Maneuver

Stroke Clinical Trial

Official title:

Treatment of Dysphagia Using the Mendelsohn Maneuver

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592761
• Other study ID #: R03DC004942
• Secondary ID: R03DC004942
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 27, 2007
• Last updated: February 21, 2018
• Start date: July 2003
• Est. completion date: September 2008

Study information

• Verified date: February 2018
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Stroke

Intervention

Behavioral:
• Mendelsohn Maneuver
Mendelsohn Maneuver with Surface Electromyography

Locations

Country	Name	City	State
United States	UArkansas/UAMS Medical Center	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Duration of Superior Hyolaryngeal Movement	Change in duration of superior elevation of hyoid bone.	baseline and six weeks
Primary	Change in Duration of Hyoid Maximum Anterior Excursion	Change in the duration of maximum anterior movement of the hyoid bone during swallowing.	Baseline and 6 weeks
Secondary	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.	Baseline and 6 weeks
Secondary	Change in Duration of Opening of Upper Esophageal Sphincter	Change in duration of pre- and post-treatment duration of UES opening.	Baseline and 6 weeks