Treatment of Dysphagia Using the Mendelsohn Maneuver

NCT ID: NCT00592761

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2008-09-30

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.

Conditions

Stroke; Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Within subjects treatment, no-treatment

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).

Group Type: EXPERIMENTAL

Mendelsohn Maneuver

Intervention Type: BEHAVIORAL

Mendelsohn Maneuver with Surface Electromyography

Interventions

Mendelsohn Maneuver

Mendelsohn Maneuver with Surface Electromyography

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary H McCullough, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

UArkansas/UAMS Medical Center

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

R03DC004942

Identifier Type: NIH

Identifier Source: secondary_id

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R03DC004942

Identifier Type: NIH

Identifier Source: org_study_id

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