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Treatment of Dysphagia Using the Mendelsohn Maneuver

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00592761
First received: December 27, 2007
Last updated: July 27, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Stroke
Dysphagia
Behavioral: Mendelsohn Maneuver
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Dysphagia Using the Mendelsohn Maneuver

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Change in Duration of Superior Hyolaryngeal Movement [ Time Frame: baseline and six weeks ] [ Designated as safety issue: No ]
    Change in duration of superior elevation of hyoid bone.

  • Change in Duration of Hyoid Maximum Anterior Excursion [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Change in the duration of maximum anterior movement of the hyoid bone during swallowing.


Secondary Outcome Measures:
  • Change in Oral Intake Ability [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Change in duration of pre- and post-treatment duration of UES opening.


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
Experimental: 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).
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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Gary H. McCullough, UArkansas
ClinicalTrials.gov Identifier: NCT00592761     History of Changes
Other Study ID Numbers: R03 DC004942, R03DC004942
Study First Received: December 27, 2007
Results First Received: January 25, 2010
Last Updated: July 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Deglutition Disorders
Mendelsohn Maneuver
SEMG

Additional relevant MeSH terms:
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Otorhinolaryngologic Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on November 25, 2014