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Completed

NCT Number: NCT00592761

Treatment of Dysphagia Using the Mendelsohn Maneuver

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UArkansas/UAMS Medical Center

Little Rock, Arkansas, 72035, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mendelsohn Maneuver

Behavioral

Mendelsohn Maneuver with Surface Electromyography

Primary outcomes

  1. Change in Duration of Superior Hyolaryngeal Movement

    Time frame: baseline and six weeks

    Change in duration of superior elevation of hyoid bone.

  2. Change in Duration of Hyoid Maximum Anterior Excursion

    Time frame: Baseline and 6 weeks

    Change in the duration of maximum anterior movement of the hyoid bone during swallowing.

Secondary outcomes

  1. Change in Oral Intake Ability

    Time frame: Baseline and 6 weeks

    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.

  2. Change in Duration of Opening of Upper Esophageal Sphincter

    Time frame: Baseline and 6 weeks

    Change in duration of pre- and post-treatment duration of UES opening.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jan 14, 2008
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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