Treatment of Dysphagia Using the Mendelsohn Maneuver
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 stroke
Started Jul 2003
Longer than P75 for phase_1 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 27, 2007
CompletedFirst Posted
Study publicly available on registry
January 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
July 20, 2010
CompletedMarch 20, 2018
February 1, 2018
5.2 years
December 27, 2007
January 25, 2010
February 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Duration of Superior Hyolaryngeal Movement
Change in duration of superior elevation of hyoid bone.
baseline and six weeks
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 Outcomes (2)
Change in Oral Intake Ability
Baseline and 6 weeks
Change in Duration of Opening of Upper Esophageal Sphincter
Baseline and 6 weeks
Study Arms (1)
Within subjects treatment, no-treatment
EXPERIMENTALWithin 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).
Interventions
Mendelsohn Maneuver with Surface Electromyography
Eligibility Criteria
You may qualify if:
- Stroke (1-18 months post)
- Pharyngeal Dysphagia
You may not qualify if:
- Other neurologic or structural abnormality to oropharynx
- History of dysphagia prior to latest stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UArkansas/UAMS Medical Center
Little Rock, Arkansas, 72035, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary McCullough
- Organization
- UAMS Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Gary H McCullough, Ph.D.
University of Arkansas
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2007
First Posted
January 14, 2008
Study Start
July 1, 2003
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
March 20, 2018
Results First Posted
July 20, 2010
Record last verified: 2018-02