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Treatment of Dysphagia Using the Mendelsohn Maneuver

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ClinicalTrials.gov Identifier: NCT00592761
Recruitment Status : Completed
First Posted : January 14, 2008
Results First Posted : July 20, 2010
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stroke
Dysphagia
Intervention Behavioral: Mendelsohn Maneuver
Enrollment 18

Recruitment Details Recruitment of participants occurred through The University of Arkansas for Medical Sciences Medical Center Speech Pathology Clinic and newspaper advertisements between February 2003 and February 2010.
Pre-assignment Details Participants were only assigned to a group after their initial evaluation and no exclusions were necessary. Participants were each assigned to receive 2 weeks of treatment and two weeks of no treatment. Assignments were randomized so half began with treatment and half began with no treatment.
Arm/Group Title No Treatment Then Treatment Treatment Then No Treatment
Hide Arm/Group Description Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever. Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
Period Title: First Intervention (2 Weeks)
Started 9 9
Completed 9 9
Not Completed 0 0
Period Title: Second Intervention (2 Weeks)
Started 9 9
Completed 9 9
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description This includes all participants. Half received treatment then no treatment and have received no treatment then treatment.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  38.9%
>=65 years
11
  61.1%
[1]
Measure Description: Participants were analyzed for age effects within analysis of variance.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
7
  38.9%
Male
11
  61.1%
[1]
Measure Description: Gender effects were analyzed within the analysis of variance.
1.Primary Outcome
Title Change in Duration of Superior Hyolaryngeal Movement
Hide Description Change in duration of superior elevation of hyoid bone.
Time Frame baseline and six weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title No Treatment Then Treatment Treatment Then No Treatment
Hide Arm/Group Description:
Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: seconds
.213  (.154) .233  (.184)
2.Primary Outcome
Title Change in Duration of Hyoid Maximum Anterior Excursion
Hide Description Change in the duration of maximum anterior movement of the hyoid bone during swallowing.
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Treatment Then Treatment Treatment Then No Treatment
Hide Arm/Group Description:
Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: seconds
.233  (.157) .247  (.161)
3.Secondary Outcome
Title Change in Oral Intake Ability
Hide Description 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.
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Treatment Then Treatment Treatment Then No Treatment
Hide Arm/Group Description:
Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.8  (.15) 2.3  (.11)
4.Secondary Outcome
Title Change in Duration of Opening of Upper Esophageal Sphincter
Hide Description Change in duration of pre- and post-treatment duration of UES opening.
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Treatment Then Treatment Treatment Then No Treatment
Hide Arm/Group Description:
Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: seconds
.584  (.159) .610  (.183)
Time Frame Subjects were followed for up to one year after study completion.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Treatment Then Treatment Treatment Then No Treatment
Hide Arm/Group Description Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever. Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
All-Cause Mortality
No Treatment Then Treatment Treatment Then No Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
No Treatment Then Treatment Treatment Then No Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
No Treatment Then Treatment Treatment Then No Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Gary McCullough
Organization: UAMS Medical Center
Phone: 501-852-7886
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00592761     History of Changes
Other Study ID Numbers: R03DC004942 ( U.S. NIH Grant/Contract )
R03DC004942 ( U.S. NIH Grant/Contract )
First Submitted: December 27, 2007
First Posted: January 14, 2008
Results First Submitted: January 25, 2010
Results First Posted: July 20, 2010
Last Update Posted: March 20, 2018