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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
No Treatment Then Treatment Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
Treatment Then No Treatment Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.

Participant Flow for 2 periods

Period 1:   First Intervention (2 Weeks)
    No Treatment Then Treatment   Treatment Then No Treatment
STARTED   9   9 
COMPLETED   9   9 
NOT COMPLETED   0   0 

Period 2:   Second Intervention (2 Weeks)
    No Treatment Then Treatment   Treatment Then No Treatment
STARTED   9   9 
COMPLETED   9   9 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Entire Study Population This includes all participants. Half received treatment then no treatment and have received no treatment then treatment.

Baseline Measures
   Entire Study Population 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age [1] 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      7  38.9% 
>=65 years      11  61.1% 
[1] Participants were analyzed for age effects within analysis of variance.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Female      7  38.9% 
Male      11  61.1% 
[1] Gender effects were analyzed within the analysis of variance.


  Outcome Measures

1.  Primary:   Change in Duration of Superior Hyolaryngeal Movement   [ Time Frame: baseline and six weeks ]

2.  Primary:   Change in Duration of Hyoid Maximum Anterior Excursion   [ Time Frame: Baseline and 6 weeks ]

3.  Secondary:   Change in Oral Intake Ability   [ Time Frame: Baseline and 6 weeks ]

4.  Secondary:   Change in Duration of Opening of Upper Esophageal Sphincter   [ Time Frame: Baseline and 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: mcculloughgaryh@uams.edu



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