Expired Study
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Little Rock, Arkansas 72035


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.


Study summary:

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.


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


Study is Available At:


Original ID:

R03DC004942


NCT ID:

NCT00592761


Secondary ID:

R03DC004942


Study Acronym:


Brief Title:

Treatment of Dysphagia Using the Mendelsohn Maneuver


Official Title:

Treatment of Dysphagia Using the Mendelsohn Maneuver


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

N/A


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Arkansas


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gary H McCullough, Ph.D.
Principal Investigator
University of Arkansas

Study Dates

Start Date:July 2003
Completion Date:September 2008
Completion Type:Actual
Primary Completion Date:September 2008
Primary Completion Type:Actual
Verification Date:February 2018
Last Changed Date:February 21, 2018
First Received Date:December 27, 2007
First Results Date:January 25, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in Duration of Opening of Upper Esophageal Sphincter
Time Frame:Baseline and 6 weeks
Safety Issues:False
Description:Change in duration of pre- and post-treatment duration of UES opening.
Outcome Type:Secondary Outcome
Measure:Change in Oral Intake Ability
Time Frame:Baseline and 6 weeks
Safety Issues:False
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 peri
Outcome Type:Primary Outcome
Measure:Change in Duration of Hyoid Maximum Anterior Excursion
Time Frame:Baseline and 6 weeks
Safety Issues:False
Description:Change in the duration of maximum anterior movement of the hyoid bone during swallowing.
Outcome Type:Primary Outcome
Measure:Change in Duration of Superior Hyolaryngeal Movement
Time Frame:baseline and six weeks
Safety Issues:False
Description:Change in duration of superior elevation of hyoid bone.

Study Interventions

Intervention Type:Behavioral
Name:Mendelsohn Maneuver
Description:Mendelsohn Maneuver with Surface Electromyography
Arm Name:Within subjects treatment, no-treatment

Study Arms

Study Arm Type:Experimental
Arm Name:Within subjects treatment, no-treatment
Description: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).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Arkansas
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Deafness and Other Communication Disorders (NIDCD)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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