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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00592761
Other study ID # R03DC004942
Secondary ID R03DC004942
Status Completed
Phase Phase 1/Phase 2
First received December 27, 2007
Last updated February 21, 2018
Start date July 2003
Est. completion date September 2008

Study information

Verified date February 2018
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mendelsohn Maneuver
Mendelsohn Maneuver with Surface Electromyography

Locations

Country Name City State
United States UArkansas/UAMS Medical Center Little Rock Arkansas

Sponsors (2)

Lead Sponsor Collaborator
University of Arkansas National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Duration of Superior Hyolaryngeal Movement Change in duration of superior elevation of hyoid bone. baseline and six weeks
Primary 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 Change in Oral Intake Ability 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. Baseline and 6 weeks
Secondary Change in Duration of Opening of Upper Esophageal Sphincter Change in duration of pre- and post-treatment duration of UES opening. Baseline and 6 weeks
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