Treatment of Dysphagia Using the Mendelsohn Maneuver
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Dysphagia Using the Mendelsohn Maneuver|
- Change in Duration of Superior Hyolaryngeal Movement [ Time Frame: baseline and six weeks ] [ Designated as safety issue: No ]Change in duration of superior elevation of hyoid bone.
- Change in Duration of Hyoid Maximum Anterior Excursion [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]Change in the duration of maximum anterior movement of the hyoid bone during swallowing.
- Change in Oral Intake Ability [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: Yes ]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.
- Change in Duration of Opening of Upper Esophageal Sphincter [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]Change in duration of pre- and post-treatment duration of UES opening.
|Study Start Date:||July 2003|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Experimental: Within subjects treatment, no-treatment
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).
Behavioral: Mendelsohn Maneuver
Mendelsohn Maneuver with Surface Electromyography
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592761
|United States, Arkansas|
|UArkansas/UAMS Medical Center|
|Little Rock, Arkansas, United States, 72035|
|Principal Investigator:||Gary H McCullough, Ph.D.||University of Arkansas|