Treatment of Dysphagia Using the Mendelsohn Maneuver

Completed

Phase 1/2 Results

Trial Description

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.

Detailed 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.

Conditions

Interventions

  • Mendelsohn Maneuver Behavioral
    Intervention Desc: Mendelsohn Maneuver with Surface Electromyography
    ARM 1: Kind: Experimental
    Label: 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).

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Duration of Superior Hyolaryngeal Movement baseline and six weeks No
Primary Change in Duration of Hyoid Maximum Anterior Excursion Baseline and 6 weeks No
Secondary Change in Oral Intake Ability Baseline and 6 weeks Yes
Secondary Change in Duration of Opening of Upper Esophageal Sphincter Baseline and 6 weeks No

Sponsors