Effect of Pharyngeal Exerciser in Rehabilitation of Pharyngeal Phase of Swallowing in Patients With Dysphagia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this a clinical trial is to test the effect of a pharyngeal exerciser in rehabilitation of pharyngeal phase of swallowing in patients with dysphagia. The main question it aims to answer is: •Does application of pharyngeal exerciser improve swallowing as evidenced by need for prescribed intervention for dysphagia (maneuvers, exercises or dietary modification to prevent aspiration). Participants will: * Perform barium swallows in lateral view fluoroscopy * Over a six-week period, perform thrice daily sessions of swallowing with an external, laryngeal restriction device covering the larynx * Return for another fluoroscopic barium swallow study

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Patients with dysphagia characterized by persistent pharyngeal residue on fluoroscopic study undergoing rehabilitative intervention (e.g.: exercises, maneuvers or dietary modification) for improving swallowing and preventing aspiration

⁃ Healthy elderly adult (≥65 years of age).

Locations
United States
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Reza Shaker, MD
rshaker@mcw.edu
4149556840
Backup
Mark Kern
mkern@mcw.edu
414-805-3826
Time Frame
Start Date: 2015-06-09
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 160
Treatments
Experimental: Pharyngeal exerciser group
In this group, the device will be placed around the neck overlying the laryngeal cartilage. Patients are asked to follow exercise regimen: to perform 30 swallows at 15 seconds interval against minimal resistance of 20 mm Hg applied by pharyngeal exerciser over larynx during the first 2 weeks. This is repeated 3 times per day and the external resistance is increased every 2 weeks from 20 to 30 mm Hg and subsequently from 30 to 40 mm Hg in another 2 weeks.
Sham_comparator: Sham exerciser group
In this group, sham device will be placed around the neck overlying the laryngeal cartilage. No external pressure will be applied during exercise. These patients will be asked to follow the exercise regimen: to perform repetitive tongue protrusion for 5 times without any pressure. This will be repeated 3 times a day for 6 weeks.
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov