CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
Vibrotactile stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01765673
NCT01765673N/ACompleted
CompareCT.gov

Passy-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke

James Madison University·observational·Posted Jan 10, 2013·Updated Nov 14, 2017

In Brief

An observational study evaluating Vibrotactile stimulation for Oropharyngeal Dysphagia. Completed, enrolled 13 participants across 1 site.

Detailed Summary

This is a device evaluation study to determine the optimal stimulation characteristics for using vibrotactile stimulation as a sensory triggering device for self retraining in patients with chronic moderate to severe dysphagia. Stimulation characteristics to be tested are frequency of vibration, pressure between the device and the skin, mode of vibration (pulsed or continuous).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsOropharyngeal Dysphagia
CountriesUnited States
CollaboratorsPassy Muir Inc.

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 10, 2013
Enrollment StartJan 1, 2013
Primary CompletionFeb 22, 2016
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 13.5 years ago

Interventions

Vibrotactile stimulationdevice

Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.