The Passy Muir Swallowing Self Training Device (PMSST)
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ClinicalTrials.gov Identifier: NCT01765673 |
Recruitment Status
:
Completed
First Posted
: January 10, 2013
Results First Posted
: November 14, 2017
Last Update Posted
: November 14, 2017
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Condition or disease | Intervention/treatment |
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Oropharyngeal Dysphagia | Device: Vibrotactile stimulation |
Study Type : | Observational |
Actual Enrollment : | 13 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Passy-Muir Swallowing Self Training Device to Enhance Recovery Post Stroke |
Study Start Date : | January 1, 2013 |
Actual Primary Completion Date : | February 22, 2016 |
Actual Study Completion Date : | February 22, 2016 |

Group/Cohort | Intervention/treatment |
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Vibrotactile Stimulation in Dysphagia
A Vibrotactile stimulation device will be evaluated in patients with chronic moderate to severe dysphagia for more than 6 months post onset due to stroke or following radiation treatment for head and neck cancer to assess which frequency, mode, pressure characteristics are most helpful in increasing the rate of swallowing, increasing the urge to swallow, assisting with the initiation of swallowing and not affecting discomfort.
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Device: Vibrotactile stimulation
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.
Other Name: Passy Muir Swallowing Serlf Trainer
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- Change in Swallow Frequency 30 Hz [ Time Frame: During one session within 1 hour ]Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)
- Change in Swallow Frequency 70 Hz [ Time Frame: During one session within 1 hour ]Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)
- Change in Swallow Frequency 110 Hz [ Time Frame: During one session within 1 hour ]Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)
- Change in Swallow Frequency 150 Hz [ Time Frame: During one session within 1 hour ]Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)
- Change in Swallowing Frequency 70 & 110 Hz [ Time Frame: During one session within 1 hour ]Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)
- Change in Urge to Swallow After 30 Hz Stimulation [ Time Frame: During one session within 1 hour ]At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.
- Change in Urge to Swallow 70 Hz [ Time Frame: During one session within 1 hour ]At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.
- Change in VAS Urge to Swallow 110 Hz [ Time Frame: During one session within 1 hour ]At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.
- Change in VAS Urge to Swallow 150 Hz [ Time Frame: During one session within 1 hour ]At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.
- Change in VAS Urge to Swallow 70 & 110 Hz [ Time Frame: During one session within 1 hour ]At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.
- Change in Discomfort Level 30 Hz [ Time Frame: During one session within 1 hour ]At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.
- Change in Discomfort 70 Hz [ Time Frame: During one session within 1 hour ]At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.
- Change in Discomfort 110 Hz [ Time Frame: During one session within 1 hour ]At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.
- Change in Discomfort 150 Hz [ Time Frame: During one session within 1 hour ]At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.
- Change in Discomfort 70 & 110 Hz [ Time Frame: During one session within 1 hour ]At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.
- Change in Swallowing Frequency 2 kPa [ Time Frame: During one session within 1 hour ]The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between pressure between increased pressure and no pressure condition
- Change in Swallow Frequency 4 kPa [ Time Frame: During one session within 1 hour ]The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between pressure between increased pressure and no pressure condition
- Change in Swallow Frequency 6 kPa [ Time Frame: During one session within 1 hour ]The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between increased pressure and no pressure condition
- Percent Change in Swallow Frequency Pulse vs Continuous [ Time Frame: During one session within one hour ]Percent Change= [(Number of swallows per minute from continuous stimulation -number of swallows per minute during pulsed stimulation) / number of swallows per minute during pulsed stimulation] X 100
- Change in Swallow Initiation Time [ Time Frame: During one session within 1 hour ]Change in swallow initiation time (ms) from swallow reaction time during vibrotactile stimulation minus reaction time with sham (no) stimulation

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Stroke or post radiation for the treatment of head and neck cancer
- Dysphagia with a score of 2 or greater on the Penetration/Aspiration Scale OR a Mann Assessment of Swallowing Ability ordinal risk rating of "probable" or "definite"
Exclusion Criteria:
- Neck injury
- Epilepsy
- Neurological disorder other than stroke
- Psychiatric illness other than depression
- Uncontrolled gastroesophageal reflux disease
- Inability to communicate secondary to significant speech or language problems
- Inability to maintain alertness for 1 hour
- Significant health concerns that would put the participant at risk

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765673
United States, Virginia | |
James Madison University and Rockingham Memorial Hospital | |
Harrisonburg, Virginia, United States, 22801 |
Principal Investigator: | Christy L Ludlow, PhD | James Madison University |
Documents provided by Christy Ludlow, James Madison University:
Publications of Results:
Responsible Party: | Christy Ludlow, Professor, James Madison University |
ClinicalTrials.gov Identifier: | NCT01765673 History of Changes |
Other Study ID Numbers: |
R43DC012754 ( U.S. NIH Grant/Contract ) |
First Posted: | January 10, 2013 Key Record Dates |
Results First Posted: | November 14, 2017 |
Last Update Posted: | November 14, 2017 |
Last Verified: | September 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Christy Ludlow, James Madison University:
Swallowing Stroke Sensory stimulation Home based therapy Head and Neck Cancer |
Additional relevant MeSH terms:
Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases |