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Completed Phase 1Phase 2 Interventional Results available

Cough and Swallow Rehab Following Stroke

ClinicalTrials.gov ID: NCT01907321

Public ClinicalTrials.gov record NCT01907321. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 3:11 AM EDT

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Official title

Cough and Swallow Rehabilitation Following Stroke

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Stroke is the leading case of neurologic swallow dysfunction, or dysphagia. Post stroke dysphagia is associated with approximately 50% increase in the rate of pneumonia diagnoses; aspiration pneumonia is the most common respiratory complication in all stroke deaths, accounting for a three-fold increase in the 30-day post stroke death rate. The long-term goal of this systematic line of research is to decrease the morbidity, mortality, and health care costs associated with disordered airway protection following stroke. The overall hypothesis central to this proposal is that the ability to protect the airway is dependent upon a continuum of multiple behaviors, including swallowing and cough. Safe, efficient swallowing prevents material from entering the larynx and lower airway, and effective cough ejects aspirate or mucus material. Currently, only one end of the continuum, swallowing, is rigorously assessed in stroke patients. However, ineffective or disordered cough is indicative of the inability to eject aspirate material or clear mucus and secretions from the lower airway. Ineffective clearance and subsequent accumulation of material in the lower airway increases the risk of chest infection. Hence, patients at the greatest risk for chest infection would not only have disordered swallowing (dysphagia) but also disordered cough (dystussia), meaning they are more likely to aspirate material and then cannot effectively eject the aspirate from the airway. There is a high likelihood that swallowing and cough are simultaneously disordered following stroke. To date, there is a treatment that targets both swallowing and cough function in stroke patients. Expiratory muscle strength training (EMST) increases expiratory muscle strength (Baker et al., 2005) and there is evidence that supports its use to improve both swallow and cough functions in patients with Parkinson's disease (Troche et al., in press). This cross-system, device-driven approach to rehabilitating multiple contributors to airway protection deficits is highly desirable in the stroke population due to the likelihood of the co-occurrence of both swallow and cough disorders. To date, EMST has not been tested in stroke patients. We propose that by including cough in the screening, evaluation and treatment processes for disorders of airway protection, we will be able to better identify and treat patients most at risk for airway compromise and associated sequelae.

Study identification

NCT ID
NCT01907321
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
University of Florida
Other
Enrollment
14 participants

Conditions and interventions

Eligibility (public fields only)

Age range
50 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2010
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015
Last update posted
Jan 26, 2017

2011 – 2015

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
University of Florida Gainesville Florida 32611
Brooks Rehabilitation Clinical Research Center Jacksonville Florida 32216

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01907321, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 26, 2017 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01907321 live on ClinicalTrials.gov.

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