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NCT01907321 · ClinicalTrials.gov registry record · Phase 1
Cough and Swallow Rehab Following Stroke
A Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01907321 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 14 participants.
The verdict
NCT01907321, a Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
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 co
Interventions
- BEHAVIORAL Expiratory muscle strength training
- BEHAVIORAL Placebo expiratory training
- DRUG Measures performed on all subjects
- BEHAVIORAL Pulmonary function test
- RADIATION Fluoroscopic swallow study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-01 |
| Est. Completion | 2015-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01907321
The ClinicalTrials.gov registry entry for NCT01907321 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Expiratory muscle strength training is the first listed.
NCT01907321 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01907321 about?
NCT01907321 is a clinical study titled "Cough and Swallow Rehab Following Stroke". 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 incre...
What is the current status of trial NCT01907321?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2011-01. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01907321?
The interventions under investigation include: Expiratory muscle strength training (BEHAVIORAL), Placebo expiratory training (BEHAVIORAL), Measures performed on all subjects (DRUG), Pulmonary function test (BEHAVIORAL), Fluoroscopic swallow study (RADIATION).
Who is sponsoring clinical trial NCT01907321?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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