Cough and Swallow Rehab Following Stroke
Cough and Swallow Rehabilitation Following Stroke
1 other identifier
interventional
14
1 country
2
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2011
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 11, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
January 27, 2017
CompletedJanuary 27, 2017
October 1, 2016
4.2 years
July 11, 2013
April 18, 2016
December 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Expiratory Pressure
This measure will indicate if there are strength gains in the respiratory muscle by measuring expiratory pressure generating ability.
Change in baseline to week 7
Secondary Outcomes (1)
Cough Expiratory Airflow
Change in baseline to 7 weeks
Study Arms (2)
Expiratory muscle strength training (EMST)
EXPERIMENTALParticipants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.
Placebo expiratory training
PLACEBO COMPARATORSame look and feel of EMST with no resistance. Same protocol - 5 repetitions of 5 sets, 5 days per week
Interventions
Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure. Once sufficient pressure is achieved (participant blowing out into the device) a valve is released, letting air flow through.
Device with the same look and feel as the active EMST, but which provides no resistance to airflow.
Capsaicin is a cough-inducing vapor that will be inhaled by participants to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, peak expiratory flow rate, and post-peak plateau phase will be made.
Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Also included is the measure of maximum expiratory pressure. Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.
Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA).
Eligibility Criteria
You may qualify if:
- Acute (0-14 days) and subacute (14 days - 6 months) ischemic stroke
- Neurologic status permits participation.
- Medical status permits participation.
You may not qualify if:
- Dysphagia secondary to something other than stroke.
- Refuses consent.
- Incapable of informed consent and has no representative.
- Multiple strokes and previous history of dysphagia secondary to stroke.
- Longer than 6 months post-stroke
- Known cardiac valve thrombosis
- Stroke etiology of dissection
- Unstable / evolving stroke lesion.
- History of cancer in the head or neck
- History of radiation to the head or neck
- History of degenerative disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- American Heart Associationcollaborator
Study Sites (2)
University of Florida
Gainesville, Florida, 32611, United States
Brooks Rehabilitation Clinical Research Center
Jacksonville, Florida, 32216, United States
Related Publications (1)
Hegland KW, Davenport PW, Brandimore AE, Singletary FF, Troche MS. Rehabilitation of Swallowing and Cough Functions Following Stroke: An Expiratory Muscle Strength Training Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1345-51. doi: 10.1016/j.apmr.2016.03.027. Epub 2016 Apr 26.
PMID: 27130637DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Karen Hegland, PI
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Karen W Hegland, PHD
University of Florida
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2013
First Posted
July 24, 2013
Study Start
January 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
January 27, 2017
Results First Posted
January 27, 2017
Record last verified: 2016-10