Diaphragmatic Function in Stroke Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01637649
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : June 19, 2013
Information provided by (Responsible Party):
Sun Im, The Catholic University of Korea

Brief Summary:
  • This study attempts to elucidate whether stroke patients with dysphagia have reduced diaphragm movement during voluntary coughing, and also during deep inspiration and expiration than stroke patients without dysphagia.
  • This study will also compare various spirometric measurements with the diaphragmatic motions.

Condition or disease
Paralytic Stroke Cough

Detailed Description:

Stroke is a debilitating condition that can impair multiple functions, including swallowing. Stroke patients with dysphagia, are known to have reduced cough due to multiple mechanisms and this can impair their expectorate function. This can lead to accumulation of sputum and mucoid, ultimately resulting in aspiration pneumonia. Stroke patients, especially those with dysphagia, are also known to have expiratory muscle weakness and weak cough than healthy controls. Stroke patients are also known to have reduced diaphragm movement than healthy subjects. Sonography is a useful tool that can easily and reliability measure diaphragm movement. Whether stroke patients with dysphagia have reduced diaphragm movement than those without dysphagia and whether this affects voluntary cough have not been reported yet.

This study attempts to evaluate diaphragm movements during voluntary cough in stroke patients with dysphagia and determine whether this reduced diaphragm movement correlates to their peak flow meters during voluntary cough.

Study Type : Observational
Actual Enrollment : 75 participants
Time Perspective: Cross-Sectional
Official Title: Diaphragm Function Evaluation in Stroke Patients During Voluntary Cough Using Sonography
Study Start Date : June 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough
U.S. FDA Resources

Stroke patients with dysphagia
Stroke patients with confirmed evidence of aspiration and severe dysphagia tha would require modified diet or nasogastric tube feeding
Stroke patients without dysphagia
Stroke patients but with no gross evidence of dysphagia or with mild dysphagia with a Penetration aspiration scale of less than 4
healthy volunteer group
healthy volunteers with no prior history of dysphagia or stroke and who are not included in the exclusion criteria

Primary Outcome Measures :
  1. Diaphragm movement during coughing [ Time Frame: 1 day ]
    Diaphragm movement during voluntary coughing will be recorded by musculoskeletal sonogrpahy

Secondary Outcome Measures :
  1. Maximal inspiratory and expiratory pressure [ Time Frame: 1 day ]
    respiratory pressure meter would be used to measure inspiratory and expiratory strength

  2. Pulmonary Function test [ Time Frame: 1 day ]
    FVC, FEV1, FEF 25-75%, FVC/FEV1 ( % ), Peak cough flow

  3. Motricity index [ Time Frame: Baseline ]
  4. Canadian Neurological Stroke Scale [ Time Frame: Baseline ]
  5. Diaphragm movement during inspiration [ Time Frame: 1 day ]
    Diaphragm movement will be recorded after deep inspiration

  6. Diaphragm movement during expiration [ Time Frame: 1 day ]
    Diaphragm movement during expiration will be recorded

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Stroke patients from a university affiliated medical center

Inclusion Criteria:

  • Stroke patients with confirmed unilateral brain lesion
  • Gross aspiration confirmed via FEES or VFSS that would require non oral feeding for group 1.
  • No gross evidence of dysphagia that would require non oral feeding for group 2.
  • No prior episode of stroke or dysphagia for the healthy control group.

Exclusion Criteria:

  • Episode of acute pneumonia or pulmonary embolism at time of enrollment
  • Previous history of chronic respiratory disorders or other systemic disorders that may affect respiratory function ( ex, rheumatoid arthritis, chronic renal disease, spinal cord injury)
  • Stroke patients with multiple brain lesions
  • Episode of Diaphragm weakness due to peripheral polyneuropathy or unilateral phrenic nerve palsy
  • Previous episode of abdominal or thoracic surgery within one year of enrollment
  • Concomitant diagnosis of myopathy, muscular dystrophy or other disorders that may affect respiratory muscles.
  • Episode of rib fracture within one year of enrollment
  • Chronic alcoholism
  • Patient with previous diagnosis of dementia or with impaired cognitive function that may limit full participation at the evaluation.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01637649

Korea, Republic of
Bucheon St Mary's Hospital, Catholic University of Korea
Bucheon, Gyenoggido, Korea, Republic of, 420-717
Sponsors and Collaborators
The Catholic University of Korea
Principal Investigator: Sun Im, MD, PhD Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sun Im, Assistant Professor, The Catholic University of Korea Identifier: NCT01637649     History of Changes
Other Study ID Numbers: 5-2-0120-60-668
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Sun Im, The Catholic University of Korea:
dysphagia,diaphragm, ultrasonography, inspiration, expiration,

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms