Clinical trial NCT01637649: Diaphragmatic Function in Stroke Patients.
Official title: Diaphragm Function Evaluation in Stroke Patients During Voluntary Cough Using Sonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paralytic Stroke
Cough
Keywords: dysphagia,diaphragm, ultrasonography, inspiration, expiration,
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients from a university affiliated medical center

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diaphragm movement during coughing
timeFrame: 1 day
Secondary outcomes:
measure: Maximal inspiratory and expiratory pressure
timeFrame: 1 day
measure: Pulmonary Function test
timeFrame: 1 day
measure: Motricity index
timeFrame: Baseline
measure: Canadian Neurological Stroke Scale
timeFrame: Baseline
measure: Diaphragm movement during inspiration
timeFrame: 1 day
measure: Diaphragm movement during expiration
timeFrame: 1 day
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon St Mary's Hospital, Catholic University of Korea
state: Gyenoggido
Study officials:
affiliation: Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of medicine
name: Sun Im, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park GY, Kim SR, Kim YW, Jo KW, Lee EJ, Kim YM, Im S. Decreased diaphragm excursion in stroke patients with dysphagia as assessed by M-mode sonography. Arch Phys Med Rehabil. 2015 Jan;96(1):114-21. doi: 10.1016/j.apmr.2014.08.019. Epub 2014 Sep 16.