Diaphragmatic Function in Stroke Patients.

Cough Clinical Trial

Official title:

Diaphragm Function Evaluation in Stroke Patients During Voluntary Cough Using Sonography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637649
• Other study ID #: 5-2-0120-60-668
• Status: Completed
• Phase: N/A
• First received: July 7, 2012
• Last updated: June 17, 2013
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cough
• Paralytic Stroke
• Stroke

Locations

Country	Name	City	State
Korea, Republic of	Bucheon St Mary's Hospital, Catholic University of Korea	Bucheon	Gyenoggido

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragm movement during coughing	Diaphragm movement during voluntary coughing will be recorded by musculoskeletal sonogrpahy	1 day	No
Secondary	Maximal inspiratory and expiratory pressure	respiratory pressure meter would be used to measure inspiratory and expiratory strength	1 day	No
Secondary	Pulmonary Function test	FVC, FEV1, FEF 25-75%, FVC/FEV1 ( % ), Peak cough flow	1 day	No
Secondary	Motricity index		Baseline	No
Secondary	Canadian Neurological Stroke Scale		Baseline	No
Secondary	Diaphragm movement during inspiration	Diaphragm movement will be recorded after deep inspiration	1 day	No
Secondary	Diaphragm movement during expiration	Diaphragm movement during expiration will be recorded	1 day	No