Diaphragmatic Function in Stroke Patients.

Completed

• Conditions: Paralytic Stroke; Cough

• Registration Number: NCT01637649
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-07
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diaphragm movement during coughing	1 day	Diaphragm movement during voluntary coughing will be recorded by musculoskeletal sonogrpahy

Secondary Outcome Measures

Name	Time	Method
Maximal inspiratory and expiratory pressure	1 day	respiratory pressure meter would be used to measure inspiratory and expiratory strength
Pulmonary Function test	1 day	FVC, FEV1, FEF 25-75%, FVC/FEV1 ( % ), Peak cough flow
Motricity index	Baseline
Canadian Neurological Stroke Scale	Baseline
Diaphragm movement during inspiration	1 day	Diaphragm movement will be recorded after deep inspiration
Diaphragm movement during expiration	1 day	Diaphragm movement during expiration will be recorded

Trial Locations

Locations (1)

Bucheon St Mary's Hospital, Catholic University of Korea; 🇰🇷 Bucheon, Gyenoggido, Korea, Republic of