Diaphragmatic Function in Stroke Patients.

NCT ID: NCT01637649

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-06-30

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.

Conditions

Paralytic Stroke; Cough

Study Design

• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Stroke patients with dysphagia

Stroke patients with confirmed evidence of aspiration and severe dysphagia tha would require modified diet or nasogastric tube feeding

No interventions assigned to this group

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

No interventions assigned to this group

healthy volunteer group

healthy volunteers with no prior history of dysphagia or stroke and who are not included in the exclusion criteria

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Sun Im

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sun Im, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of medicine

Locations

Bucheon St Mary's Hospital, Catholic University of Korea

Bucheon-si, Gyenoggido, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 25234476 (View on PubMed)

Other Identifiers

5-2-0120-60-668

Identifier Type: -

Identifier Source: org_study_id