Diaphragmatic Function in Stroke Patients.

Diaphragm Function Evaluation in Stroke Patients During Voluntary Cough Using Sonography

• 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.

Study Overview

• Status: Completed
• Conditions: Cough; Paralytic Stroke

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
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyenoggido
    • Bucheon, Gyenoggido, Korea, Republic of, 420-717
      • Bucheon St Mary's Hospital, Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stroke patients from a university affiliated medical center

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragm movement during coughing	Diaphragm movement during voluntary coughing will be recorded by musculoskeletal sonogrpahy	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 7, 2012
• First Submitted That Met QC Criteria: July 10, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Estimate): June 19, 2013
• Last Update Submitted That Met QC Criteria: June 17, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: dysphagia,diaphragm, ultrasonography, inspiration, expiration,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Stroke; Cough
• Other Study ID Numbers: 5-2-0120-60-668