Diaphragmatic Function in Stroke Patients.

NCT01637649 | Completed DMC

• 1 other identifier: 5-2-0120-60-668
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Paralytic Stroke; Cough

Keywords

dysphagia,diaphragm, ultrasonography, inspiration, expiration,

Outcome Measures

Primary Outcomes (1)

• Diaphragm movement during coughing

  Diaphragm movement during voluntary coughing will be recorded by musculoskeletal sonogrpahy

  1 day

Secondary Outcomes (6)

• Maximal inspiratory and expiratory pressure

  1 day

• Pulmonary Function test

  1 day

• Motricity index

  Baseline

• Canadian Neurological Stroke Scale

  Baseline

• Diaphragm movement during inspiration

  1 day

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke patients from a university affiliated medical center

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

Bucheon St Mary's Hospital, Catholic University of Korea

Bucheon-si, Gyenoggido, 420-717, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25234476 DERIVED

MeSH Terms

Conditions

Stroke; Cough; Deglutition Disorders; Respiratory Aspiration; Death

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pathologic Processes

Study Officials

• Sun Im, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 7, 2012
• First Posted: July 11, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

KR (1)