Diaphragmatic Function in Stroke Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun Im, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01637649
First received: July 7, 2012
Last updated: June 17, 2013
Last verified: June 2013
  Purpose
  • 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.

Condition
Paralytic Stroke
Cough

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Diaphragm Function Evaluation in Stroke Patients During Voluntary Cough Using Sonography

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Diaphragm movement during coughing [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Diaphragm movement during voluntary coughing will be recorded by musculoskeletal sonogrpahy


Secondary Outcome Measures:
  • Maximal inspiratory and expiratory pressure [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    respiratory pressure meter would be used to measure inspiratory and expiratory strength

  • Pulmonary Function test [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    FVC, FEV1, FEF 25-75%, FVC/FEV1 ( % ), Peak cough flow

  • Motricity index [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Canadian Neurological Stroke Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Diaphragm movement during inspiration [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Diaphragm movement will be recorded after deep inspiration

  • Diaphragm movement during expiration [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Diaphragm movement during expiration will be recorded


Enrollment: 75
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Stroke patients from a university affiliated medical center

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637649

Locations
Korea, Republic of
Bucheon St Mary's Hospital, Catholic University of Korea
Bucheon, Gyenoggido, Korea, Republic of, 420-717
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Principal Investigator: Sun Im, MD, PhD Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of medicine
  More Information

No publications provided

Responsible Party: Sun Im, Assistant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01637649     History of Changes
Other Study ID Numbers: 5-2-0120-60-668
Study First Received: July 7, 2012
Last Updated: June 17, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
dysphagia,diaphragm, ultrasonography, inspiration, expiration,

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014