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

July 7, 2012
June 17, 2013
June 2012
June 2013   (final data collection date for primary outcome measure)
Diaphragm movement during coughing [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Diaphragm movement during voluntary coughing will be recorded by musculoskeletal sonogrpahy
Same as current
Complete list of historical versions of study NCT01637649 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Stroke patients from a university affiliated medical center

  • Paralytic Stroke
  • Cough
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01637649
5-2-0120-60-668
Yes
Sun Im, The Catholic University of Korea
The Catholic University of Korea
Not Provided
Principal Investigator: Sun Im, MD, PhD Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of medicine
The Catholic University of Korea
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP