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OpenTrials
Completed

NCT Number: NCT01637649

Diaphragmatic Function in Stroke Patients.

* 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Diaphragm movement during coughing

    Time frame: 1 day

    Diaphragm movement during voluntary coughing will be recorded by musculoskeletal sonogrpahy

Secondary outcomes

  1. Maximal inspiratory and expiratory pressure

    Time frame: 1 day

    respiratory pressure meter would be used to measure inspiratory and expiratory strength

  2. Pulmonary Function test

    Time frame: 1 day

    FVC, FEV1, FEF 25-75%, FVC/FEV1 ( % ), Peak cough flow

  3. Motricity index

    Time frame: Baseline

  4. Canadian Neurological Stroke Scale

    Time frame: Baseline

  5. Diaphragm movement during inspiration

    Time frame: 1 day

    Diaphragm movement will be recorded after deep inspiration

  6. Diaphragm movement during expiration

    Time frame: 1 day

    Diaphragm movement during expiration will be recorded

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

Diaphragm Function Evaluation in Stroke Patients During Voluntary Cough Using Sonography

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2012
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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