Paralytic StrokeNCT01637649
Diaphragmatic Function in Stroke Patients.
An observational study of Paralytic Stroke and Cough, run by The Catholic University of Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Paralytic Stroke, Cough
- How many people
- 75 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke patients from a university affiliated medical center
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bucheon St Mary's Hospital, Catholic University of Korea
Bucheon-si, Gyenoggido, 420-717
About this study
Official title: 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.
Read the 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.
- Conditions
- Paralytic Stroke, Cough
- Keywords
- dysphagia,diaphragm, ultrasonography, inspiration, expiration,
- Medical subject headings
- Stroke, Cough, Deglutition Disorders, Respiratory Aspiration, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm movement during coughing
Diaphragm movement during voluntary coughing will be recorded by musculoskeletal sonogrpahy
Measured: 1 day
Secondary outcomes (6)
Maximal inspiratory and expiratory pressure
respiratory pressure meter would be used to measure inspiratory and expiratory strength
Measured: 1 day
Pulmonary Function test
FVC, FEV1, FEF 25-75%, FVC/FEV1 ( % ), Peak cough flow
Measured: 1 day
Motricity index
Measured: Baseline
Canadian Neurological Stroke Scale
Measured: Baseline
Diaphragm movement during inspiration
Diaphragm movement will be recorded after deep inspiration
Measured: 1 day
Diaphragm movement during expiration
Diaphragm movement during expiration will be recorded
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paralytic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Im, The Catholic University of Korea
- Investigators
- Sun Im, MD, PhD, Principal investigator, Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637649
- Sponsor's protocol ID
- 5-2-0120-60-668
- Status last verified
- Jun 2013
- First submitted
- 7 Jul 2012
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25234476
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Function Evaluation in Stroke Patients During Voluntary Cough Using Sonography
- ClinicalTrials.gov ID
- NCT01637649
- Acronym / sponsor ID
- 5-2-0120-60-668
- Conditions
- Paralytic Stroke, Cough
- Keywords
- dysphagia,diaphragm, ultrasonography, inspiration, expiration,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients from a university affiliated medical center
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diaphragm movement during coughing
Time frame: 1 day
Diaphragm movement during voluntary coughing will be recorded by musculoskeletal sonogrpahy
6 secondary outcomes
Maximal inspiratory and expiratory pressure
Time frame: 1 day
Pulmonary Function test
Time frame: 1 day
Motricity index
Time frame: Baseline
Canadian Neurological Stroke Scale
Time frame: Baseline
Diaphragm movement during inspiration
Time frame: 1 day
Diaphragm movement during expiration
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
- Derived from this study: PubMed 25234476Park 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Im, MD, PhD principal investigator
Department of Rehabilitation Medicine, Bucheon St Mary's Hospital, Catholic University of Korea, College of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paralytic Stroke and Cough, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm movement during coughing (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01637649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.