NCT02081040

Brief Summary

To record diaphragm excursion in infratentorial brain lesions patients with dysphagia during coughing and compare them to those with supratentorial brain lesion patients with dysphasia and those with no dysphagia at a university affiliated rehabilitation department.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

February 24, 2015

Status Verified

February 1, 2015

Enrollment Period

9 months

First QC Date

March 4, 2014

Last Update Submit

February 22, 2015

Conditions

Stroke

Keywords

brainstemdiaphragmdeglutition disordersonography

Outcome Measures

Primary Outcomes (1)

  • Diaphragm excursion

    Diaphragm excursion as assessed by m mode sonography

    baseline one time

Secondary Outcomes (2)

  • Maximal inspiratory pressure

    baseline one time

  • Peak cough flow force during voluntary coughing

    baseline one time

Other Outcomes (3)

  • maximal expiratory pressure

    baseline one time

  • spirometry findings

    baseline one time

  • Cough force during reflexive coughing

    baseline one time

Study Arms (3)

Infratentorial dysphagia patients

Infratentorial brain lesion patients with confirmed evidence of dysphagia

Supratentorial dysphagia patients

Supratentorial brain lesions\\ patients with confirmed evidence of dysphagia

Brain lesion patients without dysphagia

Brain lesion patients with no evidence of dysphagia

Other: Not applicable (observational study with no active intervention)

Interventions

Not applicable (observational study with no active intervention)OTHER
Brain lesion patients without dysphagia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Dysphagia patients due to brain lesions at a university affiliated hospital

You may qualify if:

  • Group 1- Brainstem lesion subjects with dysphagia that would require insertion of a nasogastric tube Group 2- Non-brainstem lesion subjects with dysphagia that would require insertion of a nasogastric tube Group 3- Stroke patients with no evidence of dysphagia

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
  • Patient with tracheostomy state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bucheon St Mary's Hospital

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

Location

MeSH Terms

Conditions

StrokeDeglutition Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Sun Im, MD PhD

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 7, 2014

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Study Completion

August 1, 2014

Last Updated

February 24, 2015

Record last verified: 2015-02

Locations

KR(1)