The Effectiveness of Oral Health in Improving Dysphagia o... | NCT03219346

Studies
The Effectiveness of Oral Health in Improving Dysphagia of Patients After Stroke of Swallowing Function and Oral Health Quality of Life

NCT03219346

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

Jul 18, 2018Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Swallowing Disorders
Stroke

Interventions

oral care program

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Feb 10, 2019Estimated

Completion Date

Feb 17, 2019Estimated

First Submitted Date

Jul 11, 2017

First Submission Date that Met QC Criteria

Jul 13, 2017

First Posted Date

Jul 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2018

Last Update Posted Date

Jul 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hsiao-Jung Chen, Principal Investigator, Chang Gung Memorial HospitalPrincipal Investigator

Lead Sponsor

Chang Gung Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The prevalence of chewing dysphagia in the domestic rehabilitation department ward was about 53.61%.Nasal tube retention of about 31%, due to nasogastric tube feeding, often overlooked oral hygiene, easy to cause respiratory tract infection. At the same time, oral hygiene will also affect the effectiveness of swallowing treatment, is worthy of attention to health problems.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral hygiene	Experimental		Other: oral care program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral care program	Other	Oral care (sputum and special needs of people cleaning teeth) time for three days a week (with swallowing treatment time before), once a day, each about 10 minutes of oral care program.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional oral intake scale	Seven different grades,Normal for 7 points;Total score of 1-7	before the first swallowing treatment (one day before treatment)

Secondary Outcomes

Measure	Description	Time Frame
Functional oral intake scale	Seven different grades,Normal for 7 points;Total score of 1-7	two weeks after the swallowing treatment (14 days)
Functional oral intake scale	Seven different grades,Normal for 7 points;Total score of 1-7

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of first stroke with nasal tube retention
Language therapist providing swallowing treatment
Caregiver providing oral care to patients

Exclusion Criteria:

Oral cancer
head and neck cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hsiao-Jung Chen	Contact	+886-3-2118800		crchen51@gmail.com

Overall Officials

Name	Affiliation	Role
Tzu-Ting Hung	Chang Gung University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung University	Recruiting	Taipei		333	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D003680	Deglutition Disorders
D020521	Stroke

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided