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

Primary Purpose

Swallowing Disorders, Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
oral care program
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Swallowing Disorders focused on measuring stroke , swallowing function ,oral health quality of life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Oral cancer
  2. head and neck cancer

Sites / Locations

  • Chang Gung UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral hygiene

Arm Description

Outcomes

Primary Outcome Measures

Functional oral intake scale
Seven different grades,Normal for 7 points;Total score of 1-7

Secondary Outcome Measures

Functional oral intake scale
Seven different grades,Normal for 7 points;Total score of 1-7
Functional oral intake scale
Seven different grades,Normal for 7 points;Total score of 1-7

Full Information

First Posted
July 11, 2017
Last Updated
July 17, 2018
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03219346
Brief Title
The Effectiveness of Oral Health in Improving Dysphagia of Patients After Stroke of Swallowing Function and Oral Health Quality of Life
Official Title
The Effectiveness of Oral Health in Improving Dysphagia of Patients After Stroke of Swallowing Function and Oral Health Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
February 10, 2019 (Anticipated)
Study Completion Date
February 17, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Swallowing Disorders, Stroke
Keywords
stroke , swallowing function ,oral health quality of life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral hygiene
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
oral care program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional oral intake scale
Description
Seven different grades,Normal for 7 points;Total score of 1-7
Time Frame
before the first swallowing treatment (one day before treatment)
Secondary Outcome Measure Information:
Title
Functional oral intake scale
Description
Seven different grades,Normal for 7 points;Total score of 1-7
Time Frame
two weeks after the swallowing treatment (14 days)
Title
Functional oral intake scale
Description
Seven different grades,Normal for 7 points;Total score of 1-7
Time Frame
three weeks after the swallowing treatment (21 days)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiao-Jung Chen
Phone
+886-3-2118800
Email
crchen51@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzu-Ting Hung
Organizational Affiliation
Chang Gung University
Official's Role
Study Director
Facility Information:
Facility Name
Chang Gung University
City
Taipei
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiao-Jung Chen
Phone
+886-3-2118800
Email
crchen51@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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