NCT03219346

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2019

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.6 years

First QC Date

July 11, 2017

Last Update Submit

July 17, 2018

Conditions

Swallowing DisordersStroke

Keywords

stroke , swallowing function ,oral health quality of life

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Functional oral intake scale

    two weeks after the swallowing treatment (14 days)

  • Functional oral intake scale

    three weeks after the swallowing treatment (21 days)

Study Arms (1)

Oral hygiene

EXPERIMENTAL
Other: oral care program

Interventions

oral care programOTHER

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.

Oral hygiene

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Oral cancer
  • head and neck cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taipei, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Deglutition DisordersStroke

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Tzu-Ting Hung

    Chang Gung University

    STUDY DIRECTOR

Central Study Contacts

Hsiao-Jung Chen

CONTACT

+886-3-2118800crchen51@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 17, 2017

Study Start

July 1, 2017

Primary Completion

February 10, 2019

Study Completion

February 17, 2019

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

TW(1)