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

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03219346
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 19.6
• Patients Per Site Per Month: 5.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Swallowing Disorders; Stroke	Other: oral care program	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Effectiveness of Oral Health in Improving Dysphagia of Patients After Stroke of Swallowing Function and Oral Health Quality of Life
• Actual Study Start Date: Jul 1, 2017
• Anticipated Primary Completion Date: Feb 10, 2019
• Anticipated Study Completion Date: Feb 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oral hygiene	Other: oral care program; 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.

Outcome Measures

Primary Outcome Measures

1. Functional oral intake scale [before the first swallowing treatment (one day before treatment)]

   Seven different grades,Normal for 7 points;Total score of 1-7

Secondary Outcome Measures

1. Functional oral intake scale [two weeks after the swallowing treatment (14 days)]

   Seven different grades,Normal for 7 points;Total score of 1-7

2. Functional oral intake scale [three weeks after the swallowing treatment (21 days)]

   Seven different grades,Normal for 7 points;Total score of 1-7

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung University	Taipei		Taiwan	333

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

• Study Director: Tzu-Ting Hung, Chang Gung University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hsiao-Jung Chen, Principal Investigator, Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT03219346
• Other Study ID Numbers: 201700143B0
• First Posted: Jul 17, 2017
• Last Update Posted: Jul 18, 2018
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hsiao-Jung Chen, Principal Investigator, Chang Gung Memorial Hospital: stroke , swallowing function ,oral health quality of life
• Additional relevant MeSH terms: Deglutition Disorders; Stroke

Study Results

No Results Posted as of Jul 18, 2018