Swallowing DisordersNCT03219346
The Effectiveness of Oral Health in Improving Dysphagia of Patients After Stroke of Swallowing Function and Oral Health Quality of Life
A study testing oral care program in people with Swallowing Disorders and Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Swallowing Disorders, Stroke
- What is being tested?
- oral care program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2017to 17 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of first stroke with nasal tube retention
- Language therapist providing swallowing treatment
- Caregiver providing oral care to patients
Who cannot join
- Oral cancer
- head and neck cancer
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taipei, 333
Hsiao-Jung Chen, +886-3-2118800, crchen51@gmail.com
About this study
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.
- Conditions
- Swallowing Disorders, Stroke
- Being tested
- oral care program
- Keywords
- stroke , swallowing function ,oral health quality of life
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral hygiene | Experimental | Not described Receives: Other: oral care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional oral intake scale
Seven different grades,Normal for 7 points;Total score of 1-7
Measured: before the first swallowing treatment (one day before treatment)
Secondary outcomes (2)
Functional oral intake scale
Seven different grades,Normal for 7 points;Total score of 1-7
Measured: two weeks after the swallowing treatment (14 days)
Functional oral intake scale
Seven different grades,Normal for 7 points;Total score of 1-7
Measured: three weeks after the swallowing treatment (21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start1 Jul 2017
- Primary completion10 Feb 2019 (estimated)
- Study completion17 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisordersStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Jung Chen, Chang Gung Memorial Hospital
- Investigators
- Tzu-Ting Hung, Study director, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219346
- Sponsor's protocol ID
- 201700143B0
- Status last verified
- Jul 2018
- First submitted
- 11 Jul 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Oral Health in Improving Dysphagia of Patients After Stroke of Swallowing Function and Oral Health Quality of Life
- ClinicalTrials.gov ID
- NCT03219346
- Acronym / sponsor ID
- 201700143B0
- Conditions
- Swallowing Disorders, Stroke
- Keywords
- stroke , swallowing function ,oral health quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 10 Feb 2019 (estimated)
- Study completion
- 17 Feb 2019 (estimated)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral hygiene | Experimental | Other: oral care program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of first stroke with nasal tube retention
- Language therapist providing swallowing treatment
- Caregiver providing oral care to patients
Key exclusion criteria (2 listed)
- Oral cancer
- head and neck cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral care programOral 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. | Other | Oral hygiene |
Primary outcome
Functional oral intake scale
Time frame: before the first swallowing treatment (one day before treatment)
Seven different grades,Normal for 7 points;Total score of 1-7
2 secondary outcomes
Functional oral intake scale
Time frame: two weeks after the swallowing treatment (14 days)
Functional oral intake scale
Time frame: three weeks after the swallowing treatment (21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzu-Ting Hung study director
Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral care program in people with Swallowing Disorders and Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsiao-Jung Chen (+886-3-2118800, crchen51@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional oral intake scale (time frame: before the first swallowing treatment (one day before treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.