- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03811353
The Turkish Mastication Observation and Evaluation (T-MOE) Instrument
March 19, 2019 updated by: SELEN SEREL ARSLAN, Hacettepe University
Reliability and Validity of the Turkish Mastication Observation and Evaluation (T-MOE) Instrument
The purpose of this study is to test the reliability and validity of the T-MOE among pediatric patients with chewing disorders.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to test the reliability and validity of the T-MOE among pediatric patients with chewing disorders.The internal consistency, test-retest reliability, and criterion validity of T-MOE will be investigated.
The internal consistency will be assessed using Cronbach's alpha.
Intraclass correlation coefficient (ICC) value with 95 % confidence intervals will be calculated for test-retest reliability.
The criterion validity of the scale will be determined by assessing the correlation between the T-MOE and Karaduman Chewing Performance Scale and Tongue Thrust Rating Scale.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06100
- Hacetttepe University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 12 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children with serebral palsy and healthy children
Description
Inclusion Criteria:
- Having chewing disorders aged between 18 months-12 years
- Being serebral palsy
- Being healthy children
Exclusion Criteria:
- No chewing disorders
- A child aged below 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children with cerebral palsy
Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale.
Tongue control will also be evaluated by Tongue Thrust Rating Scale.
|
Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale.
|
Healthy children
Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale.
Tongue control will also be evaluated by Tongue Thrust Rating Scale.
|
Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Turkish Mastication Observation and Evaluation (T-MOE) Instrument
Time Frame: 3 months
|
This instrument is used to evaluate chewing function in children.
The T-MOE includes 8 items, and could be scored between 1 to 4. Higher scores indicate better chewing function, lower scores indicate worse chewing function.
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Karaduman Chewing Performance Scale (KCPS)
Time Frame: 3 months
|
This scale is used to determine chewing performance level of children.
The KCPS has 5 steps including 0 to 4. 0 means 'Normal chewing function' and 4 means 'No biting and chewing'.
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3 months
|
Tongue Thrust Rating Scale (TTRS)
Time Frame: 3 months
|
This scale is used to determine tongue thrust severity of children.
The TTRS has 4 steps between 0 to 3. Step 0 means 'No tongue thrust.' and step 3 means 'Severe tongue thrust.
The tongue is positioned out of the mouth.'
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 19, 2019
Primary Completion (Actual)
March 19, 2019
Study Completion (Actual)
March 19, 2019
Study Registration Dates
First Submitted
January 18, 2019
First Submitted That Met QC Criteria
January 18, 2019
First Posted (Actual)
January 22, 2019
Study Record Updates
Last Update Posted (Actual)
March 21, 2019
Last Update Submitted That Met QC Criteria
March 19, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ArslanSerel2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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