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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03811353
Other study ID # ArslanSerel2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 19, 2019
Est. completion date March 19, 2019

Study information

Verified date March 2019
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to test the reliability and validity of the T-MOE among pediatric patients with chewing disorders.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 19, 2019
Est. primary completion date March 19, 2019
Accepts healthy volunteers
Gender All
Age group 18 Months to 12 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
T-MOE
Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale.

Locations

Country Name City State
Turkey Hacetttepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Turkish Mastication Observation and Evaluation (T-MOE) Instrument 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. 3 months
Secondary The Karaduman Chewing Performance Scale (KCPS) 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'. 3 months
Secondary Tongue Thrust Rating Scale (TTRS) 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
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