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Completed

NCT Number: NCT03811353

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.

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Key information

Conditions

Chewing Problem Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Swallowing Disorder

Age range

18 month–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacetttepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-MOE

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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'.

  2. 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.'

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Reliability and Validity of the Turkish Mastication Observation and Evaluation (T-MOE) Instrument

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 22, 2019
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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