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出境医 / 临床实验 / The Turkish Mastication Observation and Evaluation (T-MOE) Instrument
The Turkish Mastication Observation and Evaluation (T-MOE) Instrument
Study Description
Brief Summary:
The purpose of this study is to test the reliability and validity of the T-MOE among pediatric patients with chewing disorders.
| Condition or disease | Intervention/treatment |
|---|---|
| Chewing Problem Swallowing Disorder | Diagnostic Test: T-MOE |
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 Design
| Study Type : | Observational |
| Actual Enrollment : | 80 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Reliability and Validity of the Turkish Mastication Observation and Evaluation (T-MOE) Instrument |
| Actual Study Start Date : | February 19, 2019 |
| Actual Primary Completion Date : | March 19, 2019 |
| Actual Study Completion Date : | March 19, 2019 |
Arms 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.
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Diagnostic Test: T-MOE
Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale.
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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.
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Diagnostic Test: T-MOE
Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale.
|
Outcome Measures
Primary Outcome Measures :
- 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 Outcome Measures :
- 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'.
- 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.'
Eligibility Criteria
| Ages Eligible for Study: | 18 Months to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Probability Sample |
Study Population
Children with serebral palsy and healthy children
Criteria
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
Contacts and Locations
Locations
| Turkey | |
| Hacetttepe University | |
| Ankara, Turkey, 06100 | |
Sponsors and Collaborators
Hacettepe University
Investigators
| Principal Investigator: | SELEN SEREL ARSLAN | Hacettepe University |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | January 18, 2019 | ||||
| First Posted Date | January 22, 2019 | ||||
| Last Update Posted Date | March 21, 2019 | ||||
| Actual Study Start Date | February 19, 2019 | ||||
| Actual Primary Completion Date | March 19, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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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| Original Primary Outcome Measures |
The Turkish Mastication Observation and Evaluation (T-MOE) Instrument [ Time Frame: 3 months ] This instrument is used to evaluate chewing function in children.
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| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | The Turkish Mastication Observation and Evaluation (T-MOE) Instrument | ||||
| Official Title | Reliability and Validity of the Turkish Mastication Observation and Evaluation (T-MOE) Instrument | ||||
| Brief Summary | The purpose of this study is to test the reliability and validity of the T-MOE among pediatric patients with chewing disorders. | ||||
| 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 | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Children with serebral palsy and healthy children | ||||
| Condition |
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| Intervention | Diagnostic Test: T-MOE
Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale.
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| Study Groups/Cohorts |
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| Publications * | Serel Arslan S, Demir N, Karaduman AA. Turkish Version of the Mastication Observation and Evaluation (MOE) Instrument: A Reliability and Validity Study in Children. Dysphagia. 2020 Apr;35(2):328-333. doi: 10.1007/s00455-019-10035-8. Epub 2019 Jul 10. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
80 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Actual Study Completion Date | March 19, 2019 | ||||
| Actual Primary Completion Date | March 19, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Months to 12 Years (Child) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Turkey | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03811353 | ||||
| Other Study ID Numbers | ArslanSerel2019 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | SELEN SEREL ARSLAN, Hacettepe University | ||||
| Study Sponsor | Hacettepe University | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Hacettepe University | ||||
| Verification Date | March 2019 | ||||
