Chewing ProblemNCT03811353
The Turkish Mastication Observation and Evaluation (T-MOE) Instrument
An observational study of Chewing Problem and Swallowing Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to test the reliability and validity of the T-MOE among pediatric patients with chewing disorders. Read more about this study
- Who is it for?
- Ages 18 months to 12 years
- Conditions the study is for
- Chewing Problem, Swallowing Disorder
- What is being tested?
- T-MOE
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Feb 2019to 19 Mar 2019
- Phase
- Observational
- 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 18 months to 12 years
- All sexes
- Child
Study population: Children with serebral palsy and healthy children
Who may be able to join
- Having chewing disorders aged between 18 months-12 years
- Being serebral palsy
- Being healthy children
Who cannot join
- No chewing disorders
- A child aged below 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chewing Problem, Swallowing Disorder
- Being tested
- T-MOE
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-MOEDiagnostic test
Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: T-MOE | |
| 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. Receives: Diagnostic Test: T-MOE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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'.
Measured: 3 months
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.'
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start19 Feb 2019
- Primary completion19 Mar 2019
- Study completion19 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chewing ProblemStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SELEN SEREL ARSLAN, Hacettepe University
- Investigators
- SELEN SEREL ARSLAN, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811353
- Sponsor's protocol ID
- ArslanSerel2019
- Status last verified
- Mar 2019
- First submitted
- 18 Jan 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31292728
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Mastication Observation and Evaluation (T-MOE) Instrument
- ClinicalTrials.gov ID
- NCT03811353
- Acronym / sponsor ID
- ArslanSerel2019
- Conditions
- Chewing Problem, Swallowing Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 22 Jan 2019 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy | – | Diagnostic Test: T-MOEChewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale. Tongue control will also be evaluated by Tongue Thrust Rating Scale. |
| Healthy children | – | Diagnostic Test: T-MOEChewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale. Tongue control will also be evaluated by Tongue Thrust Rating Scale. |
Who may qualify
- Ages
- 18 months to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- Children with serebral palsy and healthy children
Key inclusion criteria (3 listed)
- Having chewing disorders aged between 18 months-12 years
- Being serebral palsy
- Being healthy children
Key exclusion criteria (2 listed)
- No chewing disorders
- A child aged below 6 months
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 |
|---|---|---|
| T-MOEChewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale. | Diagnostic test | Children with cerebral palsy, Healthy children |
Primary outcome
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.
2 secondary outcomes
The Karaduman Chewing Performance Scale (KCPS)
Time frame: 3 months
Tongue Thrust Rating Scale (TTRS)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Derived from this study: PubMed 31292728Serel 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.
- Individual participant dataSharing planned: No
Related trials for Chewing Problem
Active, not recruiting
Cognitive Changes and Neural Correlates After Rehabilitation of Masticatory Function in Elderly -an Intervention Study
Chewing Problem, Cognitive Decline
Not yet recruitingObservational study
Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT).
Mastication Disorder, Fatigue
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.
SELEN SEREL ARSLAN principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chewing Problem and Swallowing Disorder, run by Hacettepe University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 21 Mar 2019. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Turkish Mastication Observation and Evaluation (T-MOE) Instrument (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03811353, which also lists 1 linked publication.
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 21 Mar 2019.