NCT03811353

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

February 19, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

28 days

First QC Date

January 18, 2019

Last Update Submit

March 19, 2019

Conditions

Chewing ProblemSwallowing Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The Karaduman Chewing Performance Scale (KCPS)

    3 months

  • Tongue Thrust Rating Scale (TTRS)

    3 months

Study Arms (2)

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.

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.

Diagnostic Test: T-MOE

Interventions

T-MOEDIAGNOSTIC_TEST

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

Children with cerebral palsyHealthy children

Eligibility Criteria

Age18 Months - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with serebral palsy and healthy children

You may qualify if:

  • Having chewing disorders aged between 18 months-12 years
  • Being serebral palsy
  • Being healthy children

You may not qualify if:

  • No chewing disorders
  • A child aged below 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacetttepe University

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 31292728DERIVED

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • SELEN SEREL ARSLAN

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2019

First Posted

January 22, 2019

Study Start

February 19, 2019

Primary Completion

March 19, 2019

Study Completion

March 19, 2019

Last Updated

March 21, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)