NCT03116646

Brief Summary

The family has a primary prescription in the identification of the chewing disorder in children to plan appropriate rehabilitation program and implementation of the training. Therefore, it is very important to investigate the validity and reliability of classification systems that can be applied by parents. The purpose of this study is to determine the validity and reliability of the reliability and validity of family report chewing evaluation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

8 months

First QC Date

April 11, 2017

Last Update Submit

May 31, 2020

Conditions

Keywords

masticationcerebral palsyfamily

Outcome Measures

Primary Outcomes (1)

  • Chewing evaluation

    Each child is required to bite and chew a standardized biscuit for chewing evaluation. The chewing function of each child is scored with the Karaduman Chewing Performance Scale.

    1 month

Study Arms (1)

Chewing evaluation

EXPERIMENTAL

Children with chewing disorders will be recruited. Each child is required to bite and chew a standardized biscuit for chewing evaluation. The chewing function of each child is scored with the Karaduman Chewing Performance Scale by a physical therapist. Then, the chewing function of each child is also scored with the Karaduman Chewing Performance Scale-Family report by their families.

Diagnostic Test: Chewing evaluation

Interventions

Chewing evaluationDIAGNOSTIC_TEST

Children with chewing disorders will be recruited. Each child is required to bite and chew a standardized biscuit for chewing evaluation. The chewing function of each child is scored with the Karaduman Chewing Performance Scale by a physical therapist. Then, the chewing function of each child is also scored with the Karaduman Chewing Performance Scale-Family report by their families.

Chewing evaluation

Eligibility Criteria

Age18 Months - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children above the age of 18 months
  • Children with chewing disorders

You may not qualify if:

  • Children below the age of 18 months
  • Children without chewing disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacetttepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • SELEN SEREL ARSLAN, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 17, 2017

Study Start

March 15, 2019

Primary Completion

November 20, 2019

Study Completion

November 20, 2019

Last Updated

June 2, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations