- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03241160
Chewing Disorders, Gross Motor Function and Trunk Control in Cerebral Palsy
September 8, 2017 updated by: SELEN SEREL ARSLAN, Hacettepe University
The Severity of Chewing Disorders is Related to Gross Motor Function and Trunk Control in Cerebral Palsy
The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP).
Study Overview
Detailed Description
The study is planned to determine the relationship between chewing performance level and gross motor function, and trunk postural control in cerebral palsy (CP).
Chewing performance level will be determined by the chewing performance scale.
The Gross Motor Function Classification System (GMFCS) will be used to determine gross motor function levels.
Segmental Assessment of Trunk Control (SATCo) will be used to measure trunk control.
The correlations between chewing performance level and gross motor function, and trunk postural control will be assessed.
The Chi-square test will also be used to compare GMFCS levels and trunk control in children with and without chewing disorders.
Study Type
Observational
Enrollment (Actual)
119
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey, 06100
- Hacetttepe University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 12 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children with a diagnosis of spastic cerebral palsy
Description
Inclusion Criteria:
- Having a diagnosis of cerebral palsy
- Referring by a pediatric neurologist
- Aging between 2 to 12 years
Exclusion Criteria:
- Aging under the age of 24 months
- Using any medicine and/or oral appliances that could affect the chewing performance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children with cerebral palsy
Children with a diagnosis of spastic cerebral palsy aged between 2 to 12 years who will be referred by pediatric neurologists will be included.
Children under the age of 24 months, and used any medicine and/or oral appliances that could affect the chewing performance, will be excluded.
Chewing evaluation will be performed.
|
Chewing evaluation will be performed.
An experienced physical therapist who will take a scale training session will do the chewing evaluation according to the chewing performance scale.This scale classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chewing evaluation
Time Frame: 15 days
|
Chewing evaluation will be determined by a scale that classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.
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15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross motor function evaluation
Time Frame: 15 days
|
Gross motor function evaluation will be performed according to the Gross Motor Function Classification System.
|
15 days
|
|
Trunk control evaluation
Time Frame: 15 days
|
Segmental Assessment of Trunk Control (SATCo) will be performed.
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15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 5, 2017
Primary Completion (Actual)
September 8, 2017
Study Completion (Actual)
September 8, 2017
Study Registration Dates
First Submitted
August 2, 2017
First Submitted That Met QC Criteria
August 2, 2017
First Posted (Actual)
August 7, 2017
Study Record Updates
Last Update Posted (Actual)
September 11, 2017
Last Update Submitted That Met QC Criteria
September 8, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HACETTEPE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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