- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984735
Chewing Performance Level and Gross Motor Function in Children With Cerebral Palsy
January 3, 2024 updated by: SELEN SEREL ARSLAN, Hacettepe University
Association Between Chewing Performance Level and Gross Motor Function in Children With Cerebral Palsy
The purpose of this study is to determine the association between gross motor function and chewing performance level in children with cerebral palsy (CP).
A cross-sectional study was conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP.
The Gross Motor Function Classification System (GMFCS) was used to determine gross motor function levels of children.
Chewing performance level was determined by using the Karaduman Chewing Performance Scale (KCPS).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The purpose of this study is to determine the association between gross motor function and chewing performance level in children with cerebral palsy (CP).
A cross-sectional study was conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP.
The Gross Motor Function Classification System (GMFCS) was used to determine gross motor function levels of children.
Chewing performance level was determined by using the Karaduman Chewing Performance Scale (KCPS).Children with a diagnosis of spastic CP aged 2 to 12 years who were referred due to chewing/swallowing problems by pediatric neurologists were included.
The inclusion criteria were above the age of 24 months, and had complaints about chewing function.
Children under the age of 24 months, requiring tube feeding or taking any oral nutritional supplements, and used any medicine and/or oral appliances that could affect the chewing performance, were excluded.
Study Type
Observational
Enrollment (Actual)
152
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
No
Sampling Method
Probability Sample
Study Population
Children with a diagnosis of spastic CP aged 2 to 12 years who were referred due to chewing/swallowing problems by pediatric neurologists
Description
Inclusion Criteria:
- Above the age of 24 months
- Having complaints about chewing function.
Exclusion Criteria:
- Under the age of 24 months
- Requiring tube feeding or taking any oral nutritional supplements
- Using any medicine and/or oral appliances
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 |
|---|---|
|
Evaluation of children with spastic CP
Children with a diagnosis of spastic CP aged 2 to 12 years who were referred due to chewing/swallowing problems by pediatric neurologists were included.
The inclusion criteria were above the age of 24 months, and had complaints about chewing function.
Children under the age of 24 months, requiring tube feeding or taking any oral nutritional supplements, and used any medicine and/or oral appliances that could affect the chewing performance, were excluded.
|
Descriptive characteristics including age, height and weight were recorded.
Chewing performance level was determined with the Karaduman Chewing Performance Scale (KCPS).
Each child was placed in a sitting position (either on a chair or on his/her mother's arm) with the head upright and with the midline position and arms and legs supported, and required to bite and chew a standardized biscuit, and no clue was given on how to chew.
The physical therapist rated the chewing performance according to the KCPS.
All children underwent a physical examination by a physical therapist to determine gross motor function by applying the Gross Motor Function Classification System (GMFCS).
In addition to GMFCS, number of affected limbs of the children was also noted.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chewing performance level
Time Frame: 10 minutes
|
Chewing evaluation
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10 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gross motor function level
Time Frame: 10 minutes
|
Motor function evaluation
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10 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: SELEN SEREL ARSLAN, PhD, Hacettepe University
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
January 1, 2016
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
December 3, 2016
First Submitted That Met QC Criteria
December 6, 2016
First Posted (Estimated)
December 7, 2016
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 3, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HACETTEPEUNI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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