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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02984735
Other study ID # HACETTEPEUNI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2016
Est. completion date November 2016

Study information

Verified date January 2024
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 2 Years to 12 Years
Eligibility 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 Design


Intervention

Other:
Evaluation
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.

Locations

Country Name City State
Turkey Hacetttepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chewing performance level Chewing evaluation 10 minutes
Secondary Gross motor function level Motor function evaluation 10 minutes
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