Chewing Performance Level and Gross Motor Function in Children With Cerebral Palsy

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT02984735
Collaborator
(none)
152
1
10
15.2

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation

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 Design

Study Type:
Observational
Actual Enrollment :
152 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Association Between Chewing Performance Level and Gross Motor Function in Children With Cerebral Palsy
Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Chewing performance level [10 minutes]

    Chewing evaluation

Secondary Outcome Measures

  1. Gross motor function level [10 minutes]

    Motor function evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacetttepe University Ankara Turkey 06100

Sponsors and Collaborators

  • Hacettepe University

Investigators

  • Principal Investigator: SELEN SEREL ARSLAN, PhD, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SELEN SEREL ARSLAN, Selen Serel Arslan, Hacettepe University
ClinicalTrials.gov Identifier:
NCT02984735
Other Study ID Numbers:
  • HACETTEPEUNI
First Posted:
Dec 7, 2016
Last Update Posted:
Aug 3, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by SELEN SEREL ARSLAN, Selen Serel Arslan, Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2017