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Completed

NCT Number: NCT02984735

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).

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Key information

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacetttepe University

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation

Other

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.

Primary outcomes

  1. Chewing performance level

    Time frame: 10 minutes

    Chewing evaluation

Secondary outcomes

  1. Gross motor function level

    Time frame: 10 minutes

    Motor function evaluation

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 7, 2016
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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