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Completed

NCT Number: NCT04134533

Comparison of Motor Functions and Quality of Life According to Feeding Type in Children With Cerebral Palsy

The aim of this study is to compare motor functions and quality of life of the children, and anxiety and depression levels of caregivers according to feeding type of children with cerebral palsy.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

About this study

The aim of this study is to compare motor functions and quality of life of the children, and anxiety and depression levels of caregivers according to feeding type of children with cerebral palsy. Children will be divided into two groups: children with oral feeding and children with non-oral feeding, according to Functional Oral Intake Scale. Gross Motor Function Classification System will be used for classify children according to gross motor function, Gross Motor Function Measurement will be used for evaluate gross motor functions, and parent-reported Pediatric Quality of Life Inventory will be used for evaluate quality of life of children. To measure caregivers' anxiety and depression levels will be assessed by using Beck Depression Inventory and Beck Anxiety Inventory. Parametric or non-parametric tests will be applied according to the variables distribution. Through this analyses, determination of the difference between feeding type groups and other categorical and continuous variables will be decided.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children who were diagnosed with CP
  • Aged between 5-18 years
  • Must have cooperation
  • Feed by orally or non-orally

Exclusion criteria

  • Having other accompanying neurodegenerative diseases.
  • Acute respiratory tract infection
  • Complications of enteral feeding

Treatment and study plan

Gross Motor Function Measurement

Other

These instruments will be used for determine the gross motor functional level and quality of life of the children with cerebral palsy and anxiety, depression levels of caregivers.

Other names: Pediatric Quality of Life Inventory, Beck Anxiety Inventory, Beck depression Inventory, Gross Motor Function Classification System

Primary outcomes

  1. Gross motor Function Measurement

    Time frame: 2 months

    The Gross Motor Function Measurement (GMFM) is an observational clinical tool to evaluate motor function of children with CP. It has five basic sections that evaluate motor function in detail, including lying and rolling; sitting; crawling and kneeling; standing; and walking, running, and jumping, with a total of 88 items. Each evaluation is scored according to the level of achieving gross motor function without considering the quality of movement. While children performing each task in the GMFM, a physiotherapist scored each evaluation on a Likert scale between 0 to 3, of which 0 means 'Does not initiate' and 3 means 'Completes'.

Secondary outcomes

  1. Gross Motor Function Classification System

    Time frame: 2 months

    The Gross Motor Function Classification System (GMFCS) was used to classify the level of gross motor functions in children with CP, and levels were based on child-initiated movement abilities, with emphasis on sitting, displacement, and mobility. The GMFCS uses a rating system of Level I to Level V, of which Level I shows the most independent functional motor level and Level V shows the most dependent functional motor level.

  2. Pediatric Quality of Life Inventory

    Time frame: 2 months

    Pediatric Quality of Life Inventory (PedsQL) was used to measure the parent-reported quality of life of children. The items of the PedsQL were scored between 0 to 100, of which 100 means "never", 75 means "almost never", 50 means "sometimes", 25 means "often", and 0 means "almost always". Points are collected and divided by the number of items filled to obtain the total score. Higher scores indicate better health-related quality of life.

  3. The Turkish version of the Beck Depression Inventory and Beck Anxiety Inventory

    Time frame: 2 months

    The Turkish version of the Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) were used to measure anxiety and depression levels of caregivers of children with CP. Both scales consist of 21 question and scored between 0-3. The highest score is 63.Higher scores indicate more severe anxiety or depression of an individual.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Motor Functional Level and Quality of Life According to Feeding Types in Children With Cerebral Palsy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2019
Registry last updated
Jan 18, 2020

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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