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Clinical Trials/NCT04134533
NCT04134533
Completed
N/A

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

Hacettepe University1 site in 1 country35 target enrollmentOctober 25, 2019
ConditionsCerebral Palsy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Hacettepe University
Enrollment
35
Locations
1
Primary Endpoint
Gross motor Function Measurement
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 25, 2019
End Date
January 15, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emre CENGIZ

Research Assistant

Hacettepe University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Gross Motor Function Classification System(2 months)
  • Pediatric Quality of Life Inventory(2 months)
  • The Turkish version of the Beck Depression Inventory and Beck Anxiety Inventory(2 months)

Study Sites (1)

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