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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04134533
• Other study ID #: Feeding Types in CP
• Status: Completed
• Start date: October 25, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: January 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Gross Motor Function Measurement
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.

Locations

Country	Name	City	State
Turkey	Hacettepe 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	Gross motor Function Measurement	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'.	2 months
Secondary	Gross Motor Function Classification System	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 months
Secondary	Pediatric Quality of Life Inventory	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.	2 months
Secondary	The Turkish version of the Beck Depression Inventory and Beck Anxiety Inventory	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.	2 months