NCT04134533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

October 25, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

October 17, 2019

Last Update Submit

January 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 Arms (2)

Oral Feeding Group

Children with cerebral palsy who fed orally according to the Functional Oral Intake Scale

Other: Gross Motor Function Measurement

Non-Oral Feeding Group

Children with cerebral palsy who fed non-orally according to the Functional Oral Intake Scale.

Other: Gross Motor Function Measurement

Interventions

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.

Also known as: Pediatric Quality of Life Inventory, Beck Anxiety Inventory, Beck depression Inventory, Gross Motor Function Classification System
Non-Oral Feeding GroupOral Feeding Group

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children with Cerebral Palsy

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 22, 2019

Study Start

October 25, 2019

Primary Completion

January 15, 2020

Study Completion

January 15, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations