Investigating the Relation Between Environmental Factors and Activity-participation in Children With Cerebral Palsy

July 28, 2020 updated by: Özge ÇANKAYA, Hacettepe University
Cerebral palsy (CP) is a chronic condition that causes the most childhood disabilities on worldwide. Impairment in movement and posture development seen in children with CP it causes difficulties in performing activities and affect in emotional, social, and cognitive abilities cause limited participation in everyday life. The ICF-CY child is divided into five categories: body structure and functions, activities, participation, environmental and personal factors, it is treated holistically. Initially, children with CP have adopted the view that environmental factors can also affect functionality, while focusing on the treatment of motor disorders to reduce activity and participation limitations in physiotherapy and rehabilitation applications. Environmental factors; the environment in which the child lives, his family, the devices he uses, health and care services, and government policies. These factors vary according to each country's own cultural and economic opportunities. The investigator planned to do this study because we found that there is a need for a comprehensive study of children with SP in Turkey, which does not reveal the relationship between environmental factors and activity and level of participation.

Study Overview

Status

Completed

Conditions

Detailed Description

The study consist of two phases:

  1. European Child Environment Questionnaire (ECEQ) will translate in to Turkish in the first phase.

    • Forvard translation (translate to Turkish from English)
    • Expert opinion (Turkish version will control by expert)
    • Back translation (Turkish version will translate to English)
    • Cultural adaptation Validity and reliability study will done
  2. The relationship between environmental factors and activity and participation will be investigated in the second phase.

Eligibility Criteria

  • 2-18 years old
  • Cerebral palsy diagnosed
  • Children or family who understand and speek Turkish language
  • Children or family who know writing and reading
  • Volunteer to join the study

Outcome Measures

  1. Clinical classifications:

    Gross Motor Function Classification System (GMFCS) for classifying gross motor function levels Manuel ability classification system (MACS) for classifying fine motor function levels Communication Function Classification System (CFCS) for classifying communication function levels Eating Drinking Abilities Classsification System (EDACS) for classifying eating and drinking functions levels will be used

  2. Activity evaluation:

    Gross Motor Function Measurement (GMFM) Pediatric Evaluation of Disabilty Inventory (PEDI) will be used

  3. Participation:

    Life Habits Questionnaire (Life-H) will be used

  4. Environmental factors:

European Child Environment Questionnaire (ECEQ) Impact on Family Scale (IPFAM) will be used

Study Type

Observational

Enrollment (Actual)

306

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Özge Çankaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All types of cerebral palsy 20 children in each GMFCS levels

Description

Inclusion Criteria:

  • Diagnosed cerebral palsy
  • Volunteer to join the study
  • Know writing and reading
  • speeking Turkish

Exclusion Criteria:

  • Seconder neurologic impairment
  • not complete the evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
European Child Environment Questionnaire (ECEQ)
Time Frame: 20 minute
60 item, created for evaluating environmental factors. Higher values means environmental factors aren't for child. The ECEQ total score changes between 0-120. There is no subscale in ECEQ.
20 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: ÖZGE ÇANKAYA, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2018

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

August 26, 2019

Study Registration Dates

First Submitted

August 17, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Özge Çankaya

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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