NCT03640611

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
306

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

September 15, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2019

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

August 17, 2018

Last Update Submit

July 28, 2020

Conditions

Keywords

cerebral palsy, activity, participation, environmental factors, ICF-CY

Outcome Measures

Primary Outcomes (1)

  • European Child Environment Questionnaire (ECEQ)

    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

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All types of cerebral palsy 20 children in each GMFCS levels

You may qualify if:

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

You may not qualify if:

  • Seconder neurologic impairment
  • not complete the evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özge Çankaya

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Cankaya O, Kerem Gunel M, Ozdemir P. Construct-concurrent validity and reliability of the European Child Environment Questionnaire (ECEQ) in a sample of Turkish children with cerebral palsy. Disabil Rehabil. 2022 May;44(10):2104-2112. doi: 10.1080/09638288.2020.1822930. Epub 2020 Sep 29.

MeSH Terms

Conditions

Cerebral PalsyMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Officials

  • ÖZGE ÇANKAYA

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

August 17, 2018

First Posted

August 21, 2018

Study Start

September 15, 2018

Primary Completion

May 1, 2019

Study Completion

August 26, 2019

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations