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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640611
• Other study ID #: Özge Çankaya
• Status: Completed
• Start date: September 15, 2018
• Est. completion date: August 26, 2019

Study information

• Verified date: July 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: August 26, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Activity
• Cerebral Palsy
• Paralysis
• Participation

Locations

Country	Name	City	State
Turkey	Özge Çankaya	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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