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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04556487
Other study ID # GO-2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date February 15, 2023

Study information

Verified date March 2023
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Environment which children live and grown is very important for the all development stages. In Turkey there is no measurement for home environment evaluation so our aim is to investigate the Psychometric Properties of the Turkish version of Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) in a sample of Turkısh children.


Description:

With the advances in technology and medical fields, the rate of cerebral palsy is increasing worldwide with the increase in the survival rate of preterm, low birth weight babies and neurodevelopmentally risky babies living in neonatal intensive care units. The International Classification of Health, Function and Disability - Child and Youth version (ICF-CY), developed by the World Health Organization, provides a common language to record problems involving functions and structures of the body, restrictions of activity and participation that occur in childhood and adolescence, and related environmental factors; and It was developed to use terminology and consists of four main components: "Body Functions", "Body Structures", "Activity and Participation", "Environmental Factors". According to ICF-CY, environmental factors that have an effect on activity and participation are changeable factors. Therefore, it is stated that environmental conditions should be changed, redesigned and the child-supportive environment should be increased in order to increase the level of activity and participation in children. Preschool children spend most of their time at home and playing games. Toys in the game environment, playmates, parental participation and attitude play a major role in the development of the child's motor and cognitive skills and social participation (6, 7). In recent years, the importance and positive effects of the enriched environment on the motor and cognitive development of babies have been emphasized in studies. Regular neuromotor evaluations and follow-up of risky babies are guiding in establishing an early intervention program. The "Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS)" scale, developed to evaluate the characteristics of the environment in which babies live, is a valid and reliable scale that is frequently used in the literature in many different areas such as hearing loss, motor developmental delay, sensory impairment, and typical development. is a scale (8-11). Translation has been done in many different languages so far. Turkish infants at risk on a scale to evaluate the home environment in Turkey within our existing information is not yet available. It is thought that the introduction of the AHEMD-IS scale into the Turkish language will give clinicians and academicians a different perspective in the evaluation of risky babies and children.


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date February 15, 2023
Est. primary completion date April 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Months to 18 Months
Eligibility Inclusion Criteria: - Volunteer parents who have; - 3-18 months child/children - All children as typically developing children, genetic disorders, metabolic disorders, neuromotor disorders etc. Exclusion Criteria: - Parents who refuse to participate in the study

Study Design


Intervention

Other:
evaluation
we will evaluate the home environment of the children asking by parents

Locations

Country Name City State
Turkey Cumhuriyet University Sivas

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

1. Eunson P. Aetiology and epidemiology of cerebral palsy. J Paediatr Child Health. 2012;22(9):361-6.

2. World Health Organization. (2007). International Classification of Functioning, Disability, and Health: Children & Youth Version: ICF-CY. World Health Organization.

Outcome

Type Measure Description Time frame Safety issue
Primary Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS) Psychometric properties will be investigated. AHEMD-IS have 41 items with 3 section as outside and inside environment, daily activities and toys. Questions are answered in three categories: dichotomous, 4-degree likert and explanation-based. Higher scores means good environmental enrichment. 6 months
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