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临床试验/NCT06944171
NCT06944171招募中不适用

Investigation of the Effects of Associated Impairments in School-Age Children With Cerebral Palsy on the Child's Activity and Participation Level and on Their Families

Hacettepe University1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
107
试验地点
1
主要终点
PEDI-CAT (Pediatric Evaluation of Disability Inventory Computer Adaptive Test)

研究概览

简要总结

This study will investigate the effects of associated impairments on the activity levels and social participation of school-aged children with Cerebral Palsy (aged 6-12) and their impact on their families' quality of life and caregiving burden.

详细描述

Cerebral Palsy (CP) defines a group of permanent disorders in movement and posture development, which are expressed as non-progressive disorders that occur in the developing baby brain during life in the womb or the first 3 years after birth, causing restrictions in activity and participation.

Hearing, speech, vision, cognitive, eating and swallowing problems and epilepsy primarily accompany the motor and postural control problems seen in CP. It is reported that cognitive disabilities or learning difficulties are seen in 50-75%, speech problems in 25%, hearing problems in 25%, seizures in 25-35% and visual disorders in 40-50% of individuals with CP. These primary problems, which accompany from the beginning, vary according to the clinical type and functional effect of CP and affect the severity of the existing CP clinical picture.

The International Classification of Functioning, Disability and Health (ICF) is a framework that guides the comprehensive assessment and treatment of children with CP by considering the wide range of health-related problems they face. The ICF includes four interrelated components: body structure and functions, activity and participation, and personal and environmental factors. According to the ICF, impairments are defined as significant deviations or losses in body structure and functions, while activity limitations, difficulties in activities, and participation restrictions are defined as problems in the form or scope of participation in life.

With these impairments added to the clinical picture, children with CP face significant limitations in their activity and participation levels. Therefore, it is important to define the relationship between comorbid impairments and activity and participation limitations in order to create holistic treatment goals and interventions that improve the activity and participation levels of children with CP.

According to the World Health Organization, quality of life, especially the health-related quality of life of parents of children with special needs, is a complex and comprehensive concept related to the physical health status, psychological status, independence level, social relationships, personal beliefs and environmental characteristics of the parents.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

PEDI-CAT (Pediatric Evaluation of Disability Inventory Computer Adaptive Test)

时间窗: Single assessment conducted during the initial study visit

The PEDI-CAT measures abilities in three functional domains: Daily Activities, Mobility and Social/Cognitive. The PEDI-CAT's Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex, multi-step life tasks.

LIFE-H 3.0 (The Assessment of life habits)

时间窗: Single assessment conducted during the initial study visit

The Assessment of life habits (LIFE-H) is a questionnaire that is used to collect information on all life habits that people carry out in their environment (home, workplace or school, neighborhood) to ensure their survival and development in society throughout their lifetime. LIFE-H uses a numerical scoring system ranging from 0 to 9. A score of 0 indicates a complete disability or impairment in participation, while a score of 9 indicates an optimal level of participation.

次要结局

  • Nottingham Health Profile(Single assessment conducted during the initial study visit)
  • Impact on Family Scale (IPFAM)(Single assessment conducted during the initial study visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Erdinler

Graduate Student

Hacettepe University

研究点 (1)

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