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临床试验/NCT05871736
NCT05871736已完成不适用

Cross-cultural Adaptation, Validation and Reliability of Turkish Version of Child Engagement in Daily Life Measure V2 for Children With Cerebral Palsy.

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 373 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
373
试验地点
1
主要终点
Child Engagement in Daily Life Measure V2

研究概览

简要总结

Participation in daily activities provides many opportunities for children to improve cognitive, physical and communication abilities. Children's participation in recreational and community activities and performance of self-care activities are considered key processes and outcomes for pediatric rehabilitation. Cerebral palsy (CP), which is one of the most common causes of disability in childhood, is more common in our country than in developed countries. Standardized functional assessment scales should be used to objectively measure participation in daily life activities in children with disability such as cerebral palsy.

The aim of this study is to cross-culturally adapt the the Child Engagement in Daily Life Measure V2 (CEDL) to Turkish language and culture and to examine the structural validity and reliability of the Child Engagement in Daily Life Measure V2 (CEDL) in Turkish children with cerebral palsy.

详细描述

Purpose:

The aim of this study is to cross-culturally adapt the the Child Engagement in Daily Life Measure V2 (CEDL) to Turkish language and culture and to examine the structural validity and reliability of the Child Engagement in Daily Life Measure V2 (CEDL) in Turkish children with cerebral palsy.

Methods:

Translation and cross-cultural adaptation:

In the present study, permission for the translation and validation process of the CEDL V2 was obtained from the CEDL team at Drexel University. Based on previous studies and guidelines forward and backward translation methods were used to perform the crosscultural adaptation. In Stage 1, two independent professionals translated the CEDL V2 from English to Turkish. After the translated versions were harmonized as a first version (Stage 2) with discussion and consensus of translators and second author, a different bilingual translator with English as her native language performed a backtranslation (Stage 3), who was unfamiliar with and blinded to the original version of the CEDL V2 and the back-translation was reviewed by the developers of the CEDL V2 (Stage 4). In Stage 5, an expert committee, including first and second author, reviewed the prefinal Turkish version of the CEDL V2. Lastly, the prefinal version of the questionnaire was piloted in parents of children with disabilities (n = 30) and without disabilities (n = 30) to determine the clarity of all items and their compatibility for Turkish parents (Stage 6). The Turkish version of the CEDL V2 was finalized as the parents recruited for the pilot study indicated that clarity and understandability of the items were acceptable.

研究设计

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

入排标准

年龄范围
18 Months 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Volunteering to participate in the study,
  • They are the parents or caregivers of children
  • Their child has a clinical diagnosis cerebral palsy or has no clinical diagnosis
  • Their child is 1.5-11 years old during the study
  • The person who answered the questionnaire has Turkish literacy

排除标准

  • History of orthopedic surgery in the last three months
  • Illiterate participants

结局指标

主要结局

Child Engagement in Daily Life Measure V2

时间窗: two weeks

Child engagement in daily life measure Version 2( CEDL V2 ) is a 29-item parent proxy-report questionnaire. The questionnaire consists of two domains: (1) Participation in Family and Recreational Activities (Family Rec, 11 items), and (2) Performance of Self-care Activities (Self-care, 18 items) and takes approximately 15 min to complete. Two dimensions of Family Rec are rated on a 5-point Likert scale: frequency of participation (5¼very often to 1¼never) and enjoyment of participation (5¼a great deal to 1¼not at all). , Performance of Self-care Activities are rated on a 5-point Likert scale. On the scale , higher scores mean a better outcome. For the test-retest reliability, a sub-sample of parents of children with cerebral palsy will complete the measure again two weeks later.

次要结局

  • Manual Ability Classification System(baseline)
  • Gross Motor Function Classification System(baseline)

研究者

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

Hayriye Şimşek

Doctor

Ankara City Hospital Bilkent

研究点 (1)

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