Cross-cultural Adaptation, Validation and Reliability of Turkish Version of Child Engagement in Daily Life Measure V2 for Children With Cerebral Palsy.
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.

      Research design:

      A cross-sectional and a single-centre study with a test-retest method and comparison group
      (children without disability) was conducted to determine the reliability and validity of the
      Turkish version of the CEDL V2.

      Participants:

      The study protocol was approved by the Medical Faculty of Yıldırım Beyazıd University Ethics
      Committee (26379996/28). Based on the principles stated in the Declaration of Helsinki, all
      subjects were informed about the study and the inform consent was taken from the families.

      Parents of children with CP 1.5-11 years of age who applied to the Physical Medicine and
      Rehabilitation Clinic of Ankara City Hospital will be included in the study. Parents of
      children with and without CP will be asked to complete the Turkish version of the CEDL V2 if
      they met the including criteria. Before completing the questionnaires, the sociodemographic
      characteristics of the parents of children with CP and without CP such as name, surname, age,
      gender, parent relationship to the child, parent's age, parent's education level, parent's
      work status, family income (monthly) will be recorded in medical records. Therapists will
      determine the child's GMFCS ve MACS level through observation and interview with the parent.
      The participants will be asked to participate in the test-retest component of the study and
      if they want they will complete the instrument after 2 weeks again. The parents of the
      children without CP will be asked to complete the measure independently of the primary study
      participants.

      Statistical Analysis The internal consistency of the CEDL scale will be determined by
      calculating Cronbach's alpha. Rasch analysis will be done by calculating the validity of the
      questionnaire (construct validity-known groups method) as in the original article. A sample
      size of 250 patients for Rasch analysis would be able to estimate item difficulty within the
      range of α=0.05 to ±0.32 logit. This sample size is also sufficient to test for item function
      difference. A difference of 0.32 between residuals with α=0.05 and β=0.20 Type I and II error
      values can be detected for any 2 groups .

      Latest status:

      The study was started on 01.10.2021 at Ankara Bilkent City Hospital , department of Physical
      Therapy and Rehabilitation in Turkey after approval for the present study had been obtained
      by the local ethics committee of the Yıldırım Beyazıt University and after the translation
      and cross-cultural adaptation of the measure had been completed . The measure was filled by
      parents of 273 children with cerebral palsy and 100 children without cerebral palsy.
    

Intervention name(s): Turkish version of Child Engagement in Daily Life Measure V2
Intervention type(s): Other
Intervention description(s): Child Engagement in Daily Life Measure V2 will be performed on both groups and GMFCS and MACS levels of children with cerebral palsy will be recorded.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Parents of children with cerebral palsy and children without cerebral palsy 1.5-11 years of
        age who applied to the Physical Medicine and Rehabilitation Clinic of Ankara Bilkent City
        Hospital will be included in the study.
      
Keywords: cerebral palsy; participation; self-care; measurement; validity; reliability; cultural adaptation