NCT05871736

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
373

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

May 10, 2023

Last Update Submit

August 8, 2024

Conditions

Keywords

cerebral palsyparticipationself-caremeasurementvalidityreliabilitycultural adaptation

Outcome Measures

Primary Outcomes (2)

  • Child Engagement in Daily Life Measure V2

    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. parents of children with cerebral palsy and parents of children without cerebral palsy will complete the measure at the first data collection point

    baseline

  • Child Engagement in Daily Life Measure V2

    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.

    two weeks

Secondary Outcomes (2)

  • Gross Motor Function Classification System

    baseline

  • Manual Ability Classification System

    baseline

Study Arms (2)

Parents of children with cerebral palsy

Parents of children with CP 1.5-11 years of age who applied to the Physical Medicine and Rehabilitation Clinic of Ankara City Hospital

Other: Turkish version of Child Engagement in Daily Life Measure V2

Parents of children without cerebral palsy

Parents of healthy children without cerebral palsy 1.5-11 years of age who applied to the Physical Medicine and Rehabilitation Clinic of Ankara City Hospital

Other: Turkish version of Child Engagement in Daily Life Measure V2

Interventions

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.

Parents of children with cerebral palsyParents of children without cerebral palsy

Eligibility Criteria

Age18 Months - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Üniversiteler Mahallesi 1604. Cadde No: 9 Çankaya/ANKARA, 06800, Turkey (Türkiye)

Location

Related Publications (4)

  • Chiarello LA, Alghamdi MS, McCoy SW, Avery L, Palisano RJ. Child engagement in daily life measure V2: validation of psychometric properties for children with cerebral palsy. Disabil Rehabil. 2023 Nov;45(23):3912-3921. doi: 10.1080/09638288.2022.2140849. Epub 2022 Nov 2.

    PMID: 36322490BACKGROUND
  • Chiarello LA, Palisano RJ, McCoy SW, Bartlett DJ, Wood A, Chang HJ, Kang LJ, Avery L. Child Engagement in Daily Life: a measure of participation for young children with cerebral palsy. Disabil Rehabil. 2014;36(21):1804-16. doi: 10.3109/09638288.2014.882417. Epub 2014 Jan 28.

    PMID: 24467674BACKGROUND
  • Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

    PMID: 11124735BACKGROUND
  • Simsek Ozguner H, Alkan BM, Gokmen D, Aktas S. Cross-cultural adaptation, validation and reliability of the Turkish version of Child engagement in daily life measure V2 for children with cerebral palsy. Disabil Rehabil. 2026 Jan 1:1-16. doi: 10.1080/09638288.2025.2603833. Online ahead of print.

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 23, 2023

Study Start

October 1, 2021

Primary Completion

May 30, 2023

Study Completion

May 31, 2023

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations