Cerebral PalsyNCT05871736
Cross-cultural Adaptation, Validation and Reliability of Turkish Version of Child Engagement in Daily Life Measure V2 for Children With Cerebral Palsy.
An observational study of Cerebral Palsy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Turkish version of Child Engagement in Daily Life Measure V2
- How many people
- 373 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 11 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- History of orthopedic surgery in the last three months
- Illiterate participants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Üniversiteler Mahallesi 1604. Cadde No: 9 Çankaya/ANKARA, 06800
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Turkish version of Child Engagement in Daily Life Measure V2
- Keywords
- cerebral palsy, participation, self-care, measurement, validity, reliability, cultural adaptation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish version of Child Engagement in Daily Life Measure V2Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Turkish version of Child Engagement in Daily Life Measure V2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: two weeks
Secondary outcomes (2)
Gross Motor Function Classification System
The Gross Motor Function Classification System is a 5-level classification system that describes the gross motor function of children and youth with cerebral palsy on the basis of their self-initiated movement with particular emphasis on sitting, walking, and wheeled mobility. Distinctions between levels are based on functional abilities, the need for assistive technology, including hand-held mobility devices (walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement.
On the scale , the minimum value is 1 and maximum value 5 and the higher the level the poorer the functional ability of the child.
Measured: baseline
Manual Ability Classification System
The Manual Ability Classification System (MACS) describes how children with cerebral palsy use their hands to handle objects in daily activities. MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life.
On the scale , the minimum value is 1 and maximum value 5 and the higher the level the poorer the functional ability of the child.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Oct 2021
- Primary completion30 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayriye Şimşek, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871736
- Sponsor's protocol ID
- AnkaraCHBilkentHayriyesimsek01
- Status last verified
- Aug 2024
- First submitted
- 10 May 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36322490Chiarello 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.
PubMed 24467674Beaton 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.
PubMed 11124735Simsek 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 Jun;48(13):4242-4257. doi: 10.1080/09638288.2025.2603833. Epub 2026 Jan 1.
PubMed 41477705
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation, Validation and Reliability of Turkish Version of Child Engagement in Daily Life Measure V2 for Children With Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT05871736
- Acronym / sponsor ID
- AnkaraCHBilkentHayriyesimsek01
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, participation, self-care, measurement, validity, reliability, cultural adaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents of children with cerebral palsy | – | Other: Turkish version of Child Engagement in Daily Life Measure V2Parents of children with CP 1.5-11 years of age who applied to the Physical Medicine and Rehabilitation Clinic of Ankara City Hospital |
| Parents of children without cerebral palsy | – | Other: Turkish version of Child Engagement in Daily Life Measure V2Parents 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 |
Who may qualify
- Ages
- 18 months to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- History of orthopedic surgery in the last three months
- Illiterate participants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish version of Child Engagement in Daily Life Measure V2Child 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. | Other | Parents of children with cerebral palsy, Parents of children without cerebral palsy |
Primary outcome
Child Engagement in Daily Life Measure V2
Time frame: baseline
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
Child Engagement in Daily Life Measure V2
Time frame: 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.
2 secondary outcomes
Gross Motor Function Classification System
Time frame: baseline
Manual Ability Classification System
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 36322490Chiarello 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.
- Background: PubMed 24467674Chiarello 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.
- Background: PubMed 11124735Beaton 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.
- Derived from this study: PubMed 41477705Simsek 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 Jun;48(13):4242-4257. doi: 10.1080/09638288.2025.2603833. Epub 2026 Jan 1.
- The Child Engagement in Daily Life Measure (Version 2) and conversion tables, which provide an explanation and abbreviated information about the features of the updated version, are available at that linkLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Engagement in Daily Life Measure V2 (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05871736, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.