Cerebral PalsyNCT03640611
Investigating the Relation Between Environmental Factors and Activity-participation in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Activity, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (CP) is a chronic condition that causes the most childhood disabilities on worldwide. Impairment in movement and posture development seen in children with CP it causes difficulties in performing activities and affect in emotional, social, and cognitive abilities cause limited participation in everyday… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cerebral Palsy, Activity, Participation
- How many people
- 306 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2018to 26 Aug 2019
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All types of cerebral palsy 20 children in each GMFCS levels
Who may be able to join
- Diagnosed cerebral palsy
- Volunteer to join the study
- Know writing and reading
- speeking Turkish
Who cannot join
- Seconder neurologic impairment
- not complete the evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Cerebral palsy (CP) is a chronic condition that causes the most childhood disabilities on worldwide. Impairment in movement and posture development seen in children with CP it causes difficulties in performing activities and affect in emotional, social, and cognitive abilities cause limited participation in everyday life. The ICF-CY child is divided into five categories: body structure and functions, activities, participation, environmental and personal factors, it is treated holistically. Initially, children with CP have adopted the view that environmental factors can also affect functionality, while focusing on the treatment of motor disorders to reduce activity and participation limitations in physiotherapy and rehabilitation applications. Environmental factors; the environment in which the child lives, his family, the devices he uses, health and care services, and government policies. These factors vary according to each country's own cultural and economic opportunities. The investigator planned to do this study because we found that there is a need for a comprehensive study of children with SP in Turkey, which does not reveal the relationship between environmental factors and activity and level of participation.
Read the detailed description
The study consist of two phases:
- European Child Environment Questionnaire (ECEQ) will translate in to Turkish in the first phase.
- Forvard translation (translate to Turkish from English)
- Expert opinion (Turkish version will control by expert)
- Back translation (Turkish version will translate to English)
- Cultural adaptation Validity and reliability study will done
- The relationship between environmental factors and activity and participation will be investigated in the second phase.
Eligibility Criteria
- 2-18 years old
- Cerebral palsy diagnosed
- Children or family who understand and speek Turkish language
- Children or family who know writing and reading
- Volunteer to join the study
Outcome Measures
- Clinical classifications: Gross Motor Function Classification System (GMFCS) for classifying gross motor function levels Manuel ability classification system (MACS) for classifying fine motor function levels Communication Function Classification System (CFCS) for classifying communication function levels Eating Drinking Abilities Classsification System (EDACS) for classifying eating and drinking functions levels will be used
- Activity evaluation: Gross Motor Function Measurement (GMFM) Pediatric Evaluation of Disabilty Inventory (PEDI) will be used
- Participation: Life Habits Questionnaire (Life-H) will be used
- Environmental factors:
European Child Environment Questionnaire (ECEQ) Impact on Family Scale (IPFAM) will be used
- Conditions
- Cerebral Palsy, Activity, Participation
- Keywords
- cerebral palsy, activity, participation, environmental factors, ICF-CY
- Medical subject headings
- Cerebral Palsy, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
European Child Environment Questionnaire (ECEQ)
60 item, created for evaluating environmental factors. Higher values means environmental factors aren't for child. The ECEQ total score changes between 0-120. There is no subscale in ECEQ.
Measured: 20 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start15 Sep 2018
- Primary completion1 May 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Hacettepe UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge ÇANKAYA, Hacettepe University
- Investigators
- ÖZGE ÇANKAYA, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640611
- Sponsor's protocol ID
- Özge Çankaya
- Status last verified
- Jul 2020
- First submitted
- 17 Aug 2018
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cankaya O, Kerem Gunel M, Ozdemir P. Construct-concurrent validity and reliability of the European Child Environment Questionnaire (ECEQ) in a sample of Turkish children with cerebral palsy. Disabil Rehabil. 2022 May;44(10):2104-2112. doi: 10.1080/09638288.2020.1822930. Epub 2020 Sep 29.
PubMed 32988240
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relation Between Environmental Factors and Activity-participation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03640611
- Acronym / sponsor ID
- Özge Çankaya
- Conditions
- Cerebral Palsy, Activity, Participation
- Keywords
- cerebral palsy, activity, participation, environmental factors, ICF-CY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 21 Aug 2018 (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.
Cerebral palsy (CP) is a chronic condition that causes the most childhood disabilities on worldwide. Impairment in movement and posture development seen in children with CP it causes difficulties in performing activities and affect in emotional, social, and cognitive abilities cause limited participation in everyday life. The ICF-CY child is divided into five categories: body structure and functions, activities, participation, environmental and personal factors, it is treated holistically. Initially, children with CP have adopted the view that environmental factors can also affect functionality, while focusing on the treatment of motor disorders to reduce activity and participation limitations in physiotherapy and rehabilitation applications. Environmental factors; the environment in which the child lives, his family, the devices he uses, health and care services, and government policies. These factors vary according to each country's own cultural and economic opportunities. The investigator planned to do this study because we found that there is a need for a comprehensive study of children with SP in Turkey, which does not reveal the relationship between environmental factors and activity and level of participation.
Detailed description
The study consist of two phases:
- European Child Environment Questionnaire (ECEQ) will translate in to Turkish in the first phase.
- Forvard translation (translate to Turkish from English)
- Expert opinion (Turkish version will control by expert)
- Back translation (Turkish version will translate to English)
- Cultural adaptation Validity and reliability study will done
- The relationship between environmental factors and activity and participation will be investigated in the second phase.
Eligibility Criteria
- 2-18 years old
- Cerebral palsy diagnosed
- Children or family who understand and speek Turkish language
- Children or family who know writing and reading
- Volunteer to join the study
Outcome Measures
- Clinical classifications: Gross Motor Function Classification System (GMFCS) for classifying gross motor function levels Manuel ability classification system (MACS) for classifying fine motor function levels Communication Function Classification System (CFCS) for classifying communication function levels Eating Drinking Abilities Classsification System (EDACS) for classifying eating and drinking functions levels will be used
- Activity evaluation: Gross Motor Function Measurement (GMFM) Pediatric Evaluation of Disabilty Inventory (PEDI) will be used
- Participation: Life Habits Questionnaire (Life-H) will be used
- Environmental factors:
European Child Environment Questionnaire (ECEQ) Impact on Family Scale (IPFAM) will be used
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All types of cerebral palsy 20 children in each GMFCS levels
Key inclusion criteria (4 listed)
- Diagnosed cerebral palsy
- Volunteer to join the study
- Know writing and reading
- speeking Turkish
Key exclusion criteria (2 listed)
- Seconder neurologic impairment
- not complete the evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
European Child Environment Questionnaire (ECEQ)
Time frame: 20 minute
60 item, created for evaluating environmental factors. Higher values means environmental factors aren't for child. The ECEQ total score changes between 0-120. There is no subscale in ECEQ.
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 29 Jul 2020.
- Derived from this study: PubMed 32988240Cankaya O, Kerem Gunel M, Ozdemir P. Construct-concurrent validity and reliability of the European Child Environment Questionnaire (ECEQ) in a sample of Turkish children with cerebral palsy. Disabil Rehabil. 2022 May;44(10):2104-2112. doi: 10.1080/09638288.2020.1822930. Epub 2020 Sep 29.
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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.
ÖZGE ÇANKAYA principal investigator
Hacettepe University
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 and Activity, run by Hacettepe University 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 4 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 29 Jul 2020. 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?
European Child Environment Questionnaire (ECEQ) (time frame: 20 minute). 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 NCT03640611, which also lists 1 linked publication.
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 29 Jul 2020.