Cerebral PalsyNCT05313698
Validity and Reliability of The Turkish Version of The Kidscreen-27
An observational study of Cerebral Palsy, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
Functional impairment of the upper extremities can impair the health-related quality of life (HRQOL) of persons with Cerebral Palsy CP. Health-related quality of life (HRQOL) measures several subjective dimensions dealing with the impact of health or illness on physical and psychosocial functioning. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 May 2022
- 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 8 to 18 years
- All sexes
- Child, Adult
Study population: Children with all typologies of cerebral palsy and their parents/caregivers
Who may be able to join
- Children with cerebral palsy who have sufficient intellectual level to answer KIDSCREEN-27' items
Who cannot join
- children with severe intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability of The Turkish Version of The Kidscreen-27 Questionnaires in Individuals With Cerebral Palsy
Functional impairment of the upper extremities can impair the health-related quality of life (HRQOL) of persons with Cerebral Palsy CP. Health-related quality of life (HRQOL) measures several subjective dimensions dealing with the impact of health or illness on physical and psychosocial functioning. Quality of life (QOL) measures for children and adolescents have been developed in recent years, initially for children with specific chronic conditions, but more recently generic and health-related QOL (HRQOL) measures have been developed . The early assessments of children's quality of life were mostly disease-specific, and this trend has continued. Generic HRQOL measurements for children and adolescents can help identify subgroups of children and adolescents who are at risk of developing health problems. KIDSCREEN-27 is a generic HRQOL measure derived from KIDSCREEN-52. The KIDSCREEN-27 is a subset of the KIDSCREEN-52 that includes 27 items for assessing HRQOL across five dimensions: Physical Well-Being (5 items) examines a child's or adolescent's level of physical activity, energy, and fitness. Although the psychometric properties of the Turkish version of the KIDSCREEN forms have been studied previously; however, its psychometric characteristics in children with CP have yet to be determined. Accordingly, the aim of this study is to provide an overview of the psychometric results of the KIDSCREEN-27 HRQOL questionnaire
Read the detailed description
Children with CP generally report a lower QOL than their normally developing peers. Quality of life (QOL) is now recognized as an important outcome of interventions because it relates to a person's individual cognition or well-being in a range of domains (e.g., physical, social, emotional, spiritual). Health-related quality of life (HRQOL) is a subdomain of the more global construct of QOL, including domains such as physical, mental, and social well-being Recently, there has been a surge in interest in assessing the quality of life (QOL) of children with cerebral palsy (CP). QOL instruments are increasingly used to assess the effectiveness of interventions for children with CP. To assess QOL, there are both generic and condition-specific scales available. The Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child), the Child Health Questionnaire (CHQ), European generic health related quality of life questionnaire (KIDSCREEN), and the Pediatric Quality of Life Inventory are some of the most used instruments. Out of these QOL instruments, European generic health related quality of life questionnaire (KIDSCREEN) is a generic QOL questionnaire and KIDSCREEN-27 is a shorter version of the KIDSCREEN-52 questionnaire to evaluate HRQOL outcomes of children and adolescents between the ages of 8-18 years. . Generic scales are useful for comparing groups since they are designed to be relevant to all subgroups of the population. Because they do not include domains that are relevant to the sickness or disability, they are less useful for evaluating the effectiveness of an intervention for children with that illness or disability. Condition-specific scales are useful for detecting changes in QOL for a given condition and are designed to be applicable to a group. Instruments that are condition-specific can capture the domains of QOL that are significant to children and adolescents with CP. Although the psychometric properties of KIDSCREEN-27 tests have been extensively studied in healthy children and adolescents, there has been no research to date on the psychometric features of KIDSCREEN-27 instruments in cerebral palsy children and adolescents. Thus, the aims of this study were to examine and determine the construct-concurrent validity and reliability of the Turkish version of the self and proxy versions of KIDSCREEN-27 questionnaire in individuals with cerebral palsy
- Conditions
- Cerebral Palsy
- Being tested
- No intervention
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDiagnostic test
cross-sectional study/psychometric study
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency from baseline in mean scores of KIDSCREEN-27 at week 2
The KIDSCREEN-27 is a 27-item variation of the KIDSCREEN-52 questionnaire that includes five dimensions of health-related quality of life (HRQOL). It is a valid and reliable tool for assessing children's and adolescents' HRQOL outcomes
Measured: Change from Baseline KIDCREEN-27 mean scores at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Jan 2022
- Primary completion1 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Bingöl, Muş Alparslan University
- Investigators
- Mintaze KEREM GUNLE, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313698
- Sponsor's protocol ID
- 16969557-2167
- Status last verified
- May 2022
- First submitted
- 22 Mar 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of The Turkish Version of The Kidscreen-27 Questionnaires in Individuals With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05313698
- Acronym / sponsor ID
- 16969557-2167
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 6 Apr 2022 (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.
Functional impairment of the upper extremities can impair the health-related quality of life (HRQOL) of persons with Cerebral Palsy CP. Health-related quality of life (HRQOL) measures several subjective dimensions dealing with the impact of health or illness on physical and psychosocial functioning. Quality of life (QOL) measures for children and adolescents have been developed in recent years, initially for children with specific chronic conditions, but more recently generic and health-related QOL (HRQOL) measures have been developed . The early assessments of children's quality of life were mostly disease-specific, and this trend has continued. Generic HRQOL measurements for children and adolescents can help identify subgroups of children and adolescents who are at risk of developing health problems. KIDSCREEN-27 is a generic HRQOL measure derived from KIDSCREEN-52. The KIDSCREEN-27 is a subset of the KIDSCREEN-52 that includes 27 items for assessing HRQOL across five dimensions: Physical Well-Being (5 items) examines a child's or adolescent's level of physical activity, energy, and fitness. Although the psychometric properties of the Turkish version of the KIDSCREEN forms have been studied previously; however, its psychometric characteristics in children with CP have yet to be determined. Accordingly, the aim of this study is to provide an overview of the psychometric results of the KIDSCREEN-27 HRQOL questionnaire
Detailed description
Children with CP generally report a lower QOL than their normally developing peers. Quality of life (QOL) is now recognized as an important outcome of interventions because it relates to a person's individual cognition or well-being in a range of domains (e.g., physical, social, emotional, spiritual). Health-related quality of life (HRQOL) is a subdomain of the more global construct of QOL, including domains such as physical, mental, and social well-being Recently, there has been a surge in interest in assessing the quality of life (QOL) of children with cerebral palsy (CP). QOL instruments are increasingly used to assess the effectiveness of interventions for children with CP. To assess QOL, there are both generic and condition-specific scales available. The Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child), the Child Health Questionnaire (CHQ), European generic health related quality of life questionnaire (KIDSCREEN), and the Pediatric Quality of Life Inventory are some of the most used instruments. Out of these QOL instruments, European generic health related quality of life questionnaire (KIDSCREEN) is a generic QOL questionnaire and KIDSCREEN-27 is a shorter version of the KIDSCREEN-52 questionnaire to evaluate HRQOL outcomes of children and adolescents between the ages of 8-18 years. . Generic scales are useful for comparing groups since they are designed to be relevant to all subgroups of the population. Because they do not include domains that are relevant to the sickness or disability, they are less useful for evaluating the effectiveness of an intervention for children with that illness or disability. Condition-specific scales are useful for detecting changes in QOL for a given condition and are designed to be applicable to a group. Instruments that are condition-specific can capture the domains of QOL that are significant to children and adolescents with CP. Although the psychometric properties of KIDSCREEN-27 tests have been extensively studied in healthy children and adolescents, there has been no research to date on the psychometric features of KIDSCREEN-27 instruments in cerebral palsy children and adolescents. Thus, the aims of this study were to examine and determine the construct-concurrent validity and reliability of the Turkish version of the self and proxy versions of KIDSCREEN-27 questionnaire in individuals with cerebral palsy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with all typologies of cerebral palsy and their parents/caregivers
Key inclusion criteria (1 listed)
- Children with cerebral palsy who have sufficient intellectual level to answer KIDSCREEN-27' items
Key exclusion criteria (1 listed)
- children with severe intellectual disability
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 |
|---|---|---|
| No interventioncross-sectional study/psychometric study | Diagnostic test | – |
Primary outcome
Consistency from baseline in mean scores of KIDSCREEN-27 at week 2
Time frame: Change from Baseline KIDCREEN-27 mean scores at 2 weeks
The KIDSCREEN-27 is a 27-item variation of the KIDSCREEN-52 questionnaire that includes five dimensions of health-related quality of life (HRQOL). It is a valid and reliable tool for assessing children's and adolescents' HRQOL outcomes
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 3 Jun 2022.
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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.
Mintaze KEREM GUNLE study chair
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, run by Muş Alparslan 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 1 inclusion and 1 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 3 Jun 2022. 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?
Consistency from baseline in mean scores of KIDSCREEN-27 at week 2 (time frame: Change from Baseline KIDCREEN-27 mean scores at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2022.