Health-Related Quality-of-LifeNCT07211594
HEALTH-RELATED QUALITY OF LIFE IN CEREBRAL PALSY: AGREEMENT BETWEEN ADOLESCENTS, CAREGIVERS AND PHYSIOTHERAPISTS
An observational study of Health-Related Quality-of-Life and Adolescent, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Health-related quality of life (HRQoL) has recently become a widely used outcome measure. Although self-reporting is considered the gold standard, proxy reports are commonly used for adolescents with cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Health-Related Quality-of-Life, Adolescent, Cerebral Palsy (CP)
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2018to 18 Feb 2020
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The demographic information such as weight, height, sex, age etc. were recorded for adolescents, as well as the age and educational status of the caregivers. Gross Motor Function Classification System (GMFCS-E\&R) were used to classify the adolescents' gross motor function. The hand function of adolescents in daily activities was classified with The Manual Ability Classification System (MACS), and the communication of adolescents was classified with the Communication Function Classification System (CFCS). Clinicians and researchers used these classification systems to grade functional capacity systems and constitute a common language to describe function.
Who may be able to join
- being diagnosed with CP of all clinical types,
- aged 11-18 years,
- who can understand and answer the questions.
Who cannot join
- Adolescents who did not attend regular therapy sessions
- Physiotherapists who performed therapy sessions with the adolescent for less than four weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HEALTH-RELATED QUALITY OF LIFE OF ADOLESCENTS WITH CEREBRAL PALSY: AGREEMENT BETWEEN ADOLESCENTS, CAREGIVERS AND PHYSIOTHERAPISTS
Health-related quality of life (HRQoL) has recently become a widely used outcome measure. Although self-reporting is considered the gold standard, proxy reports are commonly used for adolescents with cerebral palsy (CP).
Study Question: Is there agreement between adolescents, caregivers and physiotherapists in health-related quality of life reports in adolescents with cerebral palsy?
Read the detailed description
Cerebral palsy are often accompanied by sensory, perceptual, developmental, and behavioral problems, as well as epilepsy and secondary musculoskeletal disorders. As a result of these impairments, children and adolescents with CP have functional limitation that affect their daily lives. These limitations adversely affect their quality of life depending on the severity of functional impairments. Health-related quality of life is conceptualized as an individual's subjective evaluation of life domains that are perceived to be influenced by a medical condition or its treatment. Informed by the International Classification of Functioning, Disability and Health (ICF) and the socio-ecological model, the primary aim of interventions for individuals with cerebral palsy and their families should be to enhance quality of life. Previous research has shown that the level of agreement on HRQoL between physicians and adolescents is generally lower than that between parents and adolescents. When the caregiver is more familiar with the adolescent with CP-such as a parent rather than a medical professional-the likelihood of agreement between the adolescent and the caregiver tends to be higher. Agreement on target problems is essential for effective treatment planning. Differences between adolescents and their caregivers can influence treatment decisions; thus, combining self- and proxy-reports offers a more comprehensive assessment of HRQoL. Therefore, a multi-informant approach, considered the gold standard in CP research and practice, integrates reports from children, parents, and when appropriate professionals such as teachers or clinicians, providing a comprehensive assessment of the child's quality of life across different contexts.
Another important issue in measuring quality of life in individuals with CP is that the scales used should address CP-specific concerns. Therefore, using CP-specific measurement tools is recommended to provide clearer outcomes for intervention processes. Although research has compared the quality of life perspectives of children and adolescents with CP and their parents, there remains a lack of studies investigating the agreement between reports from adolescents with CP, their parents, and the professionals involved in their care. The main objective of this study is to assess the agreement and differences between the views of adolescents with CP, their families.
- Keywords
- health-related quality of life, cerebral palsy (CP), adolescent
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with cerebral palsy | The study was conducted with 97 adolescents CP attending Hacettepe University Physiotherapy and Rehabilitation Department's Pediatric Rehabilitation together with their caregivers. | |
| Caregivers of adolescent with cerebral palsy | Caregivers of adolescent with cerebral palsy who may be parents, grandparents or caregivers. | |
| the physiotherapist who conducts the adolescent rehabilitation process. | pediatric physiotherapists working in the field of pediatric rehabilitation especially with cerebral palsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life: The Pediatric Quality of Life Inventory (PedsQL) Measurement Tool
PedsQL was designed to evaluate HR-QOL in generic and disease-specific situations with disease-specific modules in children and adolescents between 2-18 years old. The PedsQL 3.0 CP Module was designed to measure HR-QOL dimensions specific to CP. PedsQL 3.0 CP encompasses 35-item in Module seven scales: (1) Daily Activities (9 items); (2) School Activities (4 items); (3) Movement and Balance (5 items); (4) Pain and Hurt (4 items); (5) Fatigue (4 items); (6) Eating Activities (5 items); and (7) Speech and Communication (4 items). The Scales are included in parallel adolescent self-report and parent proxy-report formats. A 5-point Likert scale is used across adolescent self-reports for ages 8 to 18 years and parent proxy reports (0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem). Items are reverse scored and transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0) so that higher scores indicate better HRQOL.
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start18 Oct 2018
- Primary completion18 May 2019
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health-Related Quality-of-LifeStudies 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
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mintaze Kerem Gunel, Hacettepe University
- Investigators
- Mintaze Kerem Gunel, Prof. Dr., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211594
- Sponsor's protocol ID
- GO 18/876-02
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication.
Publications
Sentenac M, Rapp M, Ehlinger V, Colver A, Thyen U, Arnaud C. Disparity of child/parent-reported quality of life in cerebral palsy persists into adolescence. Dev Med Child Neurol. 2021 Jan;63(1):68-74. doi: 10.1111/dmcn.14638. Epub 2020 Jul 25.
PubMed 32710687Morrow AM, Hayen A, Quine S, Scheinberg A, Craig JC. A comparison of doctors', parents' and children's reports of health states and health-related quality of life in children with chronic conditions. Child Care Health Dev. 2012 Mar;38(2):186-95. doi: 10.1111/j.1365-2214.2011.01240.x. Epub 2011 Jun 8.
PubMed 21651605Aza A, Riquelme I, Gomez Vela M, Badia M. Proxy- and self-report evaluation of quality of life in cerebral palsy: Using Spanish version of CPQOL for Children and adolescents. Res Dev Disabil. 2024 Nov;154:104844. doi: 10.1016/j.ridd.2024.104844. Epub 2024 Sep 24.
PubMed 39321691
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEALTH-RELATED QUALITY OF LIFE OF ADOLESCENTS WITH CEREBRAL PALSY: AGREEMENT BETWEEN ADOLESCENTS, CAREGIVERS AND PHYSIOTHERAPISTS
- ClinicalTrials.gov ID
- NCT07211594
- Acronym / sponsor ID
- GO 18/876-02
- Keywords
- health-related quality of life, cerebral palsy (CP), adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 18 May 2019 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 8 Oct 2025 (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.
Health-related quality of life (HRQoL) has recently become a widely used outcome measure. Although self-reporting is considered the gold standard, proxy reports are commonly used for adolescents with cerebral palsy (CP).
Study Question: Is there agreement between adolescents, caregivers and physiotherapists in health-related quality of life reports in adolescents with cerebral palsy?
Detailed description
Cerebral palsy are often accompanied by sensory, perceptual, developmental, and behavioral problems, as well as epilepsy and secondary musculoskeletal disorders. As a result of these impairments, children and adolescents with CP have functional limitation that affect their daily lives. These limitations adversely affect their quality of life depending on the severity of functional impairments. Health-related quality of life is conceptualized as an individual's subjective evaluation of life domains that are perceived to be influenced by a medical condition or its treatment. Informed by the International Classification of Functioning, Disability and Health (ICF) and the socio-ecological model, the primary aim of interventions for individuals with cerebral palsy and their families should be to enhance quality of life. Previous research has shown that the level of agreement on HRQoL between physicians and adolescents is generally lower than that between parents and adolescents. When the caregiver is more familiar with the adolescent with CP-such as a parent rather than a medical professional-the likelihood of agreement between the adolescent and the caregiver tends to be higher. Agreement on target problems is essential for effective treatment planning. Differences between adolescents and their caregivers can influence treatment decisions; thus, combining self- and proxy-reports offers a more comprehensive assessment of HRQoL. Therefore, a multi-informant approach, considered the gold standard in CP research and practice, integrates reports from children, parents, and when appropriate professionals such as teachers or clinicians, providing a comprehensive assessment of the child's quality of life across different contexts.
Another important issue in measuring quality of life in individuals with CP is that the scales used should address CP-specific concerns. Therefore, using CP-specific measurement tools is recommended to provide clearer outcomes for intervention processes. Although research has compared the quality of life perspectives of children and adolescents with CP and their parents, there remains a lack of studies investigating the agreement between reports from adolescents with CP, their parents, and the professionals involved in their care. The main objective of this study is to assess the agreement and differences between the views of adolescents with CP, their families.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adolescents with cerebral palsy | – | –The study was conducted with 97 adolescents CP attending Hacettepe University Physiotherapy and Rehabilitation Department's Pediatric Rehabilitation together with their caregivers. |
| Caregivers of adolescent with cerebral palsy | – | –Caregivers of adolescent with cerebral palsy who may be parents, grandparents or caregivers. |
| the physiotherapist who conducts the adolescent rehabilitation process. | – | –pediatric physiotherapists working in the field of pediatric rehabilitation especially with cerebral palsy |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The demographic information such as weight, height, sex, age etc. were recorded for adolescents, as well as the age and educational status of the caregivers. Gross Motor Function Classification System (GMFCS-E\&R) were used to classify the adolescents' gross motor function. The hand function of adolescents in daily activities was classified with The Manual Ability Classification System (MACS), and the communication of adolescents was classified with the Communication Function Classification System (CFCS). Clinicians and researchers used these classification systems to grade functional capacity systems and constitute a common language to describe function.
Key inclusion criteria (3 listed)
- being diagnosed with CP of all clinical types,
- aged 11-18 years,
- who can understand and answer the questions.
Key exclusion criteria (2 listed)
- Adolescents who did not attend regular therapy sessions
- Physiotherapists who performed therapy sessions with the adolescent for less than four weeks
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
Health-Related Quality of Life: The Pediatric Quality of Life Inventory (PedsQL) Measurement Tool
Time frame: 5-10 minutes
PedsQL was designed to evaluate HR-QOL in generic and disease-specific situations with disease-specific modules in children and adolescents between 2-18 years old. The PedsQL 3.0 CP Module was designed to measure HR-QOL dimensions specific to CP. PedsQL 3.0 CP encompasses 35-item in Module seven scales: (1) Daily Activities (9 items); (2) School Activities (4 items); (3) Movement and Balance (5 items); (4) Pain and Hurt (4 items); (5) Fatigue (4 items); (6) Eating Activities (5 items); and (7) Speech and Communication (4 items). The Scales are included in parallel adolescent self-report and parent proxy-report formats. A 5-point Likert scale is used across adolescent self-reports for ages 8 to 18 years and parent proxy reports (0=never a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem). Items are reverse scored and transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0) so that higher scores indicate better HRQOL.
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 8 Oct 2025.
- Background: PubMed 32710687Sentenac M, Rapp M, Ehlinger V, Colver A, Thyen U, Arnaud C. Disparity of child/parent-reported quality of life in cerebral palsy persists into adolescence. Dev Med Child Neurol. 2021 Jan;63(1):68-74. doi: 10.1111/dmcn.14638. Epub 2020 Jul 25.
- Background: PubMed 21651605Morrow AM, Hayen A, Quine S, Scheinberg A, Craig JC. A comparison of doctors', parents' and children's reports of health states and health-related quality of life in children with chronic conditions. Child Care Health Dev. 2012 Mar;38(2):186-95. doi: 10.1111/j.1365-2214.2011.01240.x. Epub 2011 Jun 8.
- Background: PubMed 39321691Aza A, Riquelme I, Gomez Vela M, Badia M. Proxy- and self-report evaluation of quality of life in cerebral palsy: Using Spanish version of CPQOL for Children and adolescents. Res Dev Disabil. 2024 Nov;154:104844. doi: 10.1016/j.ridd.2024.104844. Epub 2024 Sep 24.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication.
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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 Gunel, Prof. Dr. study director
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 Health-Related Quality-of-Life and Adolescent, 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 3 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 8 Oct 2025. 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?
Health-Related Quality of Life: The Pediatric Quality of Life Inventory (PedsQL) Measurement Tool (time frame: 5-10 minutes). 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 NCT07211594, which also lists 3 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 8 Oct 2025.