Cerebral PalsyNCT06944171
Effects of Associated Impairments on Activity and Participation in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study will investigate the effects of associated impairments on the activity levels and social participation of school-aged children with Cerebral Palsy (aged 6-12) and their impact on their families' quality of life and caregiving burden. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 27 Jun 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with CPand their families who applied to Hacettepe University Faculty of Physical Therapy and Rehabilitation Cerebral Palsy and Pediatric Rehabilitation Unit and Ministry of National Education Keçiören Guidance and Research Center and agreed to participate in the study.
Who may be able to join
- Having a diagnosis of cerebral palsy
- Being between the ages of 6-12
- Having family approval for the study Exclusion criteria
- Being under the age of 6 and over the age of 12
- Parents and children who do not volunteer to participate in the study
- Not knowing Turkish
Show all 12Show fewer
- For families:
- Having a child between the ages of 6-12 diagnosed with cerebral palsy
- Being willing to participate in the study Exclusion criteria
- Not being willing to participate in the study
- Not knowing Turkish
- Not being able to read and write
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University Faculty of Physical Therapy and Rehabilitation Cerebral Palsy and Pediatric Rehabilitation Unit
Ankara, 06100
Faculty Dean's Office, 903123051577, ftr@hacettepe.edu.tr
About this study
Official title: Investigation of the Effects of Associated Impairments in School-Age Children With Cerebral Palsy on the Child's Activity and Participation Level and on Their Families
This study will investigate the effects of associated impairments on the activity levels and social participation of school-aged children with Cerebral Palsy (aged 6-12) and their impact on their families' quality of life and caregiving burden.
Read the detailed description
Cerebral Palsy (CP) defines a group of permanent disorders in movement and posture development, which are expressed as non-progressive disorders that occur in the developing baby brain during life in the womb or the first 3 years after birth, causing restrictions in activity and participation.
Hearing, speech, vision, cognitive, eating and swallowing problems and epilepsy primarily accompany the motor and postural control problems seen in CP. It is reported that cognitive disabilities or learning difficulties are seen in 50-75%, speech problems in 25%, hearing problems in 25%, seizures in 25-35% and visual disorders in 40-50% of individuals with CP. These primary problems, which accompany from the beginning, vary according to the clinical type and functional effect of CP and affect the severity of the existing CP clinical picture.
The International Classification of Functioning, Disability and Health (ICF) is a framework that guides the comprehensive assessment and treatment of children with CP by considering the wide range of health-related problems they face. The ICF includes four interrelated components: body structure and functions, activity and participation, and personal and environmental factors. According to the ICF, impairments are defined as significant deviations or losses in body structure and functions, while activity limitations, difficulties in activities, and participation restrictions are defined as problems in the form or scope of participation in life.
With these impairments added to the clinical picture, children with CP face significant limitations in their activity and participation levels. Therefore, it is important to define the relationship between comorbid impairments and activity and participation limitations in order to create holistic treatment goals and interventions that improve the activity and participation levels of children with CP.
According to the World Health Organization, quality of life, especially the health-related quality of life of parents of children with special needs, is a complex and comprehensive concept related to the physical health status, psychological status, independence level, social relationships, personal beliefs and environmental characteristics of the parents.
The care of children with CP is long-term and difficult. It has been reported that frequent hospital visits from the moment of diagnosis, the need for multidisciplinary therapy and the difficulty of the care process can lead to the parents not being able to spare time for themselves and their surroundings, economic difficulties and deterioration in their quality of life.
When the literature is examined, no study has been found that examines the multidimensional problems accompanying CP, especially with a sample from our country.
- Conditions
- Cerebral Palsy
- Keywords
- family, comorbidity, child, intellectual disability, cerebral palsy, epilepsy, seizures, vision disorders, hearing loss, speech disorders, caregiver, quality of life, activities of daily life, social participation
- Medical subject headings
- Cerebral Palsy, Intellectual Disability, Epilepsy, Seizures, Vision Disorders, Hearing Loss, Speech Disorders
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 |
|---|---|---|
| School-aged children with Cerebral Palsy | Children with cerebral palsy between the ages of 6 and 12 volunteered for the study | |
| Families with children with cerebral palsy | Parents of children with cerebral palsy between the ages of 6 and 12 volunteered for the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEDI-CAT (Pediatric Evaluation of Disability Inventory Computer Adaptive Test)
The PEDI-CAT measures abilities in three functional domains: Daily Activities, Mobility and Social/Cognitive. The PEDI-CAT's Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex, multi-step life tasks.
Measured: Single assessment conducted during the initial study visit
LIFE-H 3.0 (The Assessment of life habits)
The Assessment of life habits (LIFE-H) is a questionnaire that is used to collect information on all life habits that people carry out in their environment (home, workplace or school, neighborhood) to ensure their survival and development in society throughout their lifetime. LIFE-H uses a numerical scoring system ranging from 0 to 9. A score of 0 indicates a complete disability or impairment in participation, while a score of 9 indicates an optimal level of participation.
Measured: Single assessment conducted during the initial study visit
Secondary outcomes (2)
Nottingham Health Profile
NSP is a scale used to assess the quality of life of families with children with cerebral palsy. This profile was developed to measure the physical, emotional and social health status of individuals. The survey consists of 7 subsections and a total of 45 items. The answers to the questions are yes/no. The participant receives 0 points for each no answer and different points for each yes answer. The maximum score that can be obtained from the survey is 607. High scores indicate low quality of life, while low scores indicate high quality of life.
Measured: Single assessment conducted during the initial study visit
Impact on Family Scale (IPFAM)
It was developed to assess the burden of the child's illness on the family for families or caregivers of disabled children. It consists of five headings: 1) Economic burden, the extent to which the illness changes the family's economic situation, 2) Social impact, the quality and amount of interaction with other people outside the immediate family, 3) Familial impact, the quality of interaction within the family unit, 4) Personal difficulty, the subjective burden experienced by the primary caregiver, 5) Coping, the strategies used by the family to cope with the child's illness or disability. A four-point Likert-type assessment is scored from "4: I completely agree" to "1: I completely disagree." A low score from the survey indicates a high level of impact on the family.
Measured: Single assessment conducted during the initial study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start1 Oct 2024
- Primary completion20 Jun 2025 (estimated)
- Study completion27 Jun 2025 (estimated)
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.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 107 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Erdinler, Hacettepe University
- Investigators
- Mintaze Kerem-Gunel, Professor, Study director, Hacettepe University, Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944171
- Sponsor's protocol ID
- HU-FTR-EE-01
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants were informed, through the written informed consent form, that all personal data collected during the study would be kept strictly confidential and used solely for research purposes. The form also explained that their identities would not be revealed in any publication or report resulting from the study.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Associated Impairments in School-Age Children With Cerebral Palsy on the Child's Activity and Participation Level and on Their Families
- ClinicalTrials.gov ID
- NCT06944171
- Acronym / sponsor ID
- HU-FTR-EE-01
- Conditions
- Cerebral Palsy
- Keywords
- family, comorbidity, child, intellectual disability, cerebral palsy, epilepsy, seizures, vision disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 27 Jun 2025 (estimated)
- First posted
- 25 Apr 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.
This study will investigate the effects of associated impairments on the activity levels and social participation of school-aged children with Cerebral Palsy (aged 6-12) and their impact on their families' quality of life and caregiving burden.
Detailed description
Cerebral Palsy (CP) defines a group of permanent disorders in movement and posture development, which are expressed as non-progressive disorders that occur in the developing baby brain during life in the womb or the first 3 years after birth, causing restrictions in activity and participation.
Hearing, speech, vision, cognitive, eating and swallowing problems and epilepsy primarily accompany the motor and postural control problems seen in CP. It is reported that cognitive disabilities or learning difficulties are seen in 50-75%, speech problems in 25%, hearing problems in 25%, seizures in 25-35% and visual disorders in 40-50% of individuals with CP. These primary problems, which accompany from the beginning, vary according to the clinical type and functional effect of CP and affect the severity of the existing CP clinical picture.
The International Classification of Functioning, Disability and Health (ICF) is a framework that guides the comprehensive assessment and treatment of children with CP by considering the wide range of health-related problems they face. The ICF includes four interrelated components: body structure and functions, activity and participation, and personal and environmental factors. According to the ICF, impairments are defined as significant deviations or losses in body structure and functions, while activity limitations, difficulties in activities, and participation restrictions are defined as problems in the form or scope of participation in life.
With these impairments added to the clinical picture, children with CP face significant limitations in their activity and participation levels. Therefore, it is important to define the relationship between comorbid impairments and activity and participation limitations in order to create holistic treatment goals and interventions that improve the activity and participation levels of children with CP.
According to the World Health Organization, quality of life, especially the health-related quality of life of parents of children with special needs, is a complex and comprehensive concept related to the physical health status, psychological status, independence level, social relationships, personal beliefs and environmental characteristics of the parents.
The care of children with CP is long-term and difficult. It has been reported that frequent hospital visits from the moment of diagnosis, the need for multidisciplinary therapy and the difficulty of the care process can lead to the parents not being able to spare time for themselves and their surroundings, economic difficulties and deterioration in their quality of life.
When the literature is examined, no study has been found that examines the multidimensional problems accompanying CP, especially with a sample from our country.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School-aged children with Cerebral Palsy | – | –Children with cerebral palsy between the ages of 6 and 12 volunteered for the study |
| Families with children with cerebral palsy | – | –Parents of children with cerebral palsy between the ages of 6 and 12 volunteered for the study. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with CPand their families who applied to Hacettepe University Faculty of Physical Therapy and Rehabilitation Cerebral Palsy and Pediatric Rehabilitation Unit and Ministry of National Education Keçiören Guidance and Research Center and agreed to participate in the study.
Key inclusion criteria (12 listed)
- Having a diagnosis of cerebral palsy
- Being between the ages of 6-12
- Having family approval for the study Exclusion criteria
- Being under the age of 6 and over the age of 12
- Parents and children who do not volunteer to participate in the study
Key exclusion criteria (0 listed)
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
PEDI-CAT (Pediatric Evaluation of Disability Inventory Computer Adaptive Test)
Time frame: Single assessment conducted during the initial study visit
The PEDI-CAT measures abilities in three functional domains: Daily Activities, Mobility and Social/Cognitive. The PEDI-CAT's Responsibility domain measures the extent to which the caregiver or child takes responsibility for managing complex, multi-step life tasks.
LIFE-H 3.0 (The Assessment of life habits)
Time frame: Single assessment conducted during the initial study visit
The Assessment of life habits (LIFE-H) is a questionnaire that is used to collect information on all life habits that people carry out in their environment (home, workplace or school, neighborhood) to ensure their survival and development in society throughout their lifetime. LIFE-H uses a numerical scoring system ranging from 0 to 9. A score of 0 indicates a complete disability or impairment in participation, while a score of 9 indicates an optimal level of participation.
2 secondary outcomes
Nottingham Health Profile
Time frame: Single assessment conducted during the initial study visit
Impact on Family Scale (IPFAM)
Time frame: Single assessment conducted during the initial study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No. Participants were informed, through the written informed consent form, that all personal data collected during the study would be kept strictly confidential and used solely for research purposes. The form also explained that their identities would not be revealed in any publication or report resulting from the study.
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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.
Mintaze Kerem-Gunel, Professor study director
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
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 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 12 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 25 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra Erdinler (905318536594, eserdinler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PEDI-CAT (Pediatric Evaluation of Disability Inventory Computer Adaptive Test) (time frame: Single assessment conducted during the initial study visit). 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?
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 25 Apr 2025.