Cerebral PalsyCaregiver CPNCT06224322
Caregiver Burden in Cerebral Palsy Undergoing Hip and Knee Surgery
An observational study of Cerebral Palsy and Care Giving Burden, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this observational study was to obtain information about the change in the burden of care of parents of children with cerebral palsy after hip and knee surgeries. The main questions it aims to answer are: Q1-Does caregiver burden change after hip and knee surgeries? Q2-If so, which factors contribute more… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Care Giving Burden
- What is being tested?
- Assesment Scale
- How many people
- 45 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Sep 2024
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Our study will be conducted with the parents of children with cerebral palsy who are admitted to the Orthopaedics Unit of Istanbul Medical Faculty and will be operated on in the knee-hip region.
Who may be able to join
- Parent Age
- Being in the 20-60 age group.
- Diagnosis
- Having a child with clinically diagnosed cerebral palsy
- The movement scale of the cerebral palsy patient is between GMFS 3 and 5
- A minimum follow-up of 12 months after surgery
- The primary carer is the mother or father
Who cannot join
- The patient and his/her family have been lost to follow-up
- Having another disabled person in need of care in the family
- Family's unwillingness to participate in the study
- Loss of a parent
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Department of Orthopaedics and Traumatology, Istanbul University, Istanbul, Turkey
Istanbul, Fatih-Topkapı, 34080
Ahmet M YILDIRIM, Assistant, 090 212 414 2000 ext. 31516, ahmet.yildirim.93@istanbul.edu.tr
- Recruiting
Istanbul Unıversity Medicine Faculty Orthopaedic Department
Istanbul, Fatih, 34080
Ahmet Muçteba AM Yıldırım, Fellow, +090 534 303 8472, mucceba@gmail.com
About this study
Official title: Evaluation of Factors Affecting Caregiver Burden in Cerebral Palsy Patients Undergoing Hip and Knee Surgery
The aim of this observational study was to obtain information about the change in the burden of care of parents of children with cerebral palsy after hip and knee surgeries. The main questions it aims to answer are:
Q1-Does caregiver burden change after hip and knee surgeries? Q2-If so, which factors contribute more positively to this situation? Participants will be asked to answer the scales given to them periodically before and after the surgery.
Read the detailed description
One of the most common causes of disability in childhood is cerebral palsy, which develops due to damage to the central nervous system. Children diagnosed with cerebral palsy face different problems in every period of their lives. The child, his/her family and the society he/she lives in should be considered as a whole. There is a mechanism that mutually affects each other.
Parenting, caring for and living with a child with cerebral palsy can have many negative effects on the lives of parents and create additional burdens for them. Parents may have to choose between their own needs, the needs of other members of the family and the needs of the child with cerebral palsy, and may spend most of their time with their disabled child. This can negatively affect the burden, stress level, physical activity level, quality of life, psychological status and self-efficacy perception.
The primary aim of this study is to evaluate the caregiver burden in Cerebral Palsy, which is the most common cause of morbidity in the pediatric age group in orthopedics, and to analyze the factors that negatively affect it. Our hypothesis is that the functional mobilization status of patients will increase, especially as a result of hip surgeries, reducing caregiver burden.
- Conditions
- Cerebral Palsy, Care Giving Burden
- Being tested
- Assesment Scale
- Medical subject headings
- Cerebral Palsy, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assesment ScaleOther
Also called Questionnaire
Caregiving burden will be assessed with Turkish validated scoring tools such as the Zarit scale and the Pediatric Quality of Life Inventory (PEDSQL) Family Impacts module before and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Palsy Patients Parent | Parents of patients who underwent knee and hip surgery for cerebral palsy Receives: Other: Assesment Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Caregiven Burden scale
The 22-item instrument is included in this scale. Each item in the questionnaire is a statement that the carer is asked to confirm using a 5-point scale. The answer options range from 0 (Never) to 4 (Almost Always).
Measured: Preoperative, Postoperative three, six and twelve month
Secondary outcomes (1)
Pediatric Quality of Life Inventory (PEDSQL) Family Impacts module
This scale was developed by James James in 2004 to measure the effects of a child with an illness on family functioning. It was developed by Varni. It consists of 6 sub-factors and 36 statements. Physical Functioning (6 items), 2) Emotional Functioning (5 items), 3) Social Functioning (4 items), 4) Cognitive Functioning (5 items), 5) Communication (3 items), 6) Concern (5 items) and 2 subscales measuring parent-reported family functioning; 7) Daily Activities (3 items) and Family Relationships (5 items).
Measured: Preoperative, Postoperative three, six and twelve month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Jun 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Sep 2024 (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 Istanbul 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMET MUCTEBA YILDIRIM, Istanbul University
- Investigators
- Mehmet MD Demirel, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224322
- Sponsor's protocol ID
- 2234234
- Acronym
- Caregiver CP
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Maybe one year later ı am going to share ıpd
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Factors Affecting Caregiver Burden in Cerebral Palsy Patients Undergoing Hip and Knee Surgery
- ClinicalTrials.gov ID
- NCT06224322
- Acronym / sponsor ID
- Caregiver CP / 2234234
- Conditions
- Cerebral Palsy, Care Giving Burden
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 25 Jan 2024 (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.
The aim of this observational study was to obtain information about the change in the burden of care of parents of children with cerebral palsy after hip and knee surgeries. The main questions it aims to answer are:
Q1-Does caregiver burden change after hip and knee surgeries? Q2-If so, which factors contribute more positively to this situation? Participants will be asked to answer the scales given to them periodically before and after the surgery.
Detailed description
One of the most common causes of disability in childhood is cerebral palsy, which develops due to damage to the central nervous system. Children diagnosed with cerebral palsy face different problems in every period of their lives. The child, his/her family and the society he/she lives in should be considered as a whole. There is a mechanism that mutually affects each other.
Parenting, caring for and living with a child with cerebral palsy can have many negative effects on the lives of parents and create additional burdens for them. Parents may have to choose between their own needs, the needs of other members of the family and the needs of the child with cerebral palsy, and may spend most of their time with their disabled child. This can negatively affect the burden, stress level, physical activity level, quality of life, psychological status and self-efficacy perception.
The primary aim of this study is to evaluate the caregiver burden in Cerebral Palsy, which is the most common cause of morbidity in the pediatric age group in orthopedics, and to analyze the factors that negatively affect it. Our hypothesis is that the functional mobilization status of patients will increase, especially as a result of hip surgeries, reducing caregiver burden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral Palsy Patients Parent | – | Other: Assesment ScaleParents of patients who underwent knee and hip surgery for cerebral palsy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Our study will be conducted with the parents of children with cerebral palsy who are admitted to the Orthopaedics Unit of Istanbul Medical Faculty and will be operated on in the knee-hip region.
Key inclusion criteria (7 listed)
- Parent Age
- Diagnosis
- A minimum follow-up of 12 months after surgery
- The primary carer is the mother or father
Key exclusion criteria (4 listed)
- The patient and his/her family have been lost to follow-up
- Having another disabled person in need of care in the family
- Family's unwillingness to participate in the study
- Loss of a parent
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 |
|---|---|---|
| Assesment ScaleAlso: QuestionnaireCaregiving burden will be assessed with Turkish validated scoring tools such as the Zarit scale and the Pediatric Quality of Life Inventory (PEDSQL) Family Impacts module before and after surgery. | Other | Cerebral Palsy Patients Parent |
Primary outcome
Zarit Caregiven Burden scale
Time frame: Preoperative, Postoperative three, six and twelve month
The 22-item instrument is included in this scale. Each item in the questionnaire is a statement that the carer is asked to confirm using a 5-point scale. The answer options range from 0 (Never) to 4 (Almost Always).
1 secondary outcome
Pediatric Quality of Life Inventory (PEDSQL) Family Impacts module
Time frame: Preoperative, Postoperative three, six and twelve month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: No. Maybe one year later ı am going to share ıpd
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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.
Mehmet MD Demirel, MD principal investigator
Assistant Professor
2 sites 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 Care Giving Burden, run by Istanbul University at 2 sites 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Muçteba AM Yıldırım, Fellow (+090 534 3038472, mucceba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit Caregiven Burden scale (time frame: Preoperative, Postoperative three, six and twelve month). 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 26 Jan 2024.