Cerebral PalsyNCT06572787
Family Centered Services in Cerebral Palsy
An observational study of Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
To examine the family-centered service characteristics of physiotherapy and rehabilitation services received by children with cerebral palsy (CP) and to investigate the affecting factors. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2023to 27 May 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children diagnosed with cerebral palsy between the ages of 2 and 18 who have received physiotherapy and rehabilitation services for at least one year and their parents
Who may be able to join
- Having a child aged between 2 and 18 years diagnosed with cerebral palsy
- Receiving physiotherapy and rehabilitation services for at least one year
- The family's consent to participate in the study and their approval for their child to be assessed by the researcher physiotherapist and for their information to be collected within the scope of the study
Who cannot join
- Parents over the age of 65
- Parents who do not speak Turkish
- Having another child with a disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Family Centered Service in the Physiotherapy and Rehabilitation Processes of Children with Cerebral Palsy
To examine the family-centered service characteristics of physiotherapy and rehabilitation services received by children with cerebral palsy (CP) and to investigate the affecting factors.
Read the detailed description
Children with Cerebral Palsy (CP) attend special education and rehabilitation centers to receive physiotherapy and rehabilitation (PT) services, and it is very important for parents to be informed about the services offered in these centers. Our aim in the study was to examine which factors affect family-centered characteristics and parental perceptions in the PT services received by children with CP. For this purpose, 100 children diagnosed with CP between the ages of 2-18 and their parents were included in the study. The Measure of Processes Care (MPOC) survey was used to assess parents' perceptions of the family-centered features of (PT) services. These perceptions were examined to determine whether they vary depending on the child's age, functional level, parents' educational status, the impact of their disabled children, and health-related quality of life. The Family Impact Scale was used to measure parents' level of influence from their disabled children, and the Nottingham Health Profile survey was used to evaluate their health-related quality of life.
- Conditions
- Cerebral Palsy
- Keywords
- Physiotherapy, Rehabilitation, Family Centered Services, Impact Family, Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Processus of Care
Measure of Processus of Care-20 (MPOC-20) survey was administered to assess parents' perceptions of the family-centered features of physiotherapy and rehabilitation services. The appropriate answers to the questions in the survey are marked with a number from 1 (strongly disagree) to 7 (strongly agree). A value of zero (0) indicated not personally relevant.
Measured: 3 months
Secondary outcomes (2)
Impact on Family Scale
The Impact on Family of Scale (IPFAM) scale was used to determine impact of the child with CP on parents. IPFAM consists of 33 items in total. The family's level of involvement is measured under 5 headings.The scale has a Likert-type evaluation ranging from 1 to 4. A low score from the survey indicates a high level of family involvement
Measured: 3 months
Nottingham Health Profile
The Nottingham Health Profile (NHP) was used to measure parents' health-related quality of life. NHP is a scale used to assess quality of life. This profile was developed to measure the physical, emotional and social health status of individuals. The questionnaire consists of 7 subsections and a total of 45 items. The maximum score that can be obtained from the questionnaire is 607. High scores indicate low quality of life and low scores indicate high quality of life
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start20 Oct 2023
- Primary completion20 Apr 2024
- Study completion27 May 2024
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ocalan, Hacettepe University
- Investigators
- Mustafa Öcalan, MSc, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572787
- Sponsor's protocol ID
- HACETTEPEU-SBF-MO-01
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Family Centered Service in the Physiotherapy and Rehabilitation Processes of Children with Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06572787
- Acronym / sponsor ID
- HACETTEPEU-SBF-MO-01
- Conditions
- Cerebral Palsy
- Keywords
- Physiotherapy, Rehabilitation, Family Centered Services, Impact Family, Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 27 Aug 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.
To examine the family-centered service characteristics of physiotherapy and rehabilitation services received by children with cerebral palsy (CP) and to investigate the affecting factors.
Detailed description
Children with Cerebral Palsy (CP) attend special education and rehabilitation centers to receive physiotherapy and rehabilitation (PT) services, and it is very important for parents to be informed about the services offered in these centers. Our aim in the study was to examine which factors affect family-centered characteristics and parental perceptions in the PT services received by children with CP. For this purpose, 100 children diagnosed with CP between the ages of 2-18 and their parents were included in the study. The Measure of Processes Care (MPOC) survey was used to assess parents' perceptions of the family-centered features of (PT) services. These perceptions were examined to determine whether they vary depending on the child's age, functional level, parents' educational status, the impact of their disabled children, and health-related quality of life. The Family Impact Scale was used to measure parents' level of influence from their disabled children, and the Nottingham Health Profile survey was used to evaluate their health-related quality of life.
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
- Children diagnosed with cerebral palsy between the ages of 2 and 18 who have received physiotherapy and rehabilitation services for at least one year and their parents
Key inclusion criteria (3 listed)
- Having a child aged between 2 and 18 years diagnosed with cerebral palsy
- Receiving physiotherapy and rehabilitation services for at least one year
- The family's consent to participate in the study and their approval for their child to be assessed by the researcher physiotherapist and for their information to be collected within the scope of the study
Key exclusion criteria (3 listed)
- Parents over the age of 65
- Parents who do not speak Turkish
- Having another child with a disability
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
Measure of Processus of Care
Time frame: 3 months
Measure of Processus of Care-20 (MPOC-20) survey was administered to assess parents' perceptions of the family-centered features of physiotherapy and rehabilitation services. The appropriate answers to the questions in the survey are marked with a number from 1 (strongly disagree) to 7 (strongly agree). A value of zero (0) indicated not personally relevant.
2 secondary outcomes
Impact on Family Scale
Time frame: 3 months
Nottingham Health Profile
Time frame: 3 months
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 5 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Mustafa Öcalan, MSc 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, 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 3 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 5 Sep 2024. 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?
Measure of Processus of Care (time frame: 3 months). 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 5 Sep 2024.