Cerebral PalsyCoPoCPHPNCT04813393
Compliance of Parents of Children With Cerebral Palsy to Home Program Questionnaire
An observational study of Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the psychometric properties of the Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q), a caregiver-report for adherence and frequency of home program implementation of parents of children with Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Questionnaire Development
- How many people
- 225 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 10 Sep 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants in the current study were parents of chlidren with 2 to 18 years and recruited at Hecettepe Univercity Physical Therapy and Rehabilitation Faculty Cerebral Palsy and Pediatric Rehabilitation Unit.
Who may be able to join
- having a child with CP 2 to 18 years,
- being a primary caregiver,
- understanding of Turkish without an interpreter, and Turkish literacy,
Who cannot join
- having any chronic illness or disability to prevent the home program,
- haven't applied home program before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychometric Properties of Compliance of Parents of Children With Cerebral Palsy to Home Program Questionnaire
This study aims to evaluate the psychometric properties of the Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q), a caregiver-report for adherence and frequency of home program implementation of parents of children with Cerebral Palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Questionnaire Development
- Keywords
- home program, cerebral palsy, questionnaire development, parent
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire DevelopmentOther
To evaluate psychometric the properties of the Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q), a caregiver-report for adherence and frequency of home program implementation of parents of children with Cerebral Palsy.
| Study group | Role | What they receive |
|---|---|---|
| Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire Group | The CPHP-Q was administered as a caregiver-report questionnaire. It aims to measure home program adherence of parents of children with CP. Parents applied this instrument in the study. Receives: Other: Questionnaire Development |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q)
The CPHP-Q was administered as a caregiver-report questionnaire. It aims to measure home program adherence of parents of children with CP. İt consist of 22 items. The highest score 110, the lowest score 22.
Measured: At baseline
Secondary outcomes (1)
Assessment of Life Habits for Children questionnaire (LIFE-H)
The questionnaire was designed and validated to assess the social participation of children with disabilities. It consists of 11 category: nutrition, physical fitness, personal care, mobility, interpersonal communication, social roles, education, recreational activities, responsibilities, housing, and social life. Each Life-H item is ranked on a 0 to 9 scale for accomplishment, where a score of 0 represents "not accomplished" and a score of 9 equals "no difficulty and no assistance."
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Jun 2020
- Primary completion1 Sep 2020
- Study completion10 Sep 2020
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
- Family based
- Time perspective
- Prospective
- Enrolment
- 225 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
- Mutlu Hayran, PhD, Study chair, Hacettepe UnivercityMeltem Şengelen, PhD, Study chair, Hacettepe Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813393
- Sponsor's protocol ID
- GO: 20/357
- Acronym
- CoPoCPHP
- Status last verified
- Mar 2021
- First submitted
- 21 Mar 2021
- Last updated
- 29 Mar 2021
- 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 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of Compliance of Parents of Children With Cerebral Palsy to Home Program Questionnaire
- ClinicalTrials.gov ID
- NCT04813393
- Acronym / sponsor ID
- CoPoCPHP / GO: 20/357
- Conditions
- Cerebral Palsy
- Keywords
- home program, cerebral palsy, questionnaire development, parent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 24 Mar 2021 (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 aims to evaluate the psychometric properties of the Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q), a caregiver-report for adherence and frequency of home program implementation of parents of children with Cerebral Palsy.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire Group | – | Other: Questionnaire DevelopmentThe CPHP-Q was administered as a caregiver-report questionnaire. It aims to measure home program adherence of parents of children with CP. Parents applied this instrument in the study. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants in the current study were parents of chlidren with 2 to 18 years and recruited at Hecettepe Univercity Physical Therapy and Rehabilitation Faculty Cerebral Palsy and Pediatric Rehabilitation Unit.
Key inclusion criteria (3 listed)
- having a child with CP 2 to 18 years,
- being a primary caregiver,
- understanding of Turkish without an interpreter, and Turkish literacy,
Key exclusion criteria (2 listed)
- having any chronic illness or disability to prevent the home program,
- haven't applied home program before.
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 |
|---|---|---|
| Questionnaire DevelopmentTo evaluate psychometric the properties of the Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q), a caregiver-report for adherence and frequency of home program implementation of parents of children with Cerebral Palsy. | Other | Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire Group |
Primary outcome
Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q)
Time frame: At baseline
The CPHP-Q was administered as a caregiver-report questionnaire. It aims to measure home program adherence of parents of children with CP. İt consist of 22 items. The highest score 110, the lowest score 22.
1 secondary outcome
Assessment of Life Habits for Children questionnaire (LIFE-H)
Time frame: At baseline
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 29 Mar 2021.
- 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.
Mutlu Hayran, PhD study chair
Hacettepe Univercity
Meltem Şengelen, PhD study chair
Hacettepe Univercity
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 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 29 Mar 2021. 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?
Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q) (time frame: At baseline). 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 29 Mar 2021.