Cerebral PalsyNCT03848936
Evaluation of Functional Status and Mental Functions of Adult Cerebral Palsy Patients
An observational study of Cerebral Palsy, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
In adult cerebral palsy patients , a questionnaire study will be conducted to determine the functional level and to determine the effect on quality of life. In this survey, age, gender, demographic information of the patient, as well as additional diseases which can be seen together with cerebral palsy will be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Survey
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2018to 30 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cerebral palsy patients
Who may be able to join
- >18 years old
- Diagnosed with cerebral palsy
- Who voluntarily participate the study
Who cannot join
- <18 years old
- Who does not give permission to participate the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
Istanbul, 34732
Bilinç Doğruöz Karatekin, +905368308709, bilincdogruoz@hotmail.com
Bilinç Doğruöz Karatekin, MD
About this study
In adult cerebral palsy patients , a questionnaire study will be conducted to determine the functional level and to determine the effect on quality of life. In this survey, age, gender, demographic information of the patient, as well as additional diseases which can be seen together with cerebral palsy will be questioned.
Read the detailed description
In adult patients diagnosed with cerebral palsy, a questionnaire study will be conducted to determine the functional level and to determine the effect on quality of life. In this survey, age, gender, demographic information of the patient, as well as additional diseases which can be seen together with cerebral palsy will be questioned. There are studies about the functional status of adults with CP in the literature; However, there is no study conducted on this subject in our country. In this study, it was aimed to evaluate the functional status and mental functions of adults with CP who applied to our hospital.
- Conditions
- Cerebral Palsy
- Being tested
- Survey
- Keywords
- adult cerebral palsy, cerebral palsy, functional status, mental function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey includes age, gender, cerebral palsy type, education, mental status, working status, living conditions, comorbidities, pain, spasticity, contractures, deformities, mobility status and gross motor function classification system level
| Study group | Role | What they receive |
|---|---|---|
| adult cerebral palsy patients | >18 age cerebral palsy diagnosed patients evaluated with a survey. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status of adult cerebral palsy patients
Evaluated with living status (alone/ with family / with / with spouse / with carer)
Measured: 1 year
Functional status of adult cerebral palsy patients
Evaluated with working status (no, part-time, full-time)
Measured: 1 year
Functional status of adult cerebral palsy patients
Evaluated with comorbidities
Measured: 1 year
Functional status of adult cerebral palsy patients
Evaluated with spasticity (yes or no)
Measured: 1 year
Functional status of adult cerebral palsy patients
Evaluated with deformity and contractures ( no, mild, moderate, severe)
Measured: 1 year
Functional status of adult cerebral palsy patients
Evaluated with pain status (yes or no)
Measured: 1 year
Functional status of adult cerebral palsy patients
Evaluated with mobility status ( 5 degrees )
Measured: 1 year
Mental status of adult cerebral palsy patients
Mental status simply classified as normal/minor/moderate/severe mental retardation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start20 Feb 2018
- Primary completion20 Feb 2019 (estimated)
- Study completion30 Apr 2019 (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.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848936
- Sponsor's protocol ID
- Medeniyet CP
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2019
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional Status and Mental Functions of Adult Cerebral Palsy Patients
- ClinicalTrials.gov ID
- NCT03848936
- Acronym / sponsor ID
- Medeniyet CP
- Conditions
- Cerebral Palsy
- Keywords
- adult cerebral palsy, cerebral palsy, functional status, mental function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 20 Feb 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 21 Feb 2019 (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.
In adult cerebral palsy patients , a questionnaire study will be conducted to determine the functional level and to determine the effect on quality of life. In this survey, age, gender, demographic information of the patient, as well as additional diseases which can be seen together with cerebral palsy will be questioned.
Detailed description
In adult patients diagnosed with cerebral palsy, a questionnaire study will be conducted to determine the functional level and to determine the effect on quality of life. In this survey, age, gender, demographic information of the patient, as well as additional diseases which can be seen together with cerebral palsy will be questioned. There are studies about the functional status of adults with CP in the literature; However, there is no study conducted on this subject in our country. In this study, it was aimed to evaluate the functional status and mental functions of adults with CP who applied to our hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult cerebral palsy patients | – | Other: Survey>18 age cerebral palsy diagnosed patients evaluated with a survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cerebral palsy patients
Key inclusion criteria (3 listed)
- >18 years old
- Diagnosed with cerebral palsy
- Who voluntarily participate the study
Key exclusion criteria (2 listed)
- <18 years old
- Who does not give permission to participate the study
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 |
|---|---|---|
| SurveySurvey includes age, gender, cerebral palsy type, education, mental status, working status, living conditions, comorbidities, pain, spasticity, contractures, deformities, mobility status and gross motor function classification system level | Other | adult cerebral palsy patients |
Primary outcome
Functional status of adult cerebral palsy patients
Time frame: 1 year
Evaluated with living status (alone/ with family / with / with spouse / with carer)
Functional status of adult cerebral palsy patients
Time frame: 1 year
Evaluated with working status (no, part-time, full-time)
Functional status of adult cerebral palsy patients
Time frame: 1 year
Evaluated with comorbidities
Functional status of adult cerebral palsy patients
Time frame: 1 year
Evaluated with spasticity (yes or no)
Functional status of adult cerebral palsy patients
Time frame: 1 year
Evaluated with deformity and contractures ( no, mild, moderate, severe)
Functional status of adult cerebral palsy patients
Time frame: 1 year
Evaluated with pain status (yes or no)
Functional status of adult cerebral palsy patients
Time frame: 1 year
Evaluated with mobility status ( 5 degrees )
Mental status of adult cerebral palsy patients
Time frame: 1 year
Mental status simply classified as normal/minor/moderate/severe mental retardation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Istanbul Medeniyet 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: status not confirmed, as of the sponsor's last update on 21 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bilinç Doğruöz Karatekin, MD (+905368308709, bilincdogruoz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional status of adult cerebral palsy patients (time frame: 1 year). The study lists 8 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 21 Feb 2019.