Cerebral PalsyVERSIONNCT03130075
Reliability and Validity of the Turkish Version of Caregiver Functional Use Survey (CFUS)
An observational study of Cerebral Palsy, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Increasing the number of Turkish version of the questionnaire evaluating hand use, adding the scales that evaluate the selective movements of the upper limb to the evaluations will increase the variety of evaluation methods. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2017to 25 Aug 2017
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with Hemiplegia Cerebral Palsy
Who may be able to join
- Ages between 3-15 years
- Diagnosed as Cerebral Palsy (Hemiplegia)
- Literate in Turkish language and can complete the questionnaire by primer caregiver
Who cannot join
- Cannot understand the questionnaire by themselves.
- Participants had a botulinum toxin injection within the last 6 months
- Any surgical correction within the last year
Trial locations and contacts
1 site in 1 country.
About this study
Increasing the number of Turkish version of the questionnaire evaluating hand use, adding the scales that evaluate the selective movements of the upper limb to the evaluations will increase the variety of evaluation methods.
The purpose of this study is to evaluate the validity and reliability of the Turkish version of the Caregiver Functional Use Survey (CFUS)
Read the detailed description
CFUS was designed to assess caregivers' perceptions of how much and how well their child used the involved upper extremity.
Children's upper extremity functions will be assessed with a Jebsen Taylor Hand Function Test. Their family will be asked to fill the CFUS.
Compare the relationship between Jebsen-Taylor Hand Function Test and Turkish Version CFUS. Investigate the internal consistency of Turkish-version of CFUS by using Cronbach's alpha coefficient.
- Conditions
- Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of Caregiver Functional Use Survey (CFUS)
Compare the relationship between Jebsen-Taylor Hand Function Test and Turkish Version CFUS
Measured: 8 week
Secondary outcomes (1)
Reliability of CFUS
Investigate the internal consistency of Turkish-version of CFUS by using Cronbach's alpha coefficient.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start2 May 2017
- Primary completion25 Jul 2017 (estimated)
- Study completion25 Aug 2017 (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 Gazi 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan Yildiz, Gazi University
- Investigators
- Bülent Elbasan, Study chair, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130075
- Sponsor's protocol ID
- E.150100
- Acronym
- VERSION
- Status last verified
- May 2017
- First submitted
- 21 Apr 2017
- Last updated
- 30 May 2017
- 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 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Version of Caregiver Functional Use Survey (CFUS)
- ClinicalTrials.gov ID
- NCT03130075
- Acronym / sponsor ID
- VERSION / E.150100
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 25 Jul 2017 (estimated)
- Study completion
- 25 Aug 2017 (estimated)
- First posted
- 26 Apr 2017 (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.
Increasing the number of Turkish version of the questionnaire evaluating hand use, adding the scales that evaluate the selective movements of the upper limb to the evaluations will increase the variety of evaluation methods.
The purpose of this study is to evaluate the validity and reliability of the Turkish version of the Caregiver Functional Use Survey (CFUS)
Detailed description
CFUS was designed to assess caregivers' perceptions of how much and how well their child used the involved upper extremity.
Children's upper extremity functions will be assessed with a Jebsen Taylor Hand Function Test. Their family will be asked to fill the CFUS.
Compare the relationship between Jebsen-Taylor Hand Function Test and Turkish Version CFUS. Investigate the internal consistency of Turkish-version of CFUS by using Cronbach's alpha coefficient.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with Hemiplegia Cerebral Palsy
Key inclusion criteria (3 listed)
- Ages between 3-15 years
- Diagnosed as Cerebral Palsy (Hemiplegia)
- Literate in Turkish language and can complete the questionnaire by primer caregiver
Key exclusion criteria (3 listed)
- Cannot understand the questionnaire by themselves.
- Participants had a botulinum toxin injection within the last 6 months
- Any surgical correction within the last year
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
Validity of Caregiver Functional Use Survey (CFUS)
Time frame: 8 week
Compare the relationship between Jebsen-Taylor Hand Function Test and Turkish Version CFUS
1 secondary outcome
Reliability of CFUS
Time frame: 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- 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.
Bülent Elbasan study chair
Study chair
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 Gazi 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: status not confirmed, as of the sponsor's last update on 30 May 2017. 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?
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?
Validity of Caregiver Functional Use Survey (CFUS) (time frame: 8 week). 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 30 May 2017.