Cerebral PalsyTVoLHANCT03195335
Turkish Version of LIFE Habits Assessment
An observational study of Cerebral Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral Palsy (CP) is the most common cause of physical disability in children, is a non-progressive neurological impairment resulting from an injury in the developing brain and causing various problems related to sensory, perception, cognition, and movement. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Assessment via questionnaire
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2017to 1 Aug 2018
- How long will I take part?
- 1 Week
- 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: The subjects will be recruited from children who lives in Ankara city and, attend special education centers.
Who may be able to join
- To be diagnosed as cerebral palsy
Who cannot join
- Children whose family didn't accept to participate to study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability of Turkish Version of LIFE Habits (Life-H) Assessment for Children With Cerebral Palsy
Cerebral Palsy (CP) is the most common cause of physical disability in children, is a non-progressive neurological impairment resulting from an injury in the developing brain and causing various problems related to sensory, perception, cognition, and movement. This problems leads activity and participation levels of the children with CP. In the literature various assessment tools developed for assessing participation. Assessment of Life Habits (LIFE-H) questionnaire is one of the assessment tools that examines activities of daily life and participation in detail. The scale is originally in French but English and German versions are also available. The aim of this study is to translate the scale to Turkish and to determine validity and reliability of Turkish version of Life Habits questionnaire.
- Conditions
- Cerebral Palsy
- Being tested
- Assessment via questionnaire
- Keywords
- Cerebral Palsy, Participation, LIFE Habits (life-H), Validity, Reliability
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment via questionnaireOther
All the children will be assessed via assessment questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Children with cerebral palsy | Children who diagnosed as cerebral palsy by a pediatric neurologist Receives: Other: Assessment via questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life Habits Questionnaire (LIFE-H)
Assessing of the participation level of children
Measured: At baseline
Secondary outcomes (2)
Gross Motor Function Classification System (GMFCS)
Assessing severity of the disability of children
Measured: At baseline
Pediatric Outcomes Date Collection (PODCI) (Questionnaire)
Assessing health-related quality of life of children by parent proxy questionnaire
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 posted22 Jun 2017
- Study start1 Aug 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Cumhuriyet University
- Responsible party
- Principal investigator, Mintaze Kerem Gunel, Hacettepe University
- Investigators
- Mintaze KEREM GÜNEL, Principal investigator, Prof. Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195335
- Sponsor's protocol ID
- 116S359
- Acronym
- TVoLHA
- Status last verified
- Aug 2018
- First submitted
- 16 Jun 2017
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Noreau, Luc, Patrick Fougeyrollas, and Claude Vincent.
Damiano, Diane L., Marc D. Gilgannon, and Mark F. Abel.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Turkish Version of LIFE Habits (Life-H) Assessment for Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03195335
- Acronym / sponsor ID
- TVoLHA / 116S359
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Participation, LIFE Habits (life-H), Validity, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Cumhuriyet University
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 22 Jun 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.
Cerebral Palsy (CP) is the most common cause of physical disability in children, is a non-progressive neurological impairment resulting from an injury in the developing brain and causing various problems related to sensory, perception, cognition, and movement. This problems leads activity and participation levels of the children with CP. In the literature various assessment tools developed for assessing participation. Assessment of Life Habits (LIFE-H) questionnaire is one of the assessment tools that examines activities of daily life and participation in detail. The scale is originally in French but English and German versions are also available. The aim of this study is to translate the scale to Turkish and to determine validity and reliability of Turkish version of Life Habits questionnaire.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy | – | Other: Assessment via questionnaireChildren who diagnosed as cerebral palsy by a pediatric neurologist |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The subjects will be recruited from children who lives in Ankara city and, attend special education centers.
Key inclusion criteria (1 listed)
- To be diagnosed as cerebral palsy
Key exclusion criteria (1 listed)
- Children whose family didn't accept to participate to 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 |
|---|---|---|
| Assessment via questionnaireAll the children will be assessed via assessment questionnaires. | Other | Children with cerebral palsy |
Primary outcome
Life Habits Questionnaire (LIFE-H)
Time frame: At baseline
Assessing of the participation level of children
2 secondary outcomes
Gross Motor Function Classification System (GMFCS)
Time frame: At baseline
Pediatric Outcomes Date Collection (PODCI) (Questionnaire)
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 28 Aug 2018.
- BackgroundNoreau, Luc, Patrick Fougeyrollas, and Claude Vincent.
- BackgroundDamiano, Diane L., Marc D. Gilgannon, and Mark F. Abel.
- 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.
Mintaze KEREM GÜNEL principal investigator
Prof. Dr.
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 1 inclusion and 1 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 28 Aug 2018. 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?
Life Habits Questionnaire (LIFE-H) (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03195335, which also lists 2 linked publications.
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 28 Aug 2018.