- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03195335
Turkish Version of LIFE Habits Assessment (TVoLHA)
August 25, 2018 updated by: Mintaze Kerem Gunel, Hacettepe University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
98
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey
- Hacettepe University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The subjects will be recruited from children who lives in Ankara city and, attend special education centers.
Description
Inclusion Criteria:
- To be diagnosed as cerebral palsy
Exclusion Criteria:
- Children whose family didn't accept to participate to study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children with cerebral palsy
Children who diagnosed as cerebral palsy by a pediatric neurologist
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All the children will be assessed via assessment questionnaires.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Life Habits Questionnaire (LIFE-H)
Time Frame: At baseline
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Assessing of the participation level of children
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At baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gross Motor Function Classification System (GMFCS)
Time Frame: At baseline
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Assessing severity of the disability of children
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At baseline
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Pediatric Outcomes Date Collection (PODCI) (Questionnaire)
Time Frame: At baseline
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Assessing health-related quality of life of children by parent proxy questionnaire
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At baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Noreau, Luc, Patrick Fougeyrollas, and Claude Vincent.
- Damiano, Diane L., Marc D. Gilgannon, and Mark F. Abel.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2017
Primary Completion (ACTUAL)
August 1, 2018
Study Completion (ACTUAL)
August 1, 2018
Study Registration Dates
First Submitted
June 16, 2017
First Submitted That Met QC Criteria
June 21, 2017
First Posted (ACTUAL)
June 22, 2017
Study Record Updates
Last Update Posted (ACTUAL)
August 28, 2018
Last Update Submitted That Met QC Criteria
August 25, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 116S359
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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