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Turkish Version of LIFE Habits Assessment (TVoLHA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195335
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Cumhuriyet University
Information provided by (Responsible Party):
Mintaze Kerem Gunel, Hacettepe University

Brief 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. 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.

Condition or disease Intervention/treatment
Cerebral Palsy Other: Assessment via questionnaire

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Study Type : Observational [Patient Registry]
Actual Enrollment : 98 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week
Official Title: Validity and Reliability of Turkish Version of LIFE Habits (Life-H) Assessment for Children With Cerebral Palsy
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Children with cerebral palsy
Children who diagnosed as cerebral palsy by a pediatric neurologist
Other: Assessment via questionnaire
All the children will be assessed via assessment questionnaires.




Primary Outcome Measures :
  1. Life Habits Questionnaire (LIFE-H) [ Time Frame: At baseline ]
    Assessing of the participation level of children


Secondary Outcome Measures :
  1. Gross Motor Function Classification System (GMFCS) [ Time Frame: At baseline ]
    Assessing severity of the disability of children

  2. Pediatric Outcomes Date Collection (PODCI) (Questionnaire) [ Time Frame: At baseline ]
    Assessing health-related quality of life of children by parent proxy questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects will be recruited from children who lives in Ankara city and, attend special education centers.
Criteria

Inclusion Criteria:

  • To be diagnosed as cerebral palsy

Exclusion Criteria:

  • Children whose family didn't accept to participate to study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195335


Locations
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Turkey
Hacettepe University
Ankara, Turkey
Sponsors and Collaborators
Hacettepe University
Cumhuriyet University
Investigators
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Principal Investigator: Mintaze KEREM GÜNEL Prof. Dr.

Additional Information:

Publications:
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Responsible Party: Mintaze Kerem Gunel, Prof. Doc. Dr., Hacettepe University
ClinicalTrials.gov Identifier: NCT03195335    
Other Study ID Numbers: 116S359
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mintaze Kerem Gunel, Hacettepe University:
Cerebral Palsy
Participation
LIFE Habits (life-H)
Validity
Reliability
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases