Turkish Version of LIFE Habits Assessment | NCT03195335

Studies
Turkish Version of LIFE Habits Assessment

NCT03195335

Sponsor

Hacettepe University

Status

Completed

Last Update Posted

Aug 28, 2018Actual

Enrollment

98Actual

Phase

Not provided

Conditions

Cerebral Palsy

Interventions

Assessment via questionnaire

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2017Actual

Primary Completion Date

Aug 1, 2018Actual

Completion Date

Aug 1, 2018Actual

First Submitted Date

Jun 16, 2017

First Submission Date that Met QC Criteria

Jun 21, 2017

First Posted Date

Jun 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2018

Last Update Posted Date

Aug 28, 2018Actual

Name	Class
Cumhuriyet University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children with cerebral palsy		Children who diagnosed as cerebral palsy by a pediatric neurologist	Other: Assessment via questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Assessment via questionnaire	Other	All the children will be assessed via assessment questionnaires.	Children with cerebral palsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Life Habits Questionnaire (LIFE-H)	Assessing of the participation level of children	At baseline

Secondary Outcomes

Measure	Description	Time Frame
Gross Motor Function Classification System (GMFCS)	Assessing severity of the disability of children	At baseline
Pediatric Outcomes Date Collection (PODCI) (Questionnaire)	Assessing health-related quality of life of children by parent proxy questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

To be diagnosed as cerebral palsy

Exclusion Criteria:

Children whose family didn't accept to participate to study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

The subjects will be recruited from children who lives in Ankara city and, attend special education centers.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mintaze KEREM GÜNEL	Prof. Dr.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hacettepe University		Ankara			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Noreau, Luc, Patrick Fougeyrollas, and Claude Vincent.
	Background	Damiano, Diane L., Marc D. Gilgannon, and Mark F. Abel.

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases