NCT03195335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

June 16, 2017

Last Update Submit

August 25, 2018

Conditions

Keywords

Cerebral PalsyParticipationLIFE Habits (life-H)ValidityReliability

Outcome Measures

Primary Outcomes (1)

  • Life Habits Questionnaire (LIFE-H)

    Assessing of the participation level of children

    At baseline

Secondary Outcomes (2)

  • Gross Motor Function Classification System (GMFCS)

    At baseline

  • Pediatric Outcomes Date Collection (PODCI) (Questionnaire)

    At baseline

Study Arms (1)

Children with cerebral palsy

Children who diagnosed as cerebral palsy by a pediatric neurologist

Other: Assessment via questionnaire

Interventions

All the children will be assessed via assessment questionnaires.

Children with cerebral palsy

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • To be diagnosed as cerebral palsy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

  • Noreau, Luc, Patrick Fougeyrollas, and Claude Vincent.

    BACKGROUND
  • Damiano, Diane L., Marc D. Gilgannon, and Mark F. Abel.

    BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mintaze KEREM GÜNEL

    Prof. Dr.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Doc. Dr.

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 22, 2017

Study Start

August 1, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations