NCT03191695

Brief Summary

Cerebral Palsy (CP) defined as a group of permanent impairments that is originating from non-progressive disorders that develop in the immature brain. CP leads activity limitations of movement and posture development. Motor problems in CP are usually accompanied by sensory and perceptual disorders, cognitive disorders, communication and behavioral disorders, epilepsy, and secondary musculoskeletal system problems. The first 20 years of life is characterized by rapid growth and specific changes in physical, social, and psychological development. Social participation and independence of children and youth are related to the changes in this period. Participation can be identified as being involved in life situations and it reflects the social aspect of functionality. The problems which can be come across in life situations are identified as participation limitation. In literature, no adequate study has investigated the functional inadequacy, activity and participation of children with CP; this project has been planned in order to specify the importance in rehabilitation interventions more detailed. This project aims to specify whether the functional levels correspond to the activity and participation limitations of children with CP living in Ankara city center and determine the effects of their functional status on activity, participation and quality of life. This investigation will be pioneer in indicating the activity and participation limitations of children with CP. According to the results, these limitations will be overcome and the quality of life of children with CP will be increased. The CP follow-up database in Ankara will be specified so their physical activity and participation levels will be followed periodically and CP profile will be determined in Ankara.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
unknown

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
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

June 16, 2017

Last Update Submit

August 25, 2018

Conditions

Keywords

ParticipationActivityCerebral PalsyLIFE Habits (life-H)Gross Motor FunctionHealth-related Quality of LifeFamily

Outcome Measures

Primary Outcomes (1)

  • Life Habits Questionnaire (LIFE-H)

    Assessing of the participation level of children

    At baseline

Secondary Outcomes (9)

  • Gross Motor Function Classification System (GMFCS)

    At baseline

  • Pediatric Outcomes Date Collection (PODCI) (Questionnaire)

    At baseline

  • Manual Ability Classification System (MACS)

    At baseline

  • Communication Function Classification System (CFCS)

    At baseline

  • The Child Health Quality (CHQ PF-50)

    At baseline

  • +4 more secondary outcomes

Interventions

All the children will be assessed via assessment questionnaires.

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)

RECRUITING

Related Publications (4)

  • Himuro N, Kozuka N, Mori M. Measurement of family-centred care: translation, adaptation and validation of the Measure of Processes of Care (MPOC-56 and -20) for use in Japan. Child Care Health Dev. 2013 May;39(3):358-65. doi: 10.1111/j.1365-2214.2012.01371.x. Epub 2012 Feb 28.

    PMID: 22372945BACKGROUND
  • Bodkin AW, Robinson C, Perales FP. Reliability and validity of the gross motor function classification system for cerebral palsy. Pediatr Phys Ther. 2003 Winter;15(4):247-52. doi: 10.1097/01.PEP.0000096384.19136.02.

    PMID: 17057460BACKGROUND
  • Berg M, Jahnsen R, Froslie KF, Hussain A. Reliability of the Pediatric Evaluation of Disability Inventory (PEDI). Phys Occup Ther Pediatr. 2004;24(3):61-77. doi: 10.1300/j006v24n03_05.

    PMID: 15257969BACKGROUND
  • Damiano DL, Gilgannon MD, Abel MF. Responsiveness and uniqueness of the pediatric outcomes data collection instrument compared to the gross motor function measure for measuring orthopaedic and neurosurgical outcomes in cerebral palsy. J Pediatr Orthop. 2005 Sep-Oct;25(5):641-5. doi: 10.1097/01.bpo.0000167079.83835.22.

    PMID: 16199947BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyMotor Activity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Study Officials

  • Mintaze KEREM GÜNEL

    Prof. Dr.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mintaze KEREM GÜNEL

CONTACT

Ayşe Numanoğlu Akbaş

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 19, 2017

Study Start

February 1, 2018

Primary Completion

October 1, 2018

Study Completion

January 1, 2020

Last Updated

August 28, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations