Participation to Life of Children With Cerebral Palsy (PLCC)

August 25, 2018 updated by: Mintaze Kerem Gunel, Hacettepe University

The Investigation of Necessity, Participation to Life of Children With Cerebral Palsy and Their Families

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.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 the past, the impairment seen in child was concentrated and child was the passive receptor of treatment. Today, this view is changed and child is the active participant of the treatment of disability. The aim of treatment is identified as increasing the quality of life by supporting the activity and participation according to the priorities of the child and the parent.

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. Moreover, the results of this study will be shared with the Ministry of National Education, the Ministry of Family and Social Policies, and the Ministry of Health and this will bring a different viewpoint to the community-based rehabilitation services in Turkey. Furthermore, this study will be expected to motivate countrywide investigations.

In the project, Gross Motor Function Classification System (GMFCS) for the severity of the disability of people with CP, The Measure of Processes of Care (MPOC) for their care process, the Pediatric Outcomes Date Collection (PODCI) Instrument and Pediatric Quality of Life Questionnaire and The Child Health Quality (CHQ PF-50) for their health-related quality of life, the Manual Ability Classification System (MACS) for the manual abilities and the Communication Function Classification System (CFCS) for the communication skill and the Life Habits Questionnaire (LIFE-H) for the participation level and Impact on Family Scale (IPFAM) for family impact will be used and the outcomes will be analyzed by adequate statistical methods. It is intended to be discussed the findings of the project in national and international platforms.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Hacettepe University
        • Contact:
          • Mintaze Kerem Günel

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 18 years (Child, Adult)

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Life Habits Questionnaire (LIFE-H)
Time Frame: At baseline
Assessing of the participation level of children
At baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gross Motor Function Classification System (GMFCS)
Time Frame: At baseline
Assessing severity of the disability of children
At baseline
Pediatric Outcomes Date Collection (PODCI) (Questionnaire)
Time Frame: At baseline
Assessing health-related quality of life of children by parent proxy questionnaire
At baseline
Manual Ability Classification System (MACS)
Time Frame: At baseline
Assessing the manual abilities
At baseline
Communication Function Classification System (CFCS)
Time Frame: At baseline
Assessing communication skill
At baseline
The Child Health Quality (CHQ PF-50)
Time Frame: At baseline
Assessing health-related quality of life
At baseline
Pediatric Quality of Life Questionnaire (PedsQL)
Time Frame: At baseline
Assessing health-related quality of life
At baseline
The Measure of Processes of Care (MPOC) (Questionnaire)
Time Frame: At baseline
Assessing health care process of children by parent proxy questionnaire
At baseline
Impact on Family Scale (IPFAM)
Time Frame: At baseline
Assessing family impact
At baseline
Pediatric Evaluation of Disability Inventory
Time Frame: At baseline
Assessing disability
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey
Cumhuriyet University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 116S359-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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