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Participation to Life of Children With Cerebral Palsy (PLCC)

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ClinicalTrials.gov Identifier: NCT03191695
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : August 28, 2018
Sponsor:
Collaborators:
The Scientific and Technological Research Council of Turkey
Cumhuriyet University
Information provided by (Responsible Party):
Mintaze Kerem Gunel, Hacettepe University

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.

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

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: The Investigation of Necessity, Participation to Life of Children With Cerebral Palsy and Their Families
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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

  3. Manual Ability Classification System (MACS) [ Time Frame: At baseline ]
    Assessing the manual abilities

  4. Communication Function Classification System (CFCS) [ Time Frame: At baseline ]
    Assessing communication skill

  5. The Child Health Quality (CHQ PF-50) [ Time Frame: At baseline ]
    Assessing health-related quality of life

  6. Pediatric Quality of Life Questionnaire (PedsQL) [ Time Frame: At baseline ]
    Assessing health-related quality of life

  7. The Measure of Processes of Care (MPOC) (Questionnaire) [ Time Frame: At baseline ]
    Assessing health care process of children by parent proxy questionnaire

  8. Impact on Family Scale (IPFAM) [ Time Frame: At baseline ]
    Assessing family impact

  9. Pediatric Evaluation of Disability Inventory [ Time Frame: At baseline ]
    Assessing disability



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): NCT03191695


Contacts
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Contact: Mintaze KEREM GÜNEL +905327164221 mintaze@yahoo.com
Contact: Ayşe Numanoğlu Akbaş +905058644036 aysenumanoglu@gmail.com

Locations
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Turkey
Hacettepe University Recruiting
Ankara, Turkey
Contact: Mintaze Kerem Günel         
Sponsors and Collaborators
Hacettepe University
The Scientific and Technological Research Council of Turkey
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. Dr., Hacettepe University
ClinicalTrials.gov Identifier: NCT03191695    
Other Study ID Numbers: 116S359-1
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Participation
Activity
Cerebral Palsy
LIFE Habits (life-H)
Gross Motor Function
Health-related Quality of Life
Family
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases