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The Changing Panorama in Risk Factors of Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04716530
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Bilinç Doğruöz Karatekin, Istanbul Medeniyet University

Study Description
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Brief Summary:
The study will be carried of scanning the database of 296 individuals with cerebral palsy followed in the university pediatric rehabilitation clinic. Cerebral palsy risk factors and demographic information will be obtained from the database. The data will be classified according to date of birth, divided into 3 groups: those born before 2000, those born between 2000-2010, and those born after 2010.Changes in cerebral palsy risk factors will be investigated at 10-year intervals.

Condition or disease Intervention/treatment
Cerebral Palsy Other: No intervention is associated with the study.

Detailed Description:

The study will be carried of scanning the database of 296 individuals with cerebral palsy followed in the university pediatric rehabilitation clinic. Cerebral palsy risk factors and demographic information will be obtained from the database.

Cerebral palsy subtypes classified according to The Surveillance for Cerebral Palsy in Europe (SCPE) classification into four groups: spastic (unilateral and bilateral), dyskinetic (dystonic and choreoathetoic), ataxic/hypotonic, non-classifiable. Cerebral palsy risk factors will be primarily divided into 4 as preconceptional, antenatal, intrapartum and neonatal risk factors. Then, risk factors in the data will be distributed to the appropriate risk factor group.

The data will be classified according to date of birth, divided into 3 groups: those born before 2000, those born between 2000-2010, and those born after 2010. Changes in cerebral palsy risk factors will be investigated at 10-year intervals.

Study Design
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Study Type : Observational
Estimated Enrollment : 296 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Changing Panorama in Risk Factors of Cerebral Palsy: A Single National Tertiary Center Experience
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : February 20, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
born before 2000
No patient treatment is associated with the study.
 Other: No intervention is associated with the study.
No intervention is associated with the study.
born between 2000-2010
No patient treatment is associated with the study.
 Other: No intervention is associated with the study.
No intervention is associated with the study.
born after 2010
No patient treatment is associated with the study.
 Other: No intervention is associated with the study.
No intervention is associated with the study.


Outcome Measures
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Primary Outcome Measures :
  1. Define the risk factors of cerebral palsy [ Time Frame: 1 month ]
    Risk factors of cerebral palsy questioned as preconceptional, antenatal, intrapartum and neonatal.

  2. Define the change in the risk factors among age groups [ Time Frame: 1 month ]
    The difference in cerebral palsy risk factors in age groups measured by chi-square statistics (born before 2000/ born between 2000-2010/ born after 2010)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients in our cerebral palsy database
Criteria

Inclusion Criteria:

  • cerebral palsy patients

Exclusion Criteria:

  • missing data on the cerebral palsy database
Contacts and Locations
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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): NCT04716530


Locations
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Turkey
Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department Recruiting
Istanbul, Turkey, 34732
Contact: Bilinç Doğruöz Karatekin    +905368308709    bilincdogruoz@hotmail.com   
Principal Investigator: Bilinç Doğruöz Karatekin, MD         
Sub-Investigator: Afitap Icagasioglu, MD         
Sponsors and Collaborators
Istanbul Medeniyet University
More Information
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Responsible Party: Bilinç Doğruöz Karatekin, Principal Investigator, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT04716530    
Other Study ID Numbers: Istanbul MU CP
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
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 Bilinç Doğruöz Karatekin, Istanbul Medeniyet University:
cerebral palsy
etiology
risk factors
low birth weight
prematurity
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
 Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases