- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03499288
Profiling Children and Youth With Cerebral Palsy in Relation to Feeding and Nutrition (Purple-N)
A Multi-country, Multi-centre, Observational, Cross-sectional Study to Evaluate Individualized Treatment and Management in Children and Adolescents With Cerebral Palsy
Study Overview
Status
Conditions
Detailed Description
Coordinating health care professionals (HCPs; e.g. paediatric neurologists, physiotherapists) in different centres across different countries will be asked to participate in this cross-sectional study.
A) for the HCP to fill out a questionnaire about their CP child, related to general subject characteristics, motor function, co-morbidities, type of therapies, anthropometry, feeding mode and nutritional status; and B) for parents (/legal representatives) to receive and fill out questionnaires about their CP child and themselves, related to general subject characteristics, motor function, co-morbidities, type of therapies, anthropometry, feeding mode and nutritional status, participation and (their own) quality of life.
If parents (/legal representatives) agree to "A)", but not "B)" then a subject will still enter the study, but without the parental assessment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Praha, Czechia
- Fakultni nemocnice v Motole
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Athens, Greece
- Attikon University General Hospital
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Budapest, Hungary
- Bethesda Children Hospital Budapest
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Bologna, Italy
- AO Sant'Orsola - Malpighi, Policlinico
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Brescia, Italy
- ASST degli Spedali Civili di Brescia
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Milano, Italy
- Fondazione IRCCS Istituto Neurologico "Carlo Besta"
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Modena, Italy
- AOU di Modena - Policlinico
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Enschede, Netherlands
- Roessingh centrum voor Revalidatie
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Gdańsk, Poland
- Medical university hospital of Gdansk
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Poznań, Poland
- Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
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Trnava, Slovakia
- Fakultna nemocnica Trnava
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Ankara, Turkey
- Ankara University School of Medicine/Neurology
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Ankara, Turkey
- Gazi University School of Medicine/Neurology
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Ankara, Turkey
- Hacettepe University School of Medicine/Neurology
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Ege, Turkey
- Ege University School of Medicine/Neurology
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Eskişehir, Turkey
- Eskisehir Osmangazi University School of Medicine/Neurology
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Marmara, Turkey
- Marmara University School of Medicine/Neurology
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Mersin, Turkey
- Mersin University School of Medicine/Neurology
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İnönü, Turkey
- Inonu University School of Medicine/Neurology
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İzmir, Turkey
- Dokuz Eylul University School of Medicine/Neurology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Confirmed diagnosis of Cerebral Palsy
- Age<18 years
- Have visited the HCP within the last year
- Written informed consent provided by parents/legal representatives according to local law
Exclusion Criteria:
- Neurodegenerative diseases
- Acute infections: meningitis, encephalitis or poliomyelitis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Children and youth with cerebral palsy
Subjects between 1 month and 18 years of age with Cerebral Palsy who visited the coordinating HCP within the past 12 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Quantify current CP characteristics 1 (general subject characteristics):
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
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Using questionnaires to quantify current CP characteristics with respect to: - General subject characteristics (e.g. Sex, Birth weight [g], Type of CP motor disorder [category] |
Data collected retrospectively, from within 12 months of entering the questionnaire
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Quantify current CP characteristics 2 (anthropometry):
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
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Using questionnaires to quantify current CP characteristics with respect to: Anthropometry: length [cm]; weight [grams] and BMI (kg/m2) |
Data collected retrospectively, from within 12 months of entering the questionnaire
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Quantify current CP characteristics 3 (motor function)
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
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Using questionnaires to quantify current CP characteristics with respect to: Motor function (GMFCS [category]; GMFM measurement type [GMFM-86/GMFM-88] |
Data collected retrospectively, from within 12 months of entering the questionnaire
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Quantify current CP characteristics 4 (comorbidities)
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
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Using questionnaires to quantify current CP characteristics with respect to: Comorbidities: epilepsy, cognitive function, GI problems [categories] |
Data collected retrospectively, from within 12 months of entering the questionnaire
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Quantify current CP characteristics 5 (therapies)
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
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Using questionnaires to quantify current CP characteristics with respect to: Type and frequency of physical/occupational therapy [type, number of hours per day /days per week] |
Data collected retrospectively, from within 12 months of entering the questionnaire
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Quantify current CP characteristics 6 (feeding mode)
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
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Using questionnaires to quantify current CP characteristics with respect to: Feeding mode and/or problems (tube feeding [yes/no], type of tube feeding etc) |
Data collected retrospectively, from within 12 months of entering the questionnaire
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Quantify current CP characteristics 7 (nutritional status)
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
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Using questionnaires to quantify current CP characteristics with respect to: Nutritional status (HCP and parent perspective on nutritional status, concerns [yes/no]) |
Data collected retrospectively, from within 12 months of entering the questionnaire
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Quality of life and participation 1
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
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Questionnaire to assess Quality of Life of subjects with CP [scores on domains]
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Data collected retrospectively, from within 12 months of entering the questionnaire
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Quality of life and participation 2
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
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Questionnaire to assess Quality of Life of parents (/legal representatives) of subjects with CP [scores on domains]
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Data collected retrospectively, from within 12 months of entering the questionnaire
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Quality of life and participation 3
Time Frame: Data collected retrospectively, from within 12 months of entering the questionnaire
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Level of participation included in the general parent questionnaire [categories]
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Data collected retrospectively, from within 12 months of entering the questionnaire
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPR15FA89628
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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