Status:
COMPLETED
COgnitive REhabilitation in Pediatric Patients with ABI, from Vegetative State to Functional Recovery
Lead Sponsor:
IRCCS Eugenio Medea
Conditions:
Acquired Brain Injury
Development, Child
Eligibility:
All Genders
3-17 years
Phase:
NA
Brief Summary
Acquired brain injuries (ABI) represent one of the most important cause of disability and mortality during the pediatric age, also in the western Countries. The important medical progress of the last ...
Detailed Description
The aims of the present study are: 1. To contribute to the adaptation of the Italian version of the Coma Recovery Scale for pediatrics, investigating behavioral responses of children across different...
Eligibility Criteria
Inclusion
- For the adaptation/validation of the Coma Recovery Scale for pediatrics for the Italian context (typically developing children, healthy volunteers)
- Inclusion Criteria:
- children aged between 0 and 5 years
- no suspicion of the presence of a neurodevelopmental disorder
- For the preliminary validation of the Coma Recovery Scale in clinical subjects:
- Inclusion criteria:
- age between 0 and 10 years at the moment of the pathological event
- LOCFAS score \<5
- a documented diagnosis of moderate-to-severe acquired brain injury of traumatic, anoxic, vascular or infective etiology (Glasgow Coma Scale, GCS\<12)
- a brain lesion reported within one year from study inclusion
- For the evaluation and comparison of the efficacy of two multidomain neuropsychological treatments (CORE-ABI vs SET-ABI) in children emerged from a disorder of consciousness:
- age between 5:0 and 17:11 years at the moment of the ABI
- LOCFAS score\>5
- time between ABI and assessment \<3 months
- GCS \<12 in the acute phase
- negative anamnesis for other developmental disorders before the ABI
Exclusion
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04499092
Start Date
October 1 2019
End Date
December 31 2023
Last Update
December 13 2024
Active Locations (1)
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1
IRCCS Eugenio Medea
Bosisio Parini, Italy, Italy, 23842