Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired br.Inj.

IRCCS Eugenio Medea

Status: Completed

Conditions: Acquired Brain Injury

Treatments: Other: Intensive Memory-Focused Training Program (IM-FTP); Other: rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04206475

Id. No.08/19_Oss

Details and patient eligibility

About

Memory deficits are common sequelae of pediatric Acquired Brain Injury (ABI). Only methods for non-focused cognitive remediation are available to the pediatric field. The aims of this feasibility trial are the description, implementation, and test of an intensive program specific to the training and re-adaptation of memory function in children (IM-FTP). Method: Eleven children and adolescents with ABI (mean age at injury=12.2 years, brain tumor survivors excluded) were clinically assessed and rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments. Each patient received a psychometric evaluation and a brain functional MRI at enrollment and at discharge. Ten pediatric controls with ABI (mean age at injury=13.8 years) were clinically assessed, and rehabilitated through a standard program.

Enrollment: 21 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• i) age at first assessment between 6 and 18 years;
• ii) time between injury and first assessment <3 months;
• iii) documented evidence of a severe ABI of traumatic or non-traumatic (i.e. anoxic, vascular or infectious) etiology, as indicated by a Glasgow Coma Scale (GCS, [26]), score ≤8 at insult;
• iv) presence of severe memory impairment, as assessed at first evaluation;
• v) sufficient attentive skills for attending a simple task and understanding simple commands/directions, and sufficient verbal comprehension for executing simple procedures/exercises;
• vi) absence of congenital pathology or disability previous to the injury;
• vii) medical records sufficiently detailed to determine the injury severity and neurological findings;
• viii) absence of severe motor or sensitive deficits.

Exclusion criteria

• none

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

IM-FTP

Experimental group

Description:

rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments

Treatment:

Other: Intensive Memory-Focused Training Program (IM-FTP)

Other: rehabilitation

standard rehabilitation

Active Comparator group

Description:

physio-kinesis, occupational, speech, and neuropsychology treatments

Treatment:

Other: rehabilitation