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

Not Applicable

Completed

• Conditions: Acquired Brain Injury
• Interventions: Other: rehabilitation; Other: Intensive Memory-Focused Training Program (IM-FTP)

• Registration Number: NCT04206475
• Lead Sponsor: IRCCS Eugenio Medea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-21
• Primary Completion: 2018-02-03
• Study Completion: 2018-02-03
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-18
• Study First Posted: 2019-12-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard rehabilitation	rehabilitation	physio-kinesis, occupational, speech, and neuropsychology treatments
IM-FTP	rehabilitation	rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments
IM-FTP	Intensive Memory-Focused Training Program (IM-FTP)	rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments

Primary Outcome Measures

Name	Time	Method
Psychometric evaluation	4 weeks	At both time points, the patients were administered the Rey- Osterrieth complex figure test (REY), the test for immediate and delayed memory of a list of words of the Italian 'Batteria di Valutazione Neuropsicologica' (BVN) battery (BVNLi and BVNLd, respectively), the test for immediate and delayed recall in prose memory of the Italian BVN battery (BVNPi and BVNPd), the test for immediate and delayed recall in positional memory supra-span (SUPRASPANi and SUPRASPANd), and the Italian TEMA test for the learning of couples of related and unrelated words (TEMA)

Trial Locations

Locations (1)

IRCCS E. Medea; 🇮🇹 Bosisio Parini, Lecco, Italy