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

February 4, 2020 updated by: IRCCS Eugenio Medea

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lecco
      • Bosisio Parini, Lecco, Italy, 23842
        • IRCCS E. Medea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IM-FTP
rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments
Other: rehabilitation

the rehabilitation program consisted of an intensive treatment lasting 4 weeks, and including 3 daily interventions each working day (5 working days per week, for a total of 20 days of treatment and 60 sessions). The 3 daily sessions were organized as follows:

1 physio-kinesis and/or occupational therapy, 1 speech therapy, and 1 neuro-psychology treatment.

Each session lasted 45 minutes.

Other: Intensive Memory-Focused Training Program (IM-FTP)
During each session, the patient was engaged in a one-to-one interaction with the therapist. Overall, the treatment targeted the following memory subfunctions: verbal and visuo-spatial short-term memory, verbal and visuo-spatial long-term memory, working memory and procedural memory
ACTIVE_COMPARATOR: standard rehabilitation
physio-kinesis, occupational, speech, and neuropsychology treatments
Other: rehabilitation

the rehabilitation program consisted of an intensive treatment lasting 4 weeks, and including 3 daily interventions each working day (5 working days per week, for a total of 20 days of treatment and 60 sessions). The 3 daily sessions were organized as follows:

1 physio-kinesis and/or occupational therapy, 1 speech therapy, and 1 neuro-psychology treatment.

Each session lasted 45 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychometric evaluation
Time Frame: 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)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Eugenio Medea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 21, 2013

Primary Completion (ACTUAL)

February 3, 2018

Study Completion (ACTUAL)

February 3, 2018

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

December 18, 2019

First Posted (ACTUAL)

December 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Id. No.08/19_Oss

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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