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

NCT04206475 | Completed

• 1 other identifier: Id. No.08/19_Oss
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury

Outcome Measures

Primary Outcomes (1)

• Psychometric evaluation

  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

Study Arms (2)

IM-FTP

EXPERIMENTAL

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

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

standard rehabilitation

ACTIVE COMPARATOR

physio-kinesis, occupational, speech, and neuropsychology treatments

Other: rehabilitation

Interventions

rehabilitation OTHER

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.

IM-FTP; standard rehabilitation

Intensive Memory-Focused Training Program (IM-FTP) OTHER

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

IM-FTP

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: an intensive program specific to the training and re-adaptation of memory function in children versus standard rehabilitation

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: October 21, 2013
• Primary Completion: February 3, 2018
• Study Completion: February 3, 2018
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)