Back to resultsFeasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired br.Inj.
Primary Purpose
Acquired Brain Injury
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
rehabilitation
Intensive Memory-Focused Training Program (IM-FTP)
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Brain Injury
Eligibility Criteria
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
Sites / Locations
- IRCCS E. Medea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IM-FTP
standard rehabilitation
Arm Description
rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments
physio-kinesis, occupational, speech, and neuropsychology treatments
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04206475
First Posted
December 18, 2019
Last Updated
February 4, 2020
Sponsor
IRCCS Eugenio Medea
1. Study Identification
Unique Protocol Identification Number
NCT04206475
Brief Title
Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired br.Inj.
Official Title
Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired Brain Injury.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 21, 2013 (Actual)
Primary Completion Date
February 3, 2018 (Actual)
Study Completion Date
February 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
an intensive program specific to the training and re-adaptation of memory function in children versus standard rehabilitation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IM-FTP
Arm Type
Experimental
Arm Description
rehabilitated over 1-month through IM-FTP, including physio-kinesis/occupational, speech, and neuropsychology treatments
Arm Title
standard rehabilitation
Arm Type
Active Comparator
Arm Description
physio-kinesis, occupational, speech, and neuropsychology treatments
Intervention Type
Other
Intervention Name(s)
rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Intensive Memory-Focused Training Program (IM-FTP)
Intervention Description
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
Primary Outcome Measure Information:
Title
Psychometric evaluation
Description
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)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
IRCCS E. Medea
City
Bosisio Parini
State/Province
Lecco
ZIP/Postal Code
23842
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility Randomized Trial for an Intensive Memory-Focused Training Program for School Aged Children With Acquired br.Inj.
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