An interventional study of rehabilitation and Intensive Memory-Focused Training Program (IM-FTP) in Acquired Brain Injury, sponsored by IRCCS Eugenio Medea. Completed at 1 site in Italy. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-02-06.
Sponsored by IRCCS Eugenio Medea · Not applicable, Interventional, and Treatment
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.
2,125 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
This study's enrollment of 21 is below the median of 48 across 1,341 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →IRCCS Eugenio Medea is the lead sponsor of 108 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
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)
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.
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
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)
Time frame: 4 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2013 to primary completion in Feb 2018, 51 months.
Of 566 non-industry interventional studies with no phase under Brain Injuries, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 52. This study's 51 months is above that.
Counting every sponsor, half of 599 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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