About this trial
This single-center pilot study evaluates the feasibility, acceptability, usability, and preliminary stimulus validation of StimolIrpinia, a multimedia repository of culturally and territorially relevant autobiographical stimuli designed to support cognitive rehabilitation activities in patients with severe acquired brain injury (sABI). The repository includes images, videos, maps, local cultural information, and printable materials related to the Irpinia area in Campania, Italy. Healthy adult volunteers will review the stimuli for their ability to evoke autobiographical memories, familiarity, emotional activation, and pleasantness. Hospitalized patients with sABI will complete six 30-minute StimolIrpinia-supported rehabilitation sessions over two weeks in addition to their routine comprehensive rehabilitation program. Rehabilitation professionals will receive standardized training and will use the repository to personalize cognitive rehabilitation exercises. Usability and acceptability will be evaluated from both patient and operator perspectives.
Eligibility criteria
Qualifiers
Level of Cognitive Functioning (LCF) score >= 5 at study entry.
Stable clinical diagnosis, assessed by at least four repeated LCF evaluations within a 1-week time window.
History of severe acquired brain injury of traumatic, anoxic, vascular, or mixed etiology, defined as Glasgow Coma Scale score <= 8 for at least 24 hours after brain injury.
Pathological performance on at least one Oxford Cognitive Screening (OCS) subscale.
Disqualifiers
Age >= 18 years.
Proven experience in neuromotor and/or cognitive rehabilitation of patients with severe acquired brain injury.
Written informed consent to participate in the study.
Trial design
Treatments tested in this trial
- StimolIrpinia-supported cognitive rehabilitation activities
Treatment groups
Sponsors and collaborators
Alfonso Magliacano
Lead sponsor
Fondazione Don Carlo Gnocchi ETS
Sponsor institution