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.
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.
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.
Single group
StimolIrpinia-supported cognitive rehabilitation activities
BehavioralStimolIrpinia is a multimedia repository of autobiographical and territorially relevant stimuli from the Irpinia area, including images, videos, iconographic materials, cultural information, local landmarks, traditional foods, and links to virtual exploration tools. The repository is not a medical device and does not provide autonomous therapeutic, diagnostic, or decision-support functions. Patients will receive six 30-minute sessions over two weeks. During each session, the operator will select multimedia materials and exercises according to the patient's life experiences, familiarity with the Irpinia area, and cognitive profile. Activities may include memory exercises, language exercises, spatial orientation tasks, autobiographical memory stimulation, recognition tasks, and gnosic activities. All patients will continue their routine comprehensive rehabilitation program.
Patient-reported System Usability Scale score for StimolIrpinia
Usability of StimolIrpinia from the patient perspective will be assessed using the System Usability Scale. The System Usability Scale total score ranges from 0 to 100, with higher scores indicating greater perceived usability.
Healthcare professional-reported System Usability Scale score for StimolIrpinia
Usability of StimolIrpinia from the healthcare professional perspective will be assessed using the System Usability Scale. The System Usability Scale total score ranges from 0 to 100, with higher scores indicating greater perceived usability.
Patient-reported Acceptability of Intervention Measure score for StimolIrpinia
Acceptability of StimolIrpinia from the patient perspective will be assessed using the Acceptability of Intervention Measure. The measure includes 4 items rated on a 5-point Likert scale. The mean score ranges from 1 to 5, with higher scores indicating greater perceived acceptability.
Patient-reported Intervention Appropriateness Measure score for StimolIrpinia
Perceived appropriateness of StimolIrpinia from the patient perspective will be assessed using the Intervention Appropriateness Measure. The measure includes 4 items rated on a 5-point Likert scale. The mean score ranges from 1 to 5, with higher scores indicating greater perceived appropriateness.
Patient-reported Feasibility of Intervention Measure score for StimolIrpinia
Perceived feasibility of StimolIrpinia from the patient perspective will be assessed using the Feasibility of Intervention Measure. The measure includes 4 items rated on a 5-point Likert scale. The mean score ranges from 1 to 5, with higher scores indicating greater perceived feasibility.
Healthcare professional-reported Acceptability of Intervention Measure score for StimolIrpinia
Acceptability of StimolIrpinia from the healthcare professional perspective will be assessed using the Acceptability of Intervention Measure. The measure includes 4 items rated on a 5-point Likert scale. The mean score ranges from 1 to 5, with higher scores indicating greater perceived acceptability.
Number of completed StimolIrpinia sessions
Adherence to the StimolIrpinia-supported rehabilitation sessions will be assessed as the number of completed sessions out of the 6 planned sessions. The score ranges from 0 to 6, with higher values indicating greater adherence.
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Alfonso Magliacano
Lead sponsor
Fondazione Don Carlo Gnocchi ETS
Sponsor institution
