An interventional study of StimolIrpinia-supported cognitive rehabilitation activities in Severe Acquired Brain Injury, Cognitive Impairment and Cognitive Rehabilitation, sponsored by Alfonso Magliacano. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Alfonso Magliacano · Not applicable, Interventional, and Health services research
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.
Patients with severe acquired brain injury often present impairments in attention, memory, language, executive functions, visuospatial abilities, perception, reasoning, and learning. Traditional cognitive rehabilitation commonly uses standardized paper-and-pencil exercises, but the generalization of gains from abstract tasks to everyday functioning can be limited. StimolIrpinia was developed to provide ecological, culturally familiar, and emotionally meaningful material that can be flexibly integrated by rehabilitation professionals into ordinary cognitive rehabilitation activities.
StimolIrpinia is not medical software and is not a medical device under Regulation (EU) 2017/745. It is a structured repository of multimedia rehabilitation-support materials. It does not provide clinical indications, treatment protocols, decision support, automated scoring, or autonomous therapeutic functions. The materials are selected and used under the responsibility of the rehabilitation professional within routine clinical practice.
The repository contains 118 multimedia maps representing towns in the Irpinia geographic area and six macro-areas: Partenio; Valle Ufita-Baronia; Serinese-Solofrana; Alta Irpinia; Vallo di Lauro-Baianese; and Terminio-Cervialto. Each map may include historical and contemporary photographs, links for virtual territorial exploration, information on local patron saints and traditional inhabitants' nicknames, and images or recipes of typical dishes. Printable cards and a practical guide support the operator in proposing personalized cognitive activities, including cognitive estimation, memory, spatial orientation, language, autobiographical memory, orientation, recognition, and gnosic exercises.
The study has two main components. First, a stimulus-validation phase will involve healthy adults who have lived for a prolonged period in the territory represented by the repository. Second, a usability phase will involve hospitalized sABI patients and rehabilitation professionals. Patients will complete six StimolIrpinia-supported sessions over two weeks, while continuing their routine rehabilitation program. At the end of the sessions, patients and operators will complete usability and acceptability measures and will provide qualitative feedback.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's planned enrollment of 10 is below the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Alfonso Magliacano is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Patients With Severe Acquired Brain Injury - Inclusion Criteria
Patients With Severe Acquired Brain Injury - Exclusion Criteria • Severe medical conditions that may prevent participation in rehabilitation sessions, including severe language deficits incompatible with understanding instructions, severe cardiovascular instability, photosensitive or reflex epilepsy, and disabling visual or hearing deficits.
Rehabilitation Professionals/Operators - Inclusion Criteria
Rehabilitation Professionals/Operators - Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inpatients with severe acquired brain injury will receive six 30-minute sessions of cognitive rehabilitation activities supported by the StimolIrpinia multimedia repository, delivered three times per week for two weeks, in addition to routine comprehensive rehabilitation.
Behavioral: StimolIrpinia-supported cognitive rehabilitation activities
StimolIrpinia 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.
Time frame: Day 15, after completion of the 2-week intervention
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.
Time frame: After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months
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.
Time frame: Day 15, after completion of the 2-week intervention
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.
Time frame: Day 15, after completion of the 2-week intervention
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.
Time frame: Day 15, after completion of the 2-week intervention
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.
Time frame: After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months
Healthcare professional-reported Intervention Appropriateness Measure score for StimolIrpinia
Perceived appropriateness of StimolIrpinia from the healthcare professional 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.
Time frame: After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months
Healthcare professional-reported Feasibility of Intervention Measure score for StimolIrpinia
Perceived feasibility of StimolIrpinia from the healthcare professional 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.
Time frame: After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months
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.
Time frame: From Day 1 to Day 15
Plan to share: No
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Alfonso Magliacano