StimolIrpiniaStimolIrpinia for Cognitive Rehabilitation in Severe Acquired Brain Injury
This study aims to assess the usability of StimolIrpinia, a tool for cognitive rehabilitation in severe acquired brain injury, from both the patient and healthcare professional perspectives using the System Usability Scale.
StimolIrpinia-supported cognitive rehabilitation activities
Mental Disorders+8
+ Brain Diseases
+ Central Nervous System Diseases
Services Research Study
Summary
Study start date: June 22, 2026
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Services Research Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Patients With Severe Acquired Brain Injury - Inclusion Criteria * Age between 18 and 75 years. * 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. * Having lived for a prolonged period in the Irpinia area, including Partenio, Valle Ufita-Baronia, Serinese-Solofrana, Alta Irpinia, Vallo di Lauro-Baianese, and/or Terminio-Cervialto. * Written informed consent signed by the patient or by the patient's legal representative. 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 * 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. Rehabilitation Professionals/Operators - Exclusion Criteria • Participation in the development of the StimolIrpinia repository, resulting in prior familiarity with the repository.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Polo Specialistico Riabilitativo Fondazione Don Gnocchi
Sant'Angelo dei Lombardi, ItalyOpen Polo Specialistico Riabilitativo Fondazione Don Gnocchi in Google Maps