Feasibility and Acceptability of StimolIrpinia for Cognitive Rehabilitation After Severe Acquired Brain Injury (StimolIrpinia)

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Cognitive Rehabilitation; Neurorehabilitation; Severe Acquired Brain Injury
• Intervention / Treatment: Behavioral: StimolIrpinia-supported cognitive rehabilitation activities

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alfonso Magliacano; Phone Number: 393387389414; Email: amagliacano@dongnocchi.it

Study Locations

• Italy
  • AV
    • Sant'Angelo dei Lombardi, AV, Italy, 83054
      • Recruiting
      • Polo Specialistico Riabilitativo Fondazione Don Gnocchi
      • Sub-Investigator: Anna Estraneo
      • Contact: Alfonso Magliacano; Phone Number: 3387389414; Email: amagliacano@dongnocchi.it
      • Contact: Email: amagliacano@dongnocchi.it
      • Principal Investigator: Alfonso Magliacano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients receiving StimolIrpinia-supported cognitive rehabilitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Day 1 to Day 15

Collaborators and Investigators

• Sponsor: Alfonso Magliacano

Publications and helpful links

General Publications

• - De Luca, R., Maggio, M. G., Naro, A., Portaro, S., Cannavò, A., & Calabrò, R. S. (2020). Can patients with severe traumatic brain injury be trained with cognitive telerehabilitation? An inpatient feasibility and usability study. Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia, 79, 246-250. https://doi.org/10.1016/j.jocn.2020.07.063 - Faulkner L. Beyond the five-user assumption: Benefits of increased sample sizes in usability testing. Behav Res Methods Instrum Comput. 2003;35(3):379-383. doi:10.3758/BF03195514 - Hwang W, Salvendy G. Number of people required for usability evaluation: The 10 ± 2 rule. Commun ACM. 2010;53(5):130-133. doi:10.1145/1735223.1735255 - Kunselman AR. Pilot studies and feasibility studies in clinical research. J Biopharm Stat. 2024;34(1):1-12. - Magliacano, A., Fiorentino, M. R., Scarano, G., Colella, M., Fasano, C., Spinola, M., Monda, A., Estraneo, A., & VR-sABI study group (2025). Non-immersive virtual reality for cognitive rehabilitation of individuals with severe acquired brain injury (VR-sABI): study protocol for a multicentric randomized controlled trial. Trials, 26(1), 392. https://doi.org/10.1186/s13063-025-09128-7 - Ponsford J, Sloan S, Snow P. Traumatic brain injury: Rehabilitation for everyday adaptive living. 2nd ed. New York: Psychology Press; 2013. - Wilson BA. Memory rehabilitation: Integrating theory and practice. New York: Guilford Press; 2009. - Woods B, Spector AE, Jones CA, Orrell M, Davies SP. Reminiscence therapy for dementia. Cochrane Database Syst Rev. 2005;(2):CD001120. doi:10.1002/14651858.CD001120.pub2

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2026
• Primary Completion (Estimated): August 22, 2027
• Study Completion (Estimated): August 22, 2027

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: feasibility; cognitive rehabilitation; acceptability; usability; severe acquired brain injury; ecological rehabiliation; autobiographical stimuli; multimedia repository; irpinia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Neurocognitive Disorders; Cognition Disorders; Craniocerebral Trauma; Trauma, Nervous System; Cognitive Dysfunction; Brain Injuries
• Other Study ID Numbers: StimolIrpinia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No