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

NCT07718321 | Recruiting

• 1 other identifier: StimolIrpinia
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Acquired Brain Injury; Cognitive Rehabilitation; Neurorehabilitation; Cognitive Impairment

Keywords

severe acquired brain injury; cognitive rehabilitation; ecological rehabiliation; autobiographical stimuli; multimedia repository; acceptability; usability; feasibility; irpinia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Patient-reported Acceptability of Intervention Measure score for StimolIrpinia

  Day 15, after completion of the 2-week intervention

• Patient-reported Intervention Appropriateness Measure score for StimolIrpinia

  Day 15, after completion of the 2-week intervention

• Patient-reported Feasibility of Intervention Measure score for StimolIrpinia

  Day 15, after completion of the 2-week intervention

• Healthcare professional-reported Acceptability of Intervention Measure score for StimolIrpinia

  After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months

• Healthcare professional-reported Intervention Appropriateness Measure score for StimolIrpinia

  After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months

Other Outcomes (1)

• Number of completed StimolIrpinia sessions

  From Day 1 to Day 15

Study Arms (1)

Patients receiving StimolIrpinia-supported cognitive rehabilitation

EXPERIMENTAL

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

Interventions

StimolIrpinia-supported cognitive rehabilitation activities BEHAVIORAL

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.

Patients receiving StimolIrpinia-supported cognitive rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participation in the development of the StimolIrpinia repository, resulting in prior familiarity with the repository.

Sponsors & Collaborators

• Alfonso Magliacano: lead

Study Sites (1)

Polo Specialistico Riabilitativo Fondazione Don Gnocchi

Sant'Angelo dei Lombardi, AV, 83054, Italy

RECRUITING

Related Publications (1)

• - 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

  BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Alfonso Magliacano

CONTACT

393387389414; amagliacano@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher, Psychologist, PhD

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 21, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): August 22, 2027
• Study Completion (Estimated): August 22, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)