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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 selec

Первичные конечные точки

• Patient-reported System Usability Scale score for StimolIrpinia [Срок оценки: Day 15, after completion of the 2-week intervention]
• Healthcare professional-reported System Usability Scale score for StimolIrpinia [Срок оценки: After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months]

Вторичные конечные точки (6)

• Patient-reported Acceptability of Intervention Measure score for StimolIrpinia [Срок оценки: Day 15, after completion of the 2-week intervention]
• Patient-reported Intervention Appropriateness Measure score for StimolIrpinia [Срок оценки: Day 15, after completion of the 2-week intervention]
• Patient-reported Feasibility of Intervention Measure score for StimolIrpinia [Срок оценки: Day 15, after completion of the 2-week intervention]
• Healthcare professional-reported Acceptability of Intervention Measure score for StimolIrpinia [Срок оценки: After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months]
• Healthcare professional-reported Intervention Appropriateness Measure score for StimolIrpinia [Срок оценки: After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months]
• Healthcare professional-reported Feasibility of Intervention Measure score for StimolIrpinia [Срок оценки: After completion of each healthcare professional's assigned StimolIrpinia sessions, up to 12 months]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Италия · 1 центр

• Polo Specialistico Riabilitativo Fondazione Don Gnocchi — Sant'Angelo dei Lombardi

Публикации

• - 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. Be

Идентификаторы

NCT: NCT07718321 · StimolIrpinia

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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