The goal of this clinical trial is to assess the usability and feasibility of a robotic and virtual reality-based system called NeglectARm 3D for the three-dimensional assessment of unilateral spatial neglect (USN) in patients with brain injury due to ischemic or hemorrhagic stroke.
The main questions it aims to answer are:
* Is the NeglectARm 3D system usable and feasible for patients with USN? * Do the robotic measurements show preliminary reliability and validity compared with conventional clinical neglect assessments (e.g., BIT, CBS)?
Participants will:
* Perform two assessment sessions, three weeks apart (T0 and T1); * Interact with the NeglectARm 3D system using a robotic end-effector and a VR headset to reach sequentially presented targets in a 3D virtual space; * Receive robotic assistance if targets are not reached, allowing the system to record trajectories, spatial positions, and assistance applied; * Complete standard clinical neglect tests to enable comparison between robotic and conventional measures.
This study aims to develop a repeatable, standardized, and objective tool for the assessment of USN in patients with brain injury, potentially improving evaluation of depth perception and spatial attention deficits.
Age > 18 years;
Diagnosis of ischemic or hemorrhagic stroke;
Diagnosis of Unilateral Spatial Neglect (assessed by The Hearts Test, Oxford Cognitive Screen, cut-off ± 2);
Signed informed consent form.
Presence of language deficits (inability to complete the OCS test);
Presence of cognitive decline prior to the stroke event;
Presence of severe visual and/or hearing impairments;
Language barriers;
The enrollment phase will be conducted at the IRCCS Fondazione Don Carlo Gnocchi in Florence (FI) and at the Fondazione Don Carlo Gnocchi in Sant'Angelo dei Lombardi (AV), in Italy. Each patient will be considered enrolled after assessment of inclusion and exclusion criteria and after signing the informed consent form. A total of 15 patients will be recruited, with 10 participants at the Florence center and 5 participants at the Sant'Angelo dei Lombardi center.
Cohort
Prospective
Evaluation with a Non-CE-Marked Robotic Device
DeviceParticipants are assessed using a non-CE-marked robotic device to evaluate its usability and safety for three-dimensional assessment of Unilateral Spatial Neglect (USN), and to collect preliminary data on reliability and validity. This evaluation is part of the study and does not constitute an assigned intervention.
Usability of the NeglectARm 3D system
Evaluation of usability of the NeglectARm 3D system using the HUBBI scale. The HUBBI (eHealth Usability Benchmarking Instrument) is a specialized tool for assessing the usability of eHealth services. It consists of 18 items rated on a 5-point Likert scale across seven key usability categories, focusing on the unique aspects of digital health platforms. This measure provides an indication of how repeatable, standardized, and safe the system is for the three-dimensional assessment of Unilateral Spatial Neglect (USN).
Feasibility of the NeglectARm 3D system
Evaluation of feasibility of the NeglectARm 3D system, assessed by recording the type and number of side effects or system failures occurring during robotic evaluation. This measure provides an indication of how repeatable, standardized, and safe the system is for the three-dimensional assessment of Unilateral Spatial Neglect (USN).
Behavioral Inattention Test (BIT) - Conventional subtest
The BIT is a short screening battery of tests used to identify and quantify Unilateral Spatial Neglect (USN), consisting of 6 conventional paper-and-pencil subtests and 9 behavioral subtests.The BIT Conventional subtest consists of 6 items: line crossing, letter cancelation, star cancellation, figure and shape copying, line bisection, and representational drawing. It provides a maximum score of 146.
Catherine Bergego Scale (CBS)
The Catherine Bergego Scale (CBS) is an observational tool designed to assess Unilateral Spatial Neglect (USN) in ecological contexts, such as activities of daily living. It consists of 10 items rated from 0 (no neglect) to 3 (severe neglect), with a maximum total score of 30; higher scores indicate greater neglect.
Motricity Index (MI)
The Motricity Index (MI) is an ordinal method of measuring limb strength. For the upper extremity, shoulder abduction, elbow flexion, and pinch grip are considered; for the lower extremity, hip flexion, knee extension, and ankle dorsiflexion are considered. It ranges from 0 (worse) to 100 (normal strength). Measurements are taken bilaterally.
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment. It ranges from 0 (worst) to 30 (best).
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Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Collaborator
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