About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Evaluation with a Non-CE-Marked Robotic Device
Treatment groups
Sponsors and collaborators
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Collaborator