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

15 Participants
are divided into 1 treatment group

Locations

3
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo83054, Sant'Angelo dei LombardiAV, Italy
IRCSS Fondazione Don Carlo Gnocchi50143, FlorenceFI, Italy
Scuola Superiore Sant'Anna56127, PisaPI, Italy

Sponsors and collaborators

Fondazione Don Carlo Gnocchi Onlus

Lead sponsor

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Collaborator