Tridimensional Robotic Assessment of Neglect in Brain Injured Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus

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

Sponsors and collaborators

Fondazione Don Carlo Gnocchi Onlus

Lead sponsor

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Collaborator