Clinical Trial

Tridimensional Robotic Assessment of Neglect in Brain Injured Patients

Study acronym: NEGLECTARM3D
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07290218
Lead Sponsor Fondazione Don Carlo Gnocchi ETS
Collaborators: Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Conditions Neglect, Brain Injured Patients, Stroke, Unilateral Spatial Neglect (USN), Post-stroke Cognitive Impairment
Enrollment 15 participants
Start Date 2026-01-01
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-18