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Tridimensional Robotic Assessment of Neglect in Brain Injured Patients

NCT07290218 · Fondazione Don Carlo Gnocchi ETS · Updated 18 Dec 2025

What is being tested
Evaluation with a Non-CE-Marked Robotic Device
For
Neglect; Brain Injured Patients; Stroke; Unilateral Spatial Neglect (USN); Post-stroke Cognitive Impairment
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 15 people. The full rules are on the registry page.
Where
Italy (3 sites)
When
Starts or started 1 Jan 2026, ends 30 Nov 2026. Registered 18 Dec 2025.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT07290218

Sites

  • Fondazione Don Carlo Gnocchi, Polo Specialistico RiabilitativoSant'Angelo dei Lombardi, AV, Italy
  • IRCSS Fondazione Don Carlo GnocchiFlorence, FI, Italy
  • Scuola Superiore Sant'AnnaPisa, PI, Italy