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NOT YET RECRUITING
NCT07290218

Tridimensional Robotic Assessment of Neglect in Brain Injured Patients

Sponsor: Fondazione Don Carlo Gnocchi Onlus

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

15

Start Date

2026-01-01

Completion Date

2026-11-30

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

DEVICE

Evaluation with a Non-CE-Marked Robotic Device

Participants are assessed using a non-CE-marked robotic device to evaluate its usability and safety for three-dimensional assessment of Unilateral Spatial Neglect (USN), and to collect preliminary data on reliability and validity. This evaluation is part of the study and does not constitute an assigned intervention.

Locations (3)

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

Sant'Angelo dei Lombardi, AV, Italy

IRCSS Fondazione Don Carlo Gnocchi

Florence, FI, Italy

Scuola Superiore Sant'Anna

Pisa, PI, Italy