Tridimensional Robotic Assessment of Neglect in Brain Injured Patients
Key facts
- Where
- Florence, Pisa, and Sant'Angelo dei Lombardi, ItalySee the 3 sites
Where in Italy
- IRCSS Fondazione Don Carlo GnocchiFlorence, ItalyNo longer taking part
- Scuola Superiore Sant'AnnaPisa, ItalyNo longer taking part
- Fondazione Don Carlo Gnocchi, Polo Specialistico RiabilitativoSant'Angelo dei Lombardi, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Don Carlo Gnocchi ETS
- Trial code
- NCT07290218
- Record updated
- 18 December 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Presence of cognitive decline prior to the stroke event; Orthopedic, neurological, or psychiatric conditions that could interfere with the study or with the assessment of motor and cognitive function; Uncontrolled epilepsy despite antiepileptic treatment; Behavioral disorders that may interfere with study participation; Presence of language deficits (inability to complete the OCS test); Presence of severe visual and/or hearing impairments; Language barriers; Presence of medical devices whose functioning could be compromised (e.g., pacemaker, etc.); Object-centered neglect (assessed by the OCS Hearts Test; object asymmetry ± 2).