NCT07290218Not yet recruiting
Tridimensional Robotic Assessment of Neglect in Brain Injured Patients
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 15 (estimated)
- First submitted
- 21 Nov 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Stroke
- NCT number
- NCT07290218
What you commit to
- Study type: Observational
- Planned participants: 15
- From 1 Jan 2026 to the primary completion date, 31 Oct 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of cognitive decline prior to the stroke event;
Other illness
- 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;
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCSS Fondazione Don Carlo Gnocchi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Scuola Superiore Sant'Anna Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo Coordinator of this site? Confirm its status | Sant'Angelo dei Lombardi | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.