Tridimensional Robotic Assessment of Neglect in Brain Injured Patients (NCT07290218) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Tridimensional Robotic Assessment of Neglect in Brain Injured Patients
Italy15 participantsStarted 2026-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Presence of language deficits (inability to complete the OCS test);
* Presence of cognitive decline prior to the stroke event;
* Presence of severe visual and/or hearing impairments;
* Language barriers;
* 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 medical devices whose functioning could be compromised (e.g., pacemaker, etc.);
* Object-centered neglect (assessed by the OCS Hearts Test; object asymmetry ± 2).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.