MedTrace Logo

Tridimensional Robotic Assessment of Neglect in Brain Injured Patients

NCT07290218 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Neglect
  • Brain Injured Patients
  • Stroke
  • Unilateral Spatial Neglect (USN)
  • Post-stroke Cognitive Impairment

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.

Sponsors & Collaborators

  • Scuola Superiore Sant'Anna di Pisa

    collaborator OTHER

  • Fondazione Don Carlo Gnocchi Onlus

    lead OTHER

Principal Investigators

  • Eugenio Falotico, PhD · Scuola Superiore Sant'Anna di Pisa

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-10-31
Completion
2026-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290218 on ClinicalTrials.gov