Tridimensional Robotic Assessment of Neglect in Brain Injured Patients (NEGLECTARM3D)

December 4, 2025 updated by: Fondazione Don Carlo Gnocchi Onlus

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This observational, non-commercial study evaluates the usability and feasibility of the NeglectARm 3D system, a robotic and virtual reality-based tool for three-dimensional assessment of Unilateral Spatial Neglect (USN) in patients with brain injury due to ischemic or hemorrhagic stroke. Participants undergo two assessment sessions (T0 and T1), spaced three weeks apart, which include clinical neglect assessments using standard instruments and robotic evaluations with two test-retest trials per session.

The robotic component is the Franka Research 3 arm, a force-sensitive manipulator with seven degrees of freedom and torque sensors in each joint, providing industrial-quality pose repeatability of ±0.1 mm and minimal path deviation at high speeds. The virtual reality component is the Meta Quest 3 headset, which delivers high-resolution, smooth, and immersive visual feedback and tracks hand movement in real time using integrated sensors and RGB cameras.

During each session, participants reach sequentially presented stimuli in a 3D virtual space using their unaffected hand, in contact with the robotic end-effector. The system measures three-dimensional kinematics and provides assistance if the participant cannot reach a target independently. The robot operates in shared control mode, remaining transparent when the participant can reach a target autonomously ("patient-guided") and guiding the participant along the optimal trajectory when assistance is required ("robot-guided"), ensuring safe and natural movement.

The system records spatial positions and assistance parameters, enabling the construction of a map of target interactions and extraction of parameters for instrumental assessment of USN. Between assessment sessions, participants continue conventional rehabilitation. Data management includes checks for consistency and range, with source data verification performed by comparing robotic measurements with recorded observations. The study plans to enroll 15 patients, each completing two assessment sessions, to evaluate usability, feasibility, and preliminary reliability and validity of the system.

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • AV
      • Sant'Angelo dei Lombardi, AV, Italy, 83054
        • Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
        • Sub-Investigator:
          • Anna Estraneo
        • Sub-Investigator:
          • Alfonso Magliacano
    • FI
      • Florence, FI, Italy, 50143
        • IRCSS Fondazione Don Carlo Gnocchi
        • Contact:
        • Principal Investigator:
          • Francesca Cecchi, MD
        • Contact:
        • Sub-Investigator:
          • Badia B Hakiki
        • Sub-Investigator:
          • Stefano Doronzio
        • Sub-Investigator:
          • Chiara Pedrini
        • Sub-Investigator:
          • Daniela Maccanti
    • PI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The enrollment phase will be conducted at the IRCCS Fondazione Don Carlo Gnocchi in Florence (FI) and at the Fondazione Don Carlo Gnocchi in Sant'Angelo dei Lombardi (AV), in Italy. Each patient will be considered enrolled after assessment of inclusion and exclusion criteria and after signing the informed consent form. A total of 15 patients will be recruited, with 10 participants at the Florence center and 5 participants at the Sant'Angelo dei Lombardi center.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
USN Patients Cohort
This single cohort includes patients diagnosed with Unilateral Spatial Neglect (USN) who are undergoing conventional neuromotor rehabilitation. The study involves the evaluation of a non-CE-marked robotic device to assess its usability and safety for three-dimensional assessment of USN, as well as to collect preliminary data on the reliability and validity of the device's measurements.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the NeglectARm 3D system
Time Frame: Baseline and 3 weeks from baseline
Evaluation of usability of the NeglectARm 3D system using the HUBBI scale. The HUBBI (eHealth Usability Benchmarking Instrument) is a specialized tool for assessing the usability of eHealth services. It consists of 18 items rated on a 5-point Likert scale across seven key usability categories, focusing on the unique aspects of digital health platforms. This measure provides an indication of how repeatable, standardized, and safe the system is for the three-dimensional assessment of Unilateral Spatial Neglect (USN).
Baseline and 3 weeks from baseline
Feasibility of the NeglectARm 3D system
Time Frame: Baseline and 3 weeks from baseline
Evaluation of feasibility of the NeglectARm 3D system, assessed by recording the type and number of side effects or system failures occurring during robotic evaluation. This measure provides an indication of how repeatable, standardized, and safe the system is for the three-dimensional assessment of Unilateral Spatial Neglect (USN).
Baseline and 3 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral Inattention Test (BIT) - Conventional subtest
Time Frame: Baseline and 3 weeks from baseline
The BIT is a short screening battery of tests used to identify and quantify Unilateral Spatial Neglect (USN), consisting of 6 conventional paper-and-pencil subtests and 9 behavioral subtests.The BIT Conventional subtest consists of 6 items: line crossing, letter cancelation, star cancellation, figure and shape copying, line bisection, and representational drawing. It provides a maximum score of 146.
Baseline and 3 weeks from baseline
Catherine Bergego Scale (CBS)
Time Frame: Baseline and 3 weeks from baseline
The Catherine Bergego Scale (CBS) is an observational tool designed to assess Unilateral Spatial Neglect (USN) in ecological contexts, such as activities of daily living. It consists of 10 items rated from 0 (no neglect) to 3 (severe neglect), with a maximum total score of 30; higher scores indicate greater neglect.
Baseline and 3 weeks from baseline
Motricity Index (MI)
Time Frame: Baseline and 3 weeks from baseline
The Motricity Index (MI) is an ordinal method of measuring limb strength. For the upper extremity, shoulder abduction, elbow flexion, and pinch grip are considered; for the lower extremity, hip flexion, knee extension, and ankle dorsiflexion are considered. It ranges from 0 (worse) to 100 (normal strength). Measurements are taken bilaterally.
Baseline and 3 weeks from baseline
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline and 3 weeks from baseline
The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment. It ranges from 0 (worst) to 30 (best).
Baseline and 3 weeks from baseline
Convergent validity between NeglectARm 3D measures and Behavioral Inattention Test (BIT) - Conventional subtest
Time Frame: Baseline and 3 weeks from baseline
Convergent validity will be assessed by calculating correlation coefficients between instrumental (robot-based) measures of Unilateral Spatial Neglect (USN) recorded by the NeglectARm 3D system and the total score of the BIT Conventional subtest (BIT-C). Correlations between instrumental and clinical measures will be calculated using Pearson or Spearman correlation coefficients, depending on variable distribution. The outcome measure is the correlation coefficient between each instrumental measure and the BIT-C total score at each time point.
Baseline and 3 weeks from baseline
Convergent validity between NeglectARm 3D measures and Catherine Bergego Scale (CBS)
Time Frame: Baseline and 3 weeks from baseline
Convergent validity will be assessed by calculating correlation coefficients between instrumental (robot-based) measures of Unilateral Spatial Neglect (USN) recorded by the NeglectARm 3D system and the total score of the CBS. Correlations between instrumental and clinical measures will be calculated using Pearson or Spearman correlation coefficients, depending on variable distribution. The outcome measure is the correlation coefficient between each instrumental measure and the CBS total score at each time point.
Baseline and 3 weeks from baseline
Test-retest reliability of total test execution time recorded by NeglectARm 3D
Time Frame: Within-session at baseline and within-session at 3 weeks from baseline
Test-retest reliability of total test execution time recorded by the NeglectARm 3D system will be evaluated by comparing two repetitions of the robotic assessment performed within the same session at T0 and at T1. The outcome measure is the Intraclass Correlation Coefficient (ICC) between the two repetitions at each time point.
Within-session at baseline and within-session at 3 weeks from baseline
Test-retest reliability of number of targets identified without robotic assistance
Time Frame: Within-session at baseline and within-session at 3 weeks from baseline
Test-retest reliability of the number of targets identified without robotic assistance during the NeglectARm 3D task will be evaluated by comparing two repetitions of the robotic assessment performed within the same session at T0 and at T1. The outcome measure is the Intraclass Correlation Coefficient (ICC) between the two repetitions at each time point.
Within-session at baseline and within-session at 3 weeks from baseline
Test-retest reliability of the number of targets not identified autonomously
Time Frame: Within-session at baseline and within-session at 3 weeks from baseline
Test-retest reliability of the number of targets not identified autonomously (i.e., targets for which the robot had to provide assistance) during the NeglectARm 3D task will be evaluated by comparing two repetitions of the robotic assessment performed within the same session at T0 and at T1. The outcome measure is the Intraclass Correlation Coefficient (ICC) between the two repetitions at each time point.
Within-session at baseline and within-session at 3 weeks from baseline
Test-retest reliability of total robot intervention time
Time Frame: Within-session at baseline and within-session at 3 weeks from baseline
Test-retest reliability of total robot intervention time during the NeglectARm 3D task will be evaluated by comparing two repetitions of the robotic assessment performed within the same session at T0 and at T1. The outcome measure is the Intraclass Correlation Coefficient (ICC) between the two repetitions at each time point.
Within-session at baseline and within-session at 3 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

Scuola Superiore Sant'Anna di Pisa

Investigators

  • Study Chair: Eugenio Falotico, PhD, Scuola Superiore Sant'Anna di Pisa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEGLECTARM3D
  • PNC00000007 (Other Grant/Funding Number: Italian Ministry of University and Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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