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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Don Carlo Gnocchi Onlus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Scuola Superiore Sant'Anna di Pisa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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