Tridimensional Robotic Assessment of Neglect in Brain Injured Patients

NCT07290218 | Not Yet Recruiting

• 2 other identifiers: NEGLECTARM3DPNC00000007
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Neglect; Brain injured patients; Tridimensional robotic assessment; Force-sensitive robot system; Virtual reality (VR) headset; Collaborative robotic system

Outcome Measures

Primary Outcomes (2)

• Usability of the NeglectARm 3D system

  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

  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 Outcomes (10)

• Behavioral Inattention Test (BIT) - Conventional subtest

  Baseline and 3 weeks from baseline

• Catherine Bergego Scale (CBS)

  Baseline and 3 weeks from baseline

• Motricity Index (MI)

  Baseline and 3 weeks from baseline

• Montreal Cognitive Assessment (MoCA)

  Baseline and 3 weeks from baseline

• Convergent validity between NeglectARm 3D measures and Behavioral Inattention Test (BIT) - Conventional subtest

  Baseline and 3 weeks from baseline

Study Arms (1)

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

Interventions

Evaluation with a Non-CE-Marked Robotic Device 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.

USN Patients Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Scuola Superiore Sant'Anna di Pisa: collaborator
• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (3)

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

Sant'Angelo dei Lombardi, AV, 83054, Italy

Location

IRCSS Fondazione Don Carlo Gnocchi

Florence, FI, 50143, Italy

Location

Scuola Superiore Sant'Anna

Pisa, PI, 56127, Italy

Location

Related Publications (3)

• Kim YM, Chun MH, Yun GJ, Song YJ, Young HE. The effect of virtual reality training on unilateral spatial neglect in stroke patients. Ann Rehabil Med. 2011 Jun;35(3):309-15. doi: 10.5535/arm.2011.35.3.309. Epub 2011 Jun 30.

  PMID: 22506138 BACKGROUND

• Chen ZJ, Gu MH, He C, Xiong CH, Xu J, Huang XL. Robot-Assisted Arm Training in Stroke Individuals With Unilateral Spatial Neglect: A Pilot Study. Front Neurol. 2021 Jul 8;12:691444. doi: 10.3389/fneur.2021.691444. eCollection 2021.

  PMID: 34305798 BACKGROUND

• Fordell H, Bodin K, Eklund A, Malm J. RehAtt - scanning training for neglect enhanced by multi-sensory stimulation in Virtual Reality. Top Stroke Rehabil. 2016 Jun;23(3):191-9. doi: 10.1080/10749357.2016.1138670. Epub 2016 Mar 8.

  PMID: 27077985 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Eugenio Falotico, PhD

  Scuola Superiore Sant'Anna di Pisa

  STUDY CHAIR

Central Study Contacts

Egidio Falotico, PhD

CONTACT

+39050 883457; egidio.falotico@santannapisa.it

Francesca Cecchi, MD

CONTACT

fcecchi@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-09

Locations

IT (3)