NCT Number: NCT07290218
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo, Sant'Angelo dei Lombardi, AV, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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).
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Egidio Falotico, PhD
CONTACT
Francesca Cecchi, MD
CONTACT
Fondazione Don Carlo Gnocchi ETS
Other
Acronym: NEGLECTARM3D
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