Tridimensional Robotic Assessment of Neglect in Brain Injured Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Usability of the NeglectARm 3D system [Срок оценки: Baseline and 3 weeks from baseline]
• Feasibility of the NeglectARm 3D system [Срок оценки: Baseline and 3 weeks from baseline]

Вторичные конечные точки (10)

• Behavioral Inattention Test (BIT) - Conventional subtest [Срок оценки: Baseline and 3 weeks from baseline]
• Catherine Bergego Scale (CBS) [Срок оценки: Baseline and 3 weeks from baseline]
• Motricity Index (MI) [Срок оценки: Baseline and 3 weeks from baseline]
• Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline and 3 weeks from baseline]
• Convergent validity between NeglectARm 3D measures and Behavioral Inattention Test (BIT) - Conventional subtest [Срок оценки: Baseline and 3 weeks from baseline]
• Convergent validity between NeglectARm 3D measures and Catherine Bergego Scale (CBS) [Срок оценки: Baseline and 3 weeks from baseline]
• Test-retest reliability of total test execution time recorded by NeglectARm 3D [Срок оценки: Within-session at baseline and within-session at 3 weeks from baseline]
• Test-retest reliability of number of targets identified without robotic assistance [Срок оценки: Within-session at baseline and within-session at 3 weeks from baseline]
• Test-retest reliability of the number of targets not identified autonomously [Срок оценки: Within-session at baseline and within-session at 3 weeks from baseline]
• Test-retest reliability of total robot intervention time [Срок оценки: Within-session at baseline and within-session at 3 weeks from baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 3 центра

• Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Sant'Angelo dei Lombardi
• IRCSS Fondazione Don Carlo Gnocchi — Florence
• Scuola Superiore Sant'Anna — Pisa

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07290218 · NEGLECTARM3D · PNC00000007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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