Tridimensional Robotic Assessment of Neglect in Brain Injured Patients
NCT ID: NCT07290218
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
15 participants
OBSERVATIONAL
2026-01-01
2026-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Scuola Superiore Sant'Anna di Pisa
OTHER
Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Principal Investigators
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Eugenio Falotico, PhD
Role: STUDY_CHAIR
Scuola Superiore Sant'Anna di Pisa
Locations
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Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Sant'Angelo dei Lombardi, AV, Italy
IRCSS Fondazione Don Carlo Gnocchi
Florence, FI, Italy
Scuola Superiore Sant'Anna
Pisa, PI, Italy
Countries
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Central Contacts
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Facility Contacts
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Francesca Cecchi, MD
Role: primary
Andrea Mannini, PhD
Role: backup
Egidio Falotico, PhD
Role: primary
Sabina Nuti, PhD
Role: backup
References
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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.
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.
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.
Other Identifiers
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PNC00000007
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NEGLECTARM3D
Identifier Type: -
Identifier Source: org_study_id