Robotic rEhabilitation sCenario fOr patieNts With NeglECT
NCT ID: NCT06890481
Last Updated: 2025-04-03
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
NA
12 participants
INTERVENTIONAL
2025-04-01
2026-04-01
Brief Summary
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* The evaluation of the usability and acceptability of the newly developed scenario
* The evaluation of the effects of the new scenario on patients' hemi-inattention
* The evaluation of changes in upper limb functional parameters
Participants will undergo a total of 13 rehabilitation sessions, each lasting 45 minutes, using the new scenario, including an initial and final assessment.
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Detailed Description
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According to the theory of premotor spatial attention, brain attention and motor circuits are closely connected. Thus, it is possible to hypothesize that somatosensory activation in the contralesional space could stimulate the neural networks responsible for spatial representation and the conscious perception of stimuli. Some studies have attempted to verify this hypothesis by developing ad-hoc rehabilitation programs based on these theoretical principles. These studies can be divided into:
Studies investigating upper limb active mobilization, which require the activation of residual motor capabilities Studies investigating upper limb passive mobilization. It is widely accepted that hemi-inattention is a multisensory deficit, i.e., involving several sensory channels, and that a rehabilitation program based on joint stimulation of different channels can be effective.
Robot-assisted rehabilitation for the upper limbs, especially in hemiparetic patients, has gained growing interest in recent years, given the possibility of intensive treatment while still ensuring patient safety \[8-9\]. However, few studies have focused on the use of robotic devices, whose training modality often involves serious games, on cognitive aspects, particularly on hemi-inattention.
Even though preliminary and based on small sample sizes, these studies suggest a potential advantage of integrated cognitive and motor intervention for the rehabilitation of the upper limb and hemi-inattention. Indeed, the use of serious games and virtual reality scenarios can promote a synergistic effect of motor and cognitive stimulation. Furthermore, robotic rehabilitation can offer additional advantages, such as the "game effect," the ability to adapt the exercise difficulty level to the patient's performance, and the possibility of providing real-time feedback to the patient.
MOTORE is a planar end-effector robot for upper limb rehabilitation. In the literature, studies on the efficacy of this device in improving speed, strength, and spasticity of the upper limbs are available. However, no evidence is available regarding its use in treating hemi-inattention in post-stroke patients.
For this reason, this study aims to extend the use of the MOTORE device to the cognitive domain by creating a new virtual reality scenario for the robot. The scenario will consist of a sequential visual stimuli exercise with intra-session adaptive difficulty, designed to guide the patient's attention toward the neglected side of space through the combined use of visual and auditory stimuli and motor requests. The new scenario will be evaluated for usability with plegic post-stroke patients suffering from left hemi-inattention.
The novelty of the current study lies in the application of a multisensory approach, using auditory and visual stimuli, along with movement supported by the robot, to direct the patient's attention to the stimulus placed on the side of space affected by hemi-inattention.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Upper limbs robotic intervention
The intervention, which includes the upper limb robotic device MOTORE+ and the new scenario, consists of:
* Enrollment (Session 1): assessment of the inclusion criteria. Informed consent is obtained.
* Baseline evaluation (Session 2): assessment of upper limb function and hemi-inattention. Additionally, robotic performance parameters are collected.
* Training sessions (Sessions 3-12): these are the actual training sessions with the robotic device. Each session consists of three phases.
In the first phase, the therapist provides the patient with the necessary information for the session.
In the second phase, patients complete a pre-scenario session, during which the robotic parameters are adjusted.
In the third phase, the scenario is used for motor and cognitive training.
-Final evaluation (Session 13): final functional, clinical, and psychological assessments.
The sessions are conducted five times per week, each lasting 45 minutes.
Upper-limb planar robotic intervention
The training sessions consist of three phases.
In the first, the therapist provides the patient with the necessary information for the session.
In the second, patients undergo a pre-scenario phase, in which the parameters of the robot (ratio between virtual and physical space, viscosity, and weight) are adjusted.
In the third phase, the scenario is used for motor and cognitive exercise.
Specifically, the scenario consists of a reaching exercise involving sequential stimuli placed in different spatial areas. The scenario has adaptive characteristics regarding:
* Type of stimuli
* Size of the stimuli
* Visual and auditory cues
* Number of stimuli, related to the space in which they are displayed.
Each of these characteristics is adjusted differently according to the scenario's difficulty level. Regardless of the difficulty level, the scenario provides assistance as needed through a guided path (both visual and movement-based) toward the target.
Interventions
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Upper-limb planar robotic intervention
The training sessions consist of three phases.
In the first, the therapist provides the patient with the necessary information for the session.
In the second, patients undergo a pre-scenario phase, in which the parameters of the robot (ratio between virtual and physical space, viscosity, and weight) are adjusted.
In the third phase, the scenario is used for motor and cognitive exercise.
Specifically, the scenario consists of a reaching exercise involving sequential stimuli placed in different spatial areas. The scenario has adaptive characteristics regarding:
* Type of stimuli
* Size of the stimuli
* Visual and auditory cues
* Number of stimuli, related to the space in which they are displayed.
Each of these characteristics is adjusted differently according to the scenario's difficulty level. Regardless of the difficulty level, the scenario provides assistance as needed through a guided path (both visual and movement-based) toward the target.
Eligibility Criteria
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Inclusion Criteria
* Presence of a diagnosis of hemi-inattention (Apple test)
* Presence of left hemiplegia (Fugl-Meyer Assessment Upper Limb ≤58)
* Adjusted Montreal Cognitive Assessment \<20
* Written informed consent
Exclusion Criteria
* Presence of previous stroke events
* Presence of osteoarticular rigidity (e.g., ankylosis, functional limitations with traumatic or degenerative origin) or spasticity in the affected upper limb (Modified Ashworth Scale ≥3 on shoulder, elbow, or wrist)
* Inability to maintain a sitting position
* Presence of severe visual disabilities
* Recent injection of botulinum toxin in the upper limb or planned injection of botulinum toxin during the study period
* Orthopaedic, neurological, or psychiatric disorders that could interfere with the study procedures and motor or cognitive assessments
* Unstable fractures of the upper limb
* Severe osteoporosis
* Skin lesions on the upper limb
20 Years
80 Years
ALL
No
Sponsors
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Humanware S.r.l.
UNKNOWN
Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Locations
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IRCCS Fondazione Don Carlo Gnocchi onlus
Florence, Firenze, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Robertson, I. H., & Hawkins, K. (1999). Limb activation and unilateral neglect. Neurocase, 5(2), 153-160
Heilman, K. M., Watson, R. T., & Valenstein, E. (1993). Neglect and related disorders. In K. M. Heilman & E. Valenstein (Eds.), Clinical neuropsychology (pp. 279-336). Oxford University Press.
Rizzolatti G, Berti A. Neglect as a neural representation deficit. Rev Neurol (Paris). 1990;146(10):626-34.
Robertson, I. H., Hogg, K., & McMillan, T. M. (1998). Rehabilitation of unilateral neglect: improving function by contralesional limb activation. Neuropsychological rehabilitation, 8(1), 19-29
Gainotti G, Perri R, Cappa A. Left hand movements and right hemisphere activation in unilateral spatial neglect: a test of the interhemispheric imbalance hypothesis. Neuropsychologia. 2002;40(8):1350-5. doi: 10.1016/s0028-3932(01)00211-1.
Frassinetti F, Rossi M, Ladavas E. Passive limb movements improve visual neglect. Neuropsychologia. 2001;39(7):725-33. doi: 10.1016/s0028-3932(00)00156-1.
Jacobs S, Brozzoli C, Farne A. Neglect: a multisensory deficit? Neuropsychologia. 2012 May;50(6):1029-44. doi: 10.1016/j.neuropsychologia.2012.03.018. Epub 2012 Mar 28.
Mehrholz J, Pollock A, Pohl M, Kugler J, Elsner B. Systematic review with network meta-analysis of randomized controlled trials of robotic-assisted arm training for improving activities of daily living and upper limb function after stroke. J Neuroeng Rehabil. 2020 Jun 30;17(1):83. doi: 10.1186/s12984-020-00715-0.
Bertani R, Melegari C, De Cola MC, Bramanti A, Bramanti P, Calabro RS. Effects of robot-assisted upper limb rehabilitation in stroke patients: a systematic review with meta-analysis. Neurol Sci. 2017 Sep;38(9):1561-1569. doi: 10.1007/s10072-017-2995-5. Epub 2017 May 24.
Varalta V, Picelli A, Fonte C, Montemezzi G, La Marchina E, Smania N. Effects of contralesional robot-assisted hand training in patients with unilateral spatial neglect following stroke: a case series study. J Neuroeng Rehabil. 2014 Dec 5;11:160. doi: 10.1186/1743-0003-11-160.
Choi YS, Lee KW, Lee JH, Kim SB, Park GT, Lee SJ. The Effect of an Upper Limb Rehabilitation Robot on Hemispatial Neglect in Stroke Patients. Ann Rehabil Med. 2016 Aug;40(4):611-9. doi: 10.5535/arm.2016.40.4.611. Epub 2016 Aug 24.
Heins, S., Dehem, S., Montedoro, V., Dehez, B., Edwards, M., Stoquart, G., ... & Lejeune, T. (2017, April). Robotic-assisted serious game for motor and cognitive post-stroke rehabilitation. In 2017 IEEE 5th International Conference on Serious Games and Applications for Health (SeGAH) (pp. 1-8). IEEE.
Mazzoleni S, Battini E, Crecchi R, Dario P, Posteraro F. Upper limb robot-assisted therapy in subacute and chronic stroke patients using an innovative end-effector haptic device: A pilot study. NeuroRehabilitation. 2018;42(1):43-52. doi: 10.3233/NRE-172166.
Other Identifiers
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RECONNECT
Identifier Type: -
Identifier Source: org_study_id
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