An interventional study of Upper-limb planar robotic intervention in Stroke, Ischemic Stroke and Haemorrhagic Stroke, sponsored by Fondazione Don Carlo Gnocchi Onlus. Not yet recruiting at 1 site in Italy. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Other
The goal of this pilot clinical trial is to develop an integrated motor and cognitive rehabilitation program and evaluate the usability and acceptability of a new virtual reality scenario designed for the MOTORE device. This study will focus on the rehabilitation of the upper limbs in post-stroke patients with plegia and left-sided hemi-inattention. The main questions it aims to answer are:
Participants will undergo a total of 13 rehabilitation sessions, each lasting 45 minutes, using the new scenario, including an initial and final assessment.
Stroke in the right hemisphere can provoke both motor and cognitive symptoms. Hemi-inattention is a cognitive deficit typical of right hemispheric damage, with an incidence ranging from 12% to 95%. This deficit can manifest as difficulty in detecting and responding to stimuli from the left side of space, without any motor or sensory impairments that could justify the deficit. Hemi-inattention is usually associated with lesions in the inferior and superior parietal areas and, sometimes, in parts of the frontal area and the white matter connecting the parietal to the prefrontal areas. Hemi-inattention significantly compromises patients' quality of life and can negatively impact both motor and cognitive rehabilitation outcomes.
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 12 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
Compared within Ischemic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
Usability of the device
System Usability Scale (SUS)
Time frame: Evaluated at session 12 (after the treatment) at an average of 2 weeks
Acceptability of the device for the operator
Self-designed qualitative checklist
Time frame: Evaluated at session 12 (after the treatment) at an average of 2 weeks
Variation of symptoms connected to hemi-inattention
Apple test
Time frame: Evaluated at session 2 (before the beginning of treatment) and at session 12 (after treatment)
Functional direct effect of the device
Fugl-Meyer Assessment for Upper Limbs
Time frame: Evaluated at session 2 (before the beginning of treatment) and at session 12 (after treatment)
Start is estimated for Apr 2025; primary completion for Apr 2026, 12 months later.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 12 months is below that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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