StrokeRECONNECTNCT06890481
Robotic rEhabilitation sCenario fOr patieNts With NeglECT
A study testing Upper-limb planar robotic intervention in people with Stroke and Ischemic Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Ischemic Stroke, Haemorrhagic Stroke
- What is being tested?
- Upper-limb planar robotic intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of a diagnosis of right hemispheric stroke
- 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
Who cannot join
- Presence of cognitive decline prior to the event
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Fondazione Don Carlo Gnocchi onlus
Florence, Firenze, 50143
Fabio Carlotti, +3905573931, ctu@dongnocchi.it
About this study
Official title: Collaborative Development of a Virtual Reality Scenario, Integrated Into a Robotic Upper Limb Rehabilitation Device, for the Treatment of Unilateral Spatial Negligence (NSU) Through Mutisensory Stimulation: Feasibility and Usability Pilot Study
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:
- 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.
Read the detailed description
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.
- Conditions
- Stroke, Ischemic Stroke, Haemorrhagic Stroke, Neglect, Hemispatial
- Being tested
- Upper-limb planar robotic intervention
- Keywords
- stroke, robotics, end-effector, upper-limbs, rehabilitation, neglect, usability
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper-limb planar robotic interventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Upper limbs robotic intervention | Experimental | 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. Receives: Device: Upper-limb planar robotic intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the device
System Usability Scale (SUS)
Measured: Evaluated at session 12 (after the treatment) at an average of 2 weeks
Acceptability of the device for the operator
Self-designed qualitative checklist
Measured: Evaluated at session 12 (after the treatment) at an average of 2 weeks
Secondary outcomes (2)
Variation of symptoms connected to hemi-inattention
Apple test
Measured: 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
Measured: Evaluated at session 2 (before the beginning of treatment) and at session 12 (after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Humanware S.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890481
- Sponsor's protocol ID
- RECONNECT
- Acronym
- RECONNECT
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 2124720Robertson, 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.
PubMed 11931938Frassinetti 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.
PubMed 11311302Jacobs 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.
PubMed 22465475Mehrholz 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.
PubMed 32605587Bertani 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.
PubMed 28540536Varalta 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.
PubMed 25476507Choi 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.
PubMed 27606267Heins, 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.
PubMed 29400670
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Development of a Virtual Reality Scenario, Integrated Into a Robotic Upper Limb Rehabilitation Device, for the Treatment of Unilateral Spatial Negligence (NSU) Through Mutisensory Stimulation: Feasibility and Usability Pilot Study
- ClinicalTrials.gov ID
- NCT06890481
- Acronym / sponsor ID
- RECONNECT / RECONNECT
- Conditions
- Stroke, Ischemic Stroke, Haemorrhagic Stroke, Neglect, Hemispatial
- Keywords
- stroke, robotics, end-effector, upper-limbs, rehabilitation, neglect, usability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Humanware S.r.l.
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper limbs robotic intervention | Experimental | Device: Upper-limb planar robotic interventionThe 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of a diagnosis of right hemispheric stroke
- 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
Key exclusion criteria (10 listed)
- Presence of cognitive decline prior to the event
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper-limb planar robotic interventionThe 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. | Device | Upper limbs robotic intervention |
Primary outcome
Usability of the device
Time frame: Evaluated at session 12 (after the treatment) at an average of 2 weeks
System Usability Scale (SUS)
Acceptability of the device for the operator
Time frame: Evaluated at session 12 (after the treatment) at an average of 2 weeks
Self-designed qualitative checklist
2 secondary outcomes
Variation of symptoms connected to hemi-inattention
Time frame: Evaluated at session 2 (before the beginning of treatment) and at session 12 (after treatment)
Functional direct effect of the device
Time frame: Evaluated at session 2 (before the beginning of treatment) and at session 12 (after treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- BackgroundRobertson, I. H., & Hawkins, K. (1999). Limb activation and unilateral neglect. Neurocase, 5(2), 153-160
- BackgroundHeilman, 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.
- Background: PubMed 2124720Rizzolatti G, Berti A. Neglect as a neural representation deficit. Rev Neurol (Paris). 1990;146(10):626-34.
- BackgroundRobertson, I. H., Hogg, K., & McMillan, T. M. (1998). Rehabilitation of unilateral neglect: improving function by contralesional limb activation. Neuropsychological rehabilitation, 8(1), 19-29
- Background: PubMed 11931938Gainotti 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.
- Background: PubMed 11311302Frassinetti 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.
- Background: PubMed 22465475Jacobs 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.
- Background: PubMed 32605587Mehrholz 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.
- Background: PubMed 28540536Bertani 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.
- Background: PubMed 25476507Varalta 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.
- Background: PubMed 27606267Choi 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.
- BackgroundHeins, 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper-limb planar robotic intervention in people with Stroke and Ischemic Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Cecchi, Prof (+393388627184, fcecchi@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the device (time frame: Evaluated at session 12 (after the treatment) at an average of 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06890481, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.