Robotic rEhabilitation sCenario fOr patieNts With NeglECT

NCT06890481 | Not Yet Recruiting

• 1 other identifier: RECONNECT
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Ischemic Stroke; Haemorrhagic Stroke; Neglect, Hemispatial

Keywords

stroke; robotics; end-effector; upper-limbs; rehabilitation; neglect; usability

Outcome Measures

Primary Outcomes (2)

• Usability of the device

  System Usability Scale (SUS)

  Evaluated at session 12 (after the treatment) at an average of 2 weeks

• Acceptability of the device for the operator

  Self-designed qualitative checklist

  Evaluated at session 12 (after the treatment) at an average of 2 weeks

Secondary Outcomes (2)

• Variation of symptoms connected to hemi-inattention

  Evaluated at session 2 (before the beginning of treatment) and at session 12 (after treatment)

• Functional direct effect of the device

  Evaluated at session 2 (before the beginning of treatment) and at session 12 (after treatment)

Study Arms (1)

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.

Device: Upper-limb planar robotic intervention

Interventions

Upper-limb planar robotic intervention DEVICE

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.

Upper limbs robotic intervention

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Humanware S.r.l.: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi onlus

Florence, Firenze, 50143, Italy

Location

Related Publications (13)

• Robertson, I. H., & Hawkins, K. (1999). Limb activation and unilateral neglect. Neurocase, 5(2), 153-160

  BACKGROUND

• 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.

  BACKGROUND

• Rizzolatti G, Berti A. Neglect as a neural representation deficit. Rev Neurol (Paris). 1990;146(10):626-34.

  PMID: 2124720 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 11931938 BACKGROUND

• 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.

  PMID: 11311302 BACKGROUND

• 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.

  PMID: 22465475 BACKGROUND

• 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.

  PMID: 32605587 BACKGROUND

• 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.

  PMID: 28540536 BACKGROUND

• 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.

  PMID: 25476507 BACKGROUND

• 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.

  PMID: 27606267 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29400670 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Perceptual Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Francesca Cecchi, Prof

CONTACT

+393388627184; fcecchi@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 24, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

IT (1)