Robotic rEhabilitation sCenario fOr patieNts With NeglECT (RECONNECT)

March 31, 2025 updated by: Fondazione Don Carlo Gnocchi Onlus

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Firenze, Italy, 50143
        • IRCCS Fondazione Don Carlo Gnocchi ONLUS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the device
Time Frame: Evaluated at session 12 (after the treatment) at an average of 2 weeks
System Usability Scale (SUS)
Evaluated at session 12 (after the treatment) at an average of 2 weeks
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
Evaluated at session 12 (after the treatment) at an average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of symptoms connected to hemi-inattention
Time Frame: Evaluated at session 2 (before the beginning of treatment) and at session 12 (after treatment)
Apple test
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)
Fugl-Meyer Assessment for Upper Limbs
Evaluated at session 2 (before the beginning of treatment) and at session 12 (after treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

Humanware S.r.l.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECONNECT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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