Robotic rEhabilitation sCenario fOr patieNts With NeglECT
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Upper-limb planar robotic intervention
DeviceThe 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Upper limbs robotic interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Usability of the device
System Usability Scale (SUS)
Time frame
Evaluated at session 12 (after the treatment) at an average of 2 weeks2
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 weeksSecondary outcomes
1
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)2
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Humanware S.r.l.
Collaborator
Source ClinicalTrials.gov
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