Robotic rEhabilitation sCenario fOr patieNts With NeglECT
NCT06890481 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-04-03
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
Interventions
- 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.
Sponsors & Collaborators
-
Humanware S.r.l.
collaborator UNKNOWN -
Fondazione Don Carlo Gnocchi Onlus
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-01
- Primary Completion
- 2026-04-01
- Completion
- 2026-04-01
Countries
- Italy
Study Locations
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