Clinical trial involving a medical device, not intended for CE marking, randomized, blinded to evaluate the efficacy of preparatory treatment with Intensive Visual Simulation 4 (IVS) prior to exoskeleton-assisted (EKSO) step training in achieving independent ambulation in hemiparetic patients with impaired proprioceptive sensation. Patients will be randomized into two groups: one group in which patients will undergo IVS treatment before physiotherapy and robotic step training with an exoskeleton; and one group in which patients will undergo only physiotherapy and robotic step training with an exoskeleton.
Male and female patients aged 18 to 80 years (both ends included).
Diagnosis of hemiparesis/plegia with proprioceptive sensory deficit due to a cerebrovascular event within the last 6 months
Orientation in the 3 domains (space, time, and person)
Cooperation
Patients aged < 18 years and > 80 years
Patients who are disoriented in at least one of the three domains (space, time, and person)
Non-cooperative patients
Patients with global aphasia
Parallel
Rehabilitation treatment with IVS before step training using an exoskeleton
Device* 15 minutes of IVS: The physical therapist will show the patient a pre-recorded sequence of movements and activities involving the lower limb. Patient will observe the movements on a screen positioned to cover the paretic limb and will then be ask to repeat them. * 30 minutes of EKSO training:The physical therapist will set up the training using a single program defined as "assistive" to observe the degree of dependence on the machine throughout the course of treatment and will maintain this setting for all sessions, documenting the percentage changes in the level of assistance required. * 45 minutes of non-robotic motor therapy following the robotic treatment. The physical therapist will perform motor treatments involving mobilization, muscle strengthening, and standing with the goal of improving the patient's ability to perform transfers and maintain an upright position independently. The rehabilitation treatment session will be repeated 5 days a week for 3 weeks.
Rehabilitation treatment with step training using an exoskeleton
Device* 30 minutes of EKSO training: The physical therapist will set up the training using a single program defined as "assistive" to observe the degree of dependence on the machine throughout the course of treatment and will maintain this setting for all sessions, documenting the percentage changes in the level of assistance required. * 45 minutes of non-robotic motor therapy following the robotic treatment. The physical therapist will perform motor treatments involving mobilization, muscle strengthening, and standing with the goal of improving the patient's ability to perform transfers and maintain an upright position independently. The rehabilitation treatment session will be repeated 5 days a week for 3 weeks.
Efficacy of preparatory treatment with Intensive Visual Simulation (IVS) for step training with an exoskeleton (EKSO)
Scores on the Berg Balance Scale from baseline to the end of treatment. The scale assesses static and minimal dynamic balance, as well as the risk of falling. The score ranges from 0 to 56.
Efficacy of preparatory treatment with Intensive Visual Simulation (IVS) for step training with an exoskeleton (EKSO)
Scores on the Timed Up and Go test from baseline to the end of treatment. The test measures, in seconds, the time it takes a patient to stand up from a chair with armrests, walk 3 meters, turn around, walk back, and sit down again.
Revised Nottingham Sensory Assessment Scale Score
Revised Nottingham Sensory Assessment Scale Score for evaluating sensitivity in the paretic hemibody
Range of Motion (ROM) Values for the Tibiotarsal and Knee Joints
Range of Motion (ROM) Values for Assessment of the Tibiotarsal and Knee Joints
Presence/absence of tendon retractions
Presence/absence of tendon retractions in the knee and tibiotarsal flexor-extensor muscles and the tibiotarsal pronator-supinator muscles
Ashworth Scale (MAS)
Ashworth Scale (MAS) for Assessing Muscle Tone
Click on the lead sponsor to view all of their trials.
