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Efficacy of Intensive Visual Simulation (IVS) Before Exoskeleton-assisted Step Training in Patients With Hemisensory Syndrome With Brain Injury of Vascular Etiology.

Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar • ClinicalTrials.gov ID: NCT07860840

Registry updated: 2026-10-06

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Description

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.

Interventions

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.

Eligibility criteria

Inclusion Criteria: * 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 * Clinical stability * Trunk control while standing * Signature of the Informed Consent Form for participation in the study and for the processing of personal data Exclusion Criteria: * 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 * Patients with severe ideomotor apraxia * Patients with cognitive or mental disorders * Patients not eligible for EKSO: * Severe comorbid conditions: infections, circulatory, cardiac, or pulmonary diseases, pressure ulcers. * Severe spasticity (level 4 on the modified Ashworth scale). * Spinal instability or unhealed fractures of the limbs or pelvis. * Heterotopic ossification. * Psychiatric or cognitive conditions that may interfere with the proper use of the device. * Pregnant women. * Reduced tolerance for standing due to orthostatic hypotension. * Range of motion (ROM) limitations that would prevent the patient from achieving a normal bilateral gait pattern or performing normal transitions from a seated to a standing position and vice versa: Bilateral hip flexion less than 110°, knee flexion contracture greater than 12°, or inability to achieve neutral dorsiflexion of 0° with knee flexion up to 12°. * Leg length discrepancy greater than 1.27 cm for the upper leg and 1.9 cm for the lower leg. * Unresolved deep vein thrombosis. * Uncontrolled autonomic dysreflexia. * Lower limb prostheses.

Conditions

Exoskeleton Device Sensory Disorder Brain Injuries, Vascular

Locations

IRCCS Sacro Cuore Don Calabria Hospital — Negrar, Italy, Italy

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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