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

Experimental Pilot Study: Efficacy of Preparatory Treatment With Intensive Visual Simulation (IVS) Prior to Step Training With an Exoskeleton (EKSO) in Patients With Hemisensory Syndrome Resulting From Acquired Brain Injury of Vascular Etiology.

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.

Study Overview

• Status: Recruiting
• Conditions: Sensory Disorder; Exoskeleton Device; Brain Injuries, Vascular
• Intervention / Treatment: Device: Rehabilitation treatment with IVS before step training using an exoskeleton; Device: Rehabilitation treatment with step training using an exoskeleton

Detailed Description

Enrolled patients will be randomized to one of the two rehabilitation treatment arms included in the trial.

• Arm A: Rehabilitation treatment with IVS before physiotherapy-based and robotic gait training using an exoskeleton.
• Arm B: Rehabilitation treatment with physiotherapy-based and robotic step training using an exoskeleton.

Training will last:

• 15 minutes of IVS (only for Arm A)
• 30 minutes of EKSO training (which in Arm A will be performed after IVS treatment)
• 45 minutes of non-robotic motor therapy following robotic treatment.

Each rehabilitation session will last a maximum of approximately 1.5 hours and will be repeated 5 days a week for 3 weeks.

Clinical evaluations will be conducted by a physician who is unaware of the rehabilitation treatment the patient has undergone (the patient will be appropriately informed of the need not to disclose the type of rehabilitation received to the evaluating physician).

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elvia Malo, Dr.; Phone Number: +39 045.6014877; Email: ricerca.clinica@sacrocuore.it

Study Locations

• Italy
  • Italy
    • Negrar, Italy, Italy, 37024
      • Recruiting
      • IRCCS Sacro Cuore Don Calabria Hospital
      • Contact: Elena Rossato, Dr.ssa; Phone Number: +39 045.6014597; Email: elena.rossato@sacrocuore.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rehabilitation treatment with IVS before step training using an exoskeleton	Device: Rehabilitation treatment with IVS before step training using an exoskeleton; 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.
Active Comparator: Rehabilitation treatment with step training using an exoskeleton	Device: Rehabilitation treatment with step training using an exoskeleton; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Timepoint 1 (3 weeks after)
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.	Baseline to Timepoint 1 (3 weeks after)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised Nottingham Sensory Assessment Scale Score	Revised Nottingham Sensory Assessment Scale Score for evaluating sensitivity in the paretic hemibody	Baseline to Timepoint 2 (7 weeks after)
Range of Motion (ROM) Values for the Tibiotarsal and Knee Joints	Range of Motion (ROM) Values for Assessment of the Tibiotarsal and Knee Joints	Baseline to Timepoint 2 (7 weeks after)
Presence/absence of tendon retractions	Presence/absence of tendon retractions in the knee and tibiotarsal flexor-extensor muscles and the tibiotarsal pronator-supinator muscles	Baseline to Timepoint 2 (7 weeks after)
Ashworth Scale (MAS)	Ashworth Scale (MAS) for Assessing Muscle Tone	Baseline to Timepoint 2 (7 weeks after)
Minimum number of sessions required to achieve independent walking with assistive devices	Evaluation of the minimum number of sessions required to achieve independent walking with assistive devices.	Baseline to Timepoint 1 (3 weeks after)
Percentage of assistance provided by EKSO	Percentage of assistance provided by EKSO as recorded by the machine after 10 minutes, after 20 minutes, and at the end of 30 minutes of robotic training.	Baseline to Timepoint 2 (7 weeks after)
Number of steps taken during a training session with EKSO	Number of steps taken during a single 30-minute training session with EKSO, as recorded by the machine.	Baseline to Timepoint 2 (7 weeks after)
Assessment of the maintenance of skills acquired through preparatory training, with or without Intensive Visual Simulation (IVS), for exoskeleton (EKSO) step training	Values after 7 weeks from the Timed Up and Go Test. 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.	Timepoint 2 (7 weeks after baseline)
Assessment of the maintenance of skills acquired through preparatory training, with or without Intensive Visual Simulation (IVS), for exoskeleton (EKSO) step training	Values after 7 weeks from the Berg Balance Scale. The scale assesses static and minimal dynamic balance, as well as the risk of falling. The score ranges from 0 to 56.	At Timepoint 2 (7 weeks after baseline)

Collaborators and Investigators

• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: September 15, 2026
• First Submitted That Met QC Criteria: September 30, 2026
• First Posted (Actual): October 6, 2026

Study Record Updates

• Last Update Posted (Actual): October 6, 2026
• Last Update Submitted That Met QC Criteria: September 30, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: EKSO; Exoskeleton device; Intensive Visual Simulation; sensory hemisyndrome; Brain Injuries, Vascular
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Trauma, Nervous System; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sensation Disorders; Cerebrovascular Trauma; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Rehabilitation
• Other Study ID Numbers: 2023-41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No