Exoskeleton DeviceIVSNCT07860840
Efficacy of Intensive Visual Simulation (IVS) Before Exoskeleton-assisted Step Training in Patients With Hemisensory Syndrome With Brain Injury of Vascular Etiology.
A study testing Rehabilitation treatment with IVS before step training using an exoskeleton and Rehabilitation treatment with step training using an exoskeleton in people with Exoskeleton Device and Sensory Disorder, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Exoskeleton Device, Sensory Disorder, Brain Injuries, Vascular
- What is being tested?
- Rehabilitation treatment with IVS before step training using an exoskeleton and Rehabilitation treatment with step training using an exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 21 Apr 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria Hospital
Negrar, Italy, 37024
Elena Rossato, Dr.ssa, +39 045.6014597, elena.rossato@sacrocuore.it
About this study
Official title: 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.
Read the 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).
- Being tested
- Rehabilitation treatment with IVS before step training using an exoskeleton, Rehabilitation treatment with step training using an exoskeleton
- Keywords
- EKSO, Intensive Visual Simulation, Exoskeleton device, sensory hemisyndrome, Brain Injuries, Vascular
- Medical subject headings
- Sensation Disorders, Cerebrovascular Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation treatment with IVS before step training using an exoskeletonDevice
- 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 exoskeletonDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation treatment with IVS before step training using an exoskeleton | Experimental | Not described Receives: Device: Rehabilitation treatment with IVS before step training using an exoskeleton |
| Rehabilitation treatment with step training using an exoskeleton | Active comparator | Not described Receives: Device: Rehabilitation treatment with step training using an exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Timepoint 1 (3 weeks after)
Secondary outcomes (9)
Revised Nottingham Sensory Assessment Scale Score
Revised Nottingham Sensory Assessment Scale Score for evaluating sensitivity in the paretic hemibody
Measured: 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
Measured: 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
Measured: Baseline to Timepoint 2 (7 weeks after)
Ashworth Scale (MAS)
Ashworth Scale (MAS) for Assessing Muscle Tone
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Timepoint 2 (7 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start21 Apr 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exoskeleton DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860840
- Sponsor's protocol ID
- 2023-41
- Acronym
- IVS
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07860840
- Acronym / sponsor ID
- IVS / 2023-41
- Keywords
- EKSO, Intensive Visual Simulation, Exoskeleton device, sensory hemisyndrome, Brain Injuries, Vascular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 21 Apr 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation treatment with IVS before step training using an exoskeleton | Experimental | Device: Rehabilitation treatment with IVS before step training using an exoskeleton |
| Rehabilitation treatment with step training using an exoskeleton | Active comparator | Device: Rehabilitation treatment with step training using an exoskeleton |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Rehabilitation treatment with IVS before step training using an exoskeleton |
| 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. | Device | Rehabilitation treatment with step training using an exoskeleton |
Primary outcome
Efficacy of preparatory treatment with Intensive Visual Simulation (IVS) for step training with an exoskeleton (EKSO)
Time frame: Baseline to Timepoint 1 (3 weeks after)
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)
Time frame: Baseline to Timepoint 1 (3 weeks after)
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.
9 secondary outcomes
Revised Nottingham Sensory Assessment Scale Score
Time frame: Baseline to Timepoint 2 (7 weeks after)
Range of Motion (ROM) Values for the Tibiotarsal and Knee Joints
Time frame: Baseline to Timepoint 2 (7 weeks after)
Presence/absence of tendon retractions
Time frame: Baseline to Timepoint 2 (7 weeks after)
Ashworth Scale (MAS)
Time frame: Baseline to Timepoint 2 (7 weeks after)
Minimum number of sessions required to achieve independent walking with assistive devices
Time frame: Baseline to Timepoint 1 (3 weeks after)
Percentage of assistance provided by EKSO
Time frame: Baseline to Timepoint 2 (7 weeks after)
Number of steps taken during a training session with EKSO
Time frame: 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
Time frame: 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
Time frame: At Timepoint 2 (7 weeks after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation treatment with IVS before step training using an exoskeleton and Rehabilitation treatment with step training using an exoskeleton in people with Exoskeleton Device and Sensory Disorder, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvia Malo, Dr. (+39 045.6014877, ricerca.clinica@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of preparatory treatment with Intensive Visual Simulation (IVS) for step training with an exoskeleton (EKSO) (time frame: Baseline to Timepoint 1 (3 weeks after)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.