StrokeNCT06780488
Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors
A study testing Real Visual-Vestibuar Rehabilitation in people with Stroke, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial summary
This pilot study aims to evaluate the effect of a specfic Virtual-Reality-Based rehabilitation training in patients with stroke. A total of 38 patients with stroke (more than 6 months from the acute event), recruited from the services of the Fondazione Santa Lucia IRCCS in Rome, will be included in the present study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Real Visual-Vestibuar Rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2025to 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
- Subjects with a history of hemorrhagic or ischemic stroke (more than 6 months from the acute event)
- Patients aged between 18 and 80 years
- Absence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (MiniMentalState Evaluation > 24)
- Functional Ambulation Category ≥ 3
- Absence of associated orthopedic, visual, and/or neurological issues (clinically assessed) that may affect participation in the study
Who cannot join
- Patients with stroke (less than 6 months from the acute event);
- Patients aged under 18 and over 80;
- Presence of associated orthopedic, visual, and/or neurological issues (clinically assessed) that may affect participation in the study;
- Presence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (MiniMentalState Evaluation ≤ 24);
- Epilepsy.
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
Fondazione Santa Lucia IRCCS
Roma, RM, 00142
Sara De Angelis, MSc, 00390651501772, s.deangelis@hsantalucia.it
About this study
This pilot study aims to evaluate the effect of a specfic Virtual-Reality-Based rehabilitation training in patients with stroke. A total of 38 patients with stroke (more than 6 months from the acute event), recruited from the services of the Fondazione Santa Lucia IRCCS in Rome, will be included in the present study. Participants will be randomized into two groups: a Real group and a Sham group. Both groups will undergo a rehabilitation intervention using an immersive virtual reality system. The Real group will be exposed to scenarios containing specific stimuli for the visuo-vestibular system, while the Sham group will be exposed to the same scenarios but without specific stimuli. All participants in both groups will undergo 12 treatment sessions (three times a week), each lasting 20 minutes. All treatments will be conducted by physiotherapists specialized in neurological and vestibular rehabilitation. Patients will be assessed before the start of the treatment, at the end of the intervention, and one month after its completion, in order to evaluate the effects of the experimental training on balance and gait, and on the patient's perceived quality of life. Another aim will be to assess the user's satisfaction with the new proposed protocol.
- Conditions
- Stroke
- Being tested
- Real Visual-Vestibuar Rehabilitation, Sham Rehabilitation
- Keywords
- Stroke, Vestibular Rehabilitation, Virtual Reality, Balance, Gait, Quality of Life
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Visual-Vestibuar RehabilitationOther
The "Real Visual-Vestibular Rehabilitation" protocol will consist of specific exercises aimed at stimulating the visuo-vestibular function within immersive virtual reality environments replicating daily life situations. Patients will perform exercises in two types of contexts. In all exercises, patients will be free to move within a room large enough to complete the tasks. Walking during the exercises can also be performed with assistive devices, to make the context as close as possible to the patient's daily life. During the exercises, patients will be supervised by a physiotherapist specialized in neurological and vestibular rehabilitation.The protocol will last 20 minutes, with 10 minutes dedicated to each exercise.
Sham RehabilitationOther
The "Sham Vestibular Rehabilitation" protocol will involve the use of the same immersive virtual reality contexts and will aim to achieve the same objectives as the Real Visual-Vestibular Rehabilitation protocol, but without the "unexpected" stimuli. In both exercises, patients will be free to move within a room large enough to complete the tasks. Walking during the session can also be performed with assistive devices, to make the context as close as possible to the patient's daily life. During the exercises, patients will be supervised by a physiotherapist specialized in neurological and vestibular rehabilitation. The protocol will last 20 minutes, with 10 minutes dedicated to each exercise.
| Study group | Role | What they receive |
|---|---|---|
| Real | Experimental | Not described Receives: Other: Real Visual-Vestibuar Rehabilitation |
| Control | Sham comparator | Not described Receives: Other: Sham Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-BESTest
The Mini-BESTest is a clinical scale used to assess balance and fall risk, consisting of 14 items covering anticipatory, reactive, dynamic balance, and transfers.
Scoring: ranges from 0 (worst balance) to 28 (best balance); higher scores indicate better performance, while lower scores indicate greater fall risk or postural deficits.
Measured: T0 (Baseline)
Mini-BESTest
The Mini-BESTest is a clinical scale used to assess balance and fall risk, consisting of 14 items covering anticipatory, reactive, dynamic balance, and transfers.
Scoring: ranges from 0 (worst balance) to 28 (best balance); higher scores indicate better performance, while lower scores indicate greater fall risk or postural deficits.
Measured: T1 (4 weeks from the baseline - end of treatment period)
Mini-BESTest
The Mini-BESTest is a clinical scale used to assess balance and fall risk, consisting of 14 items covering anticipatory, reactive, dynamic balance, and transfers.
Scoring: ranges from 0 (worst balance) to 28 (best balance); higher scores indicate better performance, while lower scores indicate greater fall risk or postural deficits.
Measured: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Secondary outcomes (21)
Berg Balance Scale
The Berg Balance Scale (BBS) is a clinical tool used to assess static and dynamic balance through 14 functional tasks, such as standing, reaching, and turning.
Scoring: ranges from 0 (poor balance) to 56 (excellent balance); higher scores indicate better balance, while lower scores suggest increased risk of falls.
Measured: T0 (Baseline)
Berg Balance Scale
The Berg Balance Scale (BBS) is a clinical tool used to assess static and dynamic balance through 14 functional tasks, such as standing, reaching, and turning.
Scoring: ranges from 0 (poor balance) to 56 (excellent balance); higher scores indicate better balance, while lower scores suggest increased risk of falls.
Measured: T1 (4 weeks from the baseline - end of treatment period)
Berg Balance Scale
The Berg Balance Scale (BBS) is a clinical tool used to assess static and dynamic balance through 14 functional tasks, such as standing, reaching, and turning.
Scoring: ranges from 0 (poor balance) to 56 (excellent balance); higher scores indicate better balance, while lower scores suggest increased risk of falls.
Measured: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Performance Oriented Mobility Assessment
The Performance Oriented Mobility Assessment (POMA), also called the Tinetti Test, evaluates gait and balance to estimate fall risk in older adults. It includes two sections: balance (sitting, standing, turning) and gait (initiation, step length, symmetry).
Scoring: total ranges from 0 (highest fall risk / worst performance) to 28 (lowest fall risk / best performance); higher scores indicate better mobility and lower fall risk.
Measured: T0 (Baseline)
Performance Oriented Mobility Assessment
The Performance Oriented Mobility Assessment (POMA), also called the Tinetti Test, evaluates gait and balance to estimate fall risk in older adults. It includes two sections: balance (sitting, standing, turning) and gait (initiation, step length, symmetry).
Scoring: total ranges from 0 (highest fall risk / worst performance) to 28 (lowest fall risk / best performance); higher scores indicate better mobility and lower fall risk.
Measured: T1 (4 weeks from the baseline - end of treatment period)
Performance Oriented Mobility Assessment
The Performance Oriented Mobility Assessment (POMA), also called the Tinetti Test, evaluates gait and balance to estimate fall risk in older adults. It includes two sections: balance (sitting, standing, turning) and gait (initiation, step length, symmetry).
Scoring: total ranges from 0 (highest fall risk / worst performance) to 28 (lowest fall risk / best performance); higher scores indicate better mobility and lower fall risk.
Measured: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Modified Barthel Index
The Modified Barthel Index (MBI) is a scale that measures a person's independence in activities of daily living (ADLs), such as feeding, bathing, dressing, and mobility.
Scoring: ranges from 0 (completely dependent) to 100 (completely independent); higher scores indicate greater independence, lower scores indicate more severe dependency.
Measured: T0 (Baseline)
Modified Barthel Index
The Modified Barthel Index (MBI) is a scale that measures a person's independence in activities of daily living (ADLs), such as feeding, bathing, dressing, and mobility.
Scoring: ranges from 0 (completely dependent) to 100 (completely independent); higher scores indicate greater independence, lower scores indicate more severe dependency.
Measured: T1 (4 weeks from the baseline - end of treatment period)
Modified Barthel Index
The Modified Barthel Index (MBI) is a scale that measures a person's independence in activities of daily living (ADLs), such as feeding, bathing, dressing, and mobility.
Scoring: ranges from 0 (completely dependent) to 100 (completely independent); higher scores indicate greater independence, lower scores indicate more severe dependency.
Measured: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Stroke Specific Quality of Life Scale
The Stroke Specific Quality of Life Scale (SS-QOL) is a questionnaire designed to assess health-related quality of life in stroke survivors, covering physical, emotional, cognitive, and social domains.
Scoring: total scores typically range from 49 (worst quality of life) to 245 (best quality of life), with higher scores reflecting better perceived well-being and function.
Measured: T0 (Baseline)
Stroke Specific Quality of Life Scale
The Stroke Specific Quality of Life Scale (SS-QOL) is a questionnaire designed to assess health-related quality of life in stroke survivors, covering physical, emotional, cognitive, and social domains.
Scoring: total scores typically range from 49 (worst quality of life) to 245 (best quality of life), with higher scores reflecting better perceived well-being and function.
Measured: T1 (4 weeks from the baseline - end of treatment period)
Stroke Specific Quality of Life Scale
The Stroke Specific Quality of Life Scale (SS-QOL) is a questionnaire designed to assess health-related quality of life in stroke survivors, covering physical, emotional, cognitive, and social domains.
Scoring: total scores typically range from 49 (worst quality of life) to 245 (best quality of life), with higher scores reflecting better perceived well-being and function.
Measured: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
User Satisfaction Evaluation Questionnaire
The User Satisfaction Evaluation Questionnaire (USEQ) is a tool used to measure users' satisfaction with a device, system, or service, focusing on usability, comfort, and overall experience.
Scoring: typically ranges from 6 (lowest satisfaction) to 30 (highest satisfaction); higher scores indicate greater user satisfaction, while lower scores suggest issues or dissatisfaction.
Measured: T0 (Baseline)
User Satisfaction Evaluation Questionnaire
The User Satisfaction Evaluation Questionnaire (USEQ) is a tool used to measure users' satisfaction with a device, system, or service, focusing on usability, comfort, and overall experience.
Scoring: typically ranges from 6 (lowest satisfaction) to 30 (highest satisfaction); higher scores indicate greater user satisfaction, while lower scores suggest issues or dissatisfaction.
Measured: T1 (4 weeks from the baseline - end of treatment period)
User Satisfaction Evaluation Questionnaire
The User Satisfaction Evaluation Questionnaire (USEQ) is a tool used to measure users' satisfaction with a device, system, or service, focusing on usability, comfort, and overall experience.
Scoring: typically ranges from 6 (lowest satisfaction) to 30 (highest satisfaction); higher scores indicate greater user satisfaction, while lower scores suggest issues or dissatisfaction.
Measured: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Instrumental Gait Evaluation
The instrumental motor assessment will be performed using seven wearable inertial sensors (128 Hz, Opal, APDM, Portland, Oregon, USA), which operate with an internal battery and are completely wireless. Each inertial sensor contains a triaxial accelerometer, capable of measuring accelerations along its three axes, which will align with the body axes (antero-posterior, lateral-lateral, cranio-caudal), and a triaxial gyroscope to measure angular velocities around these same axes. The seven wearable sensors will be placed using elastic supports at the level of the lambdoid suture of the skull, trunk, sacrum (L4-L5), tibias, and wrists. Accelerations and angular velocities of the body segments of interest will be measured, and from these, various parameters will be extrapolated both in the time and frequency domains. The motor assessment using inertial sensors will be conducted during the execution of four motor tasks: The 10 Meter Walk Test, The Fukuda Stepping Test, The Figure-of-8 Walk
Measured: T0 (Baseline)
Instrumental Gait Evaluation
The instrumental motor assessment will be performed using seven wearable inertial sensors (128 Hz, Opal, APDM, Portland, Oregon, USA), which operate with an internal battery and are completely wireless. Each inertial sensor contains a triaxial accelerometer, capable of measuring accelerations along its three axes, which will align with the body axes (antero-posterior, lateral-lateral, cranio-caudal), and a triaxial gyroscope to measure angular velocities around these same axes. The seven wearable sensors will be placed using elastic supports at the level of the lambdoid suture of the skull, trunk, sacrum (L4-L5), tibias, and wrists. Accelerations and angular velocities of the body segments of interest will be measured, and from these, various parameters will be extrapolated both in the time and frequency domains. The motor assessment using inertial sensors will be conducted during the execution of four motor tasks: The 10 Meter Walk Test, The Fukuda Stepping Test, The Figure-of-8 Walk
Measured: T1 (4 weeks from the baseline - end of treatment period)
Instrumental Gait Evaluation
The instrumental motor assessment will be performed using seven wearable inertial sensors (128 Hz, Opal, APDM, Portland, Oregon, USA), which operate with an internal battery and are completely wireless. Each inertial sensor contains a triaxial accelerometer, capable of measuring accelerations along its three axes, which will align with the body axes (antero-posterior, lateral-lateral, cranio-caudal), and a triaxial gyroscope to measure angular velocities around these same axes. The seven wearable sensors will be placed using elastic supports at the level of the lambdoid suture of the skull, trunk, sacrum (L4-L5), tibias, and wrists. Accelerations and angular velocities of the body segments of interest will be measured, and from these, various parameters will be extrapolated both in the time and frequency domains. The motor assessment using inertial sensors will be conducted during the execution of four motor tasks: The 10 Meter Walk Test, The Fukuda Stepping Test, The Figure-of-8 Walk
Measured: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Instrumental assessment of vestibular function
The assessment of vestibular function will be performed using the Video Head Impulse Test, vHIT OtosuiteV®, GN Otometrics, Denmark. Data related to the gain of the vestibulo-ocular reflex (VOR) during the Head Impulse Paradigm (HIMP) and the Suppression Head Impulse Paradigm (SHIMP) will be considered.
Measured: T0 (Baseline)
Instrumental assessment of vestibular function
The assessment of vestibular function will be performed using the Video Head Impulse Test, vHIT OtosuiteV®, GN Otometrics, Denmark. Data related to the gain of the vestibulo-ocular reflex (VOR) during the Head Impulse Paradigm (HIMP) and the Suppression Head Impulse Paradigm (SHIMP) will be considered.
Measured: T1 (4 weeks from the baseline - end of treatment period)
Instrumental assessment of vestibular function
The assessment of vestibular function will be performed using the Video Head Impulse Test, vHIT OtosuiteV®, GN Otometrics, Denmark. Data related to the gain of the vestibulo-ocular reflex (VOR) during the Head Impulse Paradigm (HIMP) and the Suppression Head Impulse Paradigm (SHIMP) will be considered.
Measured: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start1 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacopo Piermaria, Principal investigator, Fondazione Santa Lucia IRCCSDiego Piatti, PT, Study chair, Fondazione Santa Lucia IRCCSSara De Angelis, MSc, Study chair, Fondazione Santa Lucia IRCCSRoberta Annicchiarico, MD, Study chair, Fondazione Santa Lucia IRCCSMatteo Marucci, PhD, Study chair, Department of Psychology, Sapienza University of Rome, Rome, Italy; Laboratory of Neuroscience and Applied Technology, Santa Lucia Foundation IRCCS, Rome, Italy.Viviana Betti, Prof., Study chair, Department of Psychology, Sapienza University of Rome, Rome, Italy; Laboratory of Neuroscience and Applied Technology, Santa Lucia Foundation IRCCS, Rome, Italy.Marco Tramontano, Prof, Study director, Department of Biomedical and Neuromotor Sciences, University of Bologna, 40138 Bologna, Italy.; Unit of Occupational Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780488
- Sponsor's protocol ID
- 171/SL/24
- Status last verified
- Oct 2025
- First submitted
- 13 Jan 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
LeMarshall SJ, Stevens LM, Ragg NP, Barnes L, Foster J, Canetti EFD. Virtual reality-based interventions for the rehabilitation of vestibular and balance impairments post-concussion: a scoping review. J Neuroeng Rehabil. 2023 Mar 3;20(1):31. doi: 10.1186/s12984-023-01145-4.
PubMed 36869367Mao Y, Chen P, Li L, Huang D. Virtual reality training improves balance function. Neural Regen Res. 2014 Sep 1;9(17):1628-34. doi: 10.4103/1673-5374.141795.
PubMed 25368651Martino Cinnera A, Verna V, Marucci M, Tavernese A, Magnotti L, Matano A, D'Acunto C, Paolucci S, Morone G, Betti V, Tramontano M. Immersive Virtual Reality for Treatment of Unilateral Spatial Neglect via Eye-Tracking Biofeedback: RCT Protocol and Usability Testing. Brain Sci. 2024 Mar 15;14(3):283. doi: 10.3390/brainsci14030283.
PubMed 38539671Tramontano M, Russo V, Spitoni GF, Ciancarelli I, Paolucci S, Manzari L, Morone G. Efficacy of Vestibular Rehabilitation in Patients With Neurologic Disorders: A Systematic Review. Arch Phys Med Rehabil. 2021 Jul;102(7):1379-1389. doi: 10.1016/j.apmr.2020.11.017. Epub 2020 Dec 28.
PubMed 33383031
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors
- ClinicalTrials.gov ID
- NCT06780488
- Acronym / sponsor ID
- 171/SL/24
- Conditions
- Stroke
- Keywords
- Stroke, Vestibular Rehabilitation, Virtual Reality, Balance, Gait, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Jan 2025 (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.
This pilot study aims to evaluate the effect of a specfic Virtual-Reality-Based rehabilitation training in patients with stroke. A total of 38 patients with stroke (more than 6 months from the acute event), recruited from the services of the Fondazione Santa Lucia IRCCS in Rome, will be included in the present study. Participants will be randomized into two groups: a Real group and a Sham group. Both groups will undergo a rehabilitation intervention using an immersive virtual reality system. The Real group will be exposed to scenarios containing specific stimuli for the visuo-vestibular system, while the Sham group will be exposed to the same scenarios but without specific stimuli. All participants in both groups will undergo 12 treatment sessions (three times a week), each lasting 20 minutes. All treatments will be conducted by physiotherapists specialized in neurological and vestibular rehabilitation. Patients will be assessed before the start of the treatment, at the end of the intervention, and one month after its completion, in order to evaluate the effects of the experimental training on balance and gait, and on the patient's perceived quality of life. Another aim will be to assess the user's satisfaction with the new proposed protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real | Experimental | Other: Real Visual-Vestibuar Rehabilitation |
| Control | Sham comparator | Other: Sham Rehabilitation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with a history of hemorrhagic or ischemic stroke (more than 6 months from the acute event)
- Patients aged between 18 and 80 years
- Absence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (MiniMentalState Evaluation > 24)
- Functional Ambulation Category ≥ 3
- Absence of associated orthopedic, visual, and/or neurological issues (clinically assessed) that may affect participation in the study
Key exclusion criteria (5 listed)
- Patients with stroke (less than 6 months from the acute event);
- Patients aged under 18 and over 80;
- Presence of associated orthopedic, visual, and/or neurological issues (clinically assessed) that may affect participation in the study;
- Presence of cognitive deficits that may interfere with the patient's ability to understand the exercise instructions (MiniMentalState Evaluation ≤ 24);
- Epilepsy.
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 |
|---|---|---|
| Real Visual-Vestibuar RehabilitationThe "Real Visual-Vestibular Rehabilitation" protocol will consist of specific exercises aimed at stimulating the visuo-vestibular function within immersive virtual reality environments replicating daily life situations. Patients will perform exercises in two types of contexts. In all exercises, patients will be free to move within a room large enough to complete the tasks. Walking during the exercises can also be performed with assistive devices, to make the context as close as possible to the patient's daily life. During the exercises, patients will be supervised by a physiotherapist specialized in neurological and vestibular rehabilitation.The protocol will last 20 minutes, with 10 minutes dedicated to each exercise. | Other | Real |
| Sham RehabilitationThe "Sham Vestibular Rehabilitation" protocol will involve the use of the same immersive virtual reality contexts and will aim to achieve the same objectives as the Real Visual-Vestibular Rehabilitation protocol, but without the "unexpected" stimuli. In both exercises, patients will be free to move within a room large enough to complete the tasks. Walking during the session can also be performed with assistive devices, to make the context as close as possible to the patient's daily life. During the exercises, patients will be supervised by a physiotherapist specialized in neurological and vestibular rehabilitation. The protocol will last 20 minutes, with 10 minutes dedicated to each exercise. | Other | Control |
Primary outcome
Mini-BESTest
Time frame: T0 (Baseline)
The Mini-BESTest is a clinical scale used to assess balance and fall risk, consisting of 14 items covering anticipatory, reactive, dynamic balance, and transfers. Scoring: ranges from 0 (worst balance) to 28 (best balance); higher scores indicate better performance, while lower scores indicate greater fall risk or postural deficits.
Mini-BESTest
Time frame: T1 (4 weeks from the baseline - end of treatment period)
The Mini-BESTest is a clinical scale used to assess balance and fall risk, consisting of 14 items covering anticipatory, reactive, dynamic balance, and transfers. Scoring: ranges from 0 (worst balance) to 28 (best balance); higher scores indicate better performance, while lower scores indicate greater fall risk or postural deficits.
Mini-BESTest
Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
The Mini-BESTest is a clinical scale used to assess balance and fall risk, consisting of 14 items covering anticipatory, reactive, dynamic balance, and transfers. Scoring: ranges from 0 (worst balance) to 28 (best balance); higher scores indicate better performance, while lower scores indicate greater fall risk or postural deficits.
21 secondary outcomes
Berg Balance Scale
Time frame: T0 (Baseline)
Berg Balance Scale
Time frame: T1 (4 weeks from the baseline - end of treatment period)
Berg Balance Scale
Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Performance Oriented Mobility Assessment
Time frame: T0 (Baseline)
Performance Oriented Mobility Assessment
Time frame: T1 (4 weeks from the baseline - end of treatment period)
Performance Oriented Mobility Assessment
Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Modified Barthel Index
Time frame: T0 (Baseline)
Modified Barthel Index
Time frame: T1 (4 weeks from the baseline - end of treatment period)
Modified Barthel Index
Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Stroke Specific Quality of Life Scale
Time frame: T0 (Baseline)
Stroke Specific Quality of Life Scale
Time frame: T1 (4 weeks from the baseline - end of treatment period)
Stroke Specific Quality of Life Scale
Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
User Satisfaction Evaluation Questionnaire
Time frame: T0 (Baseline)
User Satisfaction Evaluation Questionnaire
Time frame: T1 (4 weeks from the baseline - end of treatment period)
User Satisfaction Evaluation Questionnaire
Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Instrumental Gait Evaluation
Time frame: T0 (Baseline)
Instrumental Gait Evaluation
Time frame: T1 (4 weeks from the baseline - end of treatment period)
Instrumental Gait Evaluation
Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Instrumental assessment of vestibular function
Time frame: T0 (Baseline)
Instrumental assessment of vestibular function
Time frame: T1 (4 weeks from the baseline - end of treatment period)
Instrumental assessment of vestibular function
Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
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 23 Jan 2026.
- Background: PubMed 36869367LeMarshall SJ, Stevens LM, Ragg NP, Barnes L, Foster J, Canetti EFD. Virtual reality-based interventions for the rehabilitation of vestibular and balance impairments post-concussion: a scoping review. J Neuroeng Rehabil. 2023 Mar 3;20(1):31. doi: 10.1186/s12984-023-01145-4.
- Background: PubMed 25368651Mao Y, Chen P, Li L, Huang D. Virtual reality training improves balance function. Neural Regen Res. 2014 Sep 1;9(17):1628-34. doi: 10.4103/1673-5374.141795.
- Background: PubMed 38539671Martino Cinnera A, Verna V, Marucci M, Tavernese A, Magnotti L, Matano A, D'Acunto C, Paolucci S, Morone G, Betti V, Tramontano M. Immersive Virtual Reality for Treatment of Unilateral Spatial Neglect via Eye-Tracking Biofeedback: RCT Protocol and Usability Testing. Brain Sci. 2024 Mar 15;14(3):283. doi: 10.3390/brainsci14030283.
- Background: PubMed 33383031Tramontano M, Russo V, Spitoni GF, Ciancarelli I, Paolucci S, Manzari L, Morone G. Efficacy of Vestibular Rehabilitation in Patients With Neurologic Disorders: A Systematic Review. Arch Phys Med Rehabil. 2021 Jul;102(7):1379-1389. doi: 10.1016/j.apmr.2020.11.017. Epub 2020 Dec 28.
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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.
Jacopo Piermaria principal investigator
Fondazione Santa Lucia IRCCS
Diego Piatti, PT study chair
Fondazione Santa Lucia IRCCS
Sara De Angelis, MSc study chair
Fondazione Santa Lucia IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Visual-Vestibuar Rehabilitation in people with Stroke, run by I.R.C.C.S. Fondazione Santa Lucia 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 5 inclusion and 5 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 23 Jan 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. Some participants in this study may receive a placebo. 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 Sara De Angelis, MSc (00390651501772, s.deangelis@hasantalucia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-BESTest (time frame: T0 (Baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06780488, which also lists 4 linked publications.
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 23 Jan 2026.