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NCT Number: NCT06780488

Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Santa Lucia IRCCS

Roma, RM, 00142, Italy

Location status: Recruiting

Location contact

Sara De Angelis, MSc

CONTACT

[email protected]

00390651501772

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Real Visual-Vestibuar Rehabilitation

Other

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 Rehabilitation

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Berg Balance Scale

    Time frame: T0 (Baseline)

    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.

  2. Berg Balance Scale

    Time frame: T1 (4 weeks from the baseline - end of treatment period)

    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.

  3. Berg Balance Scale

    Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)

    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.

  4. Performance Oriented Mobility Assessment

    Time frame: T0 (Baseline)

    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.

  5. Performance Oriented Mobility Assessment

    Time frame: T1 (4 weeks from the baseline - end of treatment period)

    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.

  6. Performance Oriented Mobility Assessment

    Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)

    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.

  7. Modified Barthel Index

    Time frame: T0 (Baseline)

    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.

  8. Modified Barthel Index

    Time frame: T1 (4 weeks from the baseline - end of treatment period)

    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.

  9. Modified Barthel Index

    Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)

    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.

  10. Stroke Specific Quality of Life Scale

    Time frame: T0 (Baseline)

    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.

  11. Stroke Specific Quality of Life Scale

    Time frame: T1 (4 weeks from the baseline - end of treatment period)

    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.

  12. Stroke Specific Quality of Life Scale

    Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)

    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.

  13. User Satisfaction Evaluation Questionnaire

    Time frame: T0 (Baseline)

    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.

  14. User Satisfaction Evaluation Questionnaire

    Time frame: T1 (4 weeks from the baseline - end of treatment period)

    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.

  15. User Satisfaction Evaluation Questionnaire

    Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)

    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.

  16. Instrumental Gait Evaluation

    Time frame: T0 (Baseline)

    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

  17. Instrumental Gait Evaluation

    Time frame: T1 (4 weeks from the baseline - end of treatment period)

    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

  18. Instrumental Gait Evaluation

    Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)

    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

  19. Instrumental assessment of vestibular function

    Time frame: T0 (Baseline)

    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.

  20. Instrumental assessment of vestibular function

    Time frame: T1 (4 weeks from the baseline - end of treatment period)

    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.

  21. Instrumental assessment of vestibular function

    Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara De Angelis, MSc

CONTACT

[email protected]

00390651501772

Sponsors and collaborators

Lead sponsor

I.R.C.C.S. Fondazione Santa Lucia

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 17, 2025
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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