Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorI.R.C.C.S. Fondazione Santa Lucia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Real Visual-Vestibuar Rehabilitation
Other interventionThe "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 interventionThe "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.
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: RealExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
T0 (Baseline)2
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.
Time frame
T1 (4 weeks from the baseline - end of treatment period)3
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.
Time frame
T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)Secondary outcomes
1
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.
Time frame
T0 (Baseline)2
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.
Time frame
T1 (4 weeks from the baseline - end of treatment period)3
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.
Time frame
T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)4
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.
Time frame
T0 (Baseline)Sponsors and contacts
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Source ClinicalTrials.gov