Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Mini-BESTest
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control
Intervention: Sham Rehabilitation (Other)
Real
Intervention: Real Visual-Vestibuar Rehabilitation (Other)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Instrumental Gait Evaluation(T2 ( 4 weeks and 1 month from the baseline - 1 month follow up))
- Instrumental assessment of vestibular function(T2 ( 4 weeks and 1 month from the baseline - 1 month follow up))
- Berg Balance Scale(T2 ( 4 weeks and 1 month from the baseline - 1 month follow up))
- Performance Oriented Mobility Assessment(T2 ( 4 weeks and 1 month from the baseline - 1 month follow up))
- Modified Barthel Index(T2 ( 4 weeks and 1 month from the baseline - 1 month follow up))
- Stroke Specific Quality of Life Scale(T2 ( 4 weeks and 1 month from the baseline - 1 month follow up))
- User Satisfaction Evaluation Questionnaire(T2 ( 4 weeks and 1 month from the baseline - 1 month follow up))
- Berg Balance Scale(T0 (Baseline))
- Berg Balance Scale(T1 (4 weeks from the baseline - end of treatment period))
- Performance Oriented Mobility Assessment(T0 (Baseline))
- Modified Barthel Index(T0 (Baseline))
- Performance Oriented Mobility Assessment(T1 (4 weeks from the baseline - end of treatment period))
- Modified Barthel Index(T1 (4 weeks from the baseline - end of treatment period))
- Stroke Specific Quality of Life Scale(T0 (Baseline))
- Stroke Specific Quality of Life Scale(T1 (4 weeks from the baseline - end of treatment period))
- User Satisfaction Evaluation Questionnaire(T0 (Baseline))
- User Satisfaction Evaluation Questionnaire(T1 (4 weeks from the baseline - end of treatment period))
- Instrumental Gait Evaluation(T0 (Baseline))
- Instrumental Gait Evaluation(T1 (4 weeks from the baseline - end of treatment period))
- Instrumental assessment of vestibular function(T0 (Baseline))
- Instrumental assessment of vestibular function(T1 (4 weeks from the baseline - end of treatment period))