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

Overview

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.

Interventions

• Other Real Visual-Vestibuar Rehabilitation
  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 p
• Other Sham Rehabilitation
  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

Primary outcome measures

• Mini-BESTest [Time frame: T0 (Baseline)]
• Mini-BESTest [Time frame: T1 (4 weeks from the baseline - end of treatment period)]
• Mini-BESTest [Time frame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)]

Secondary outcome measures (12)

• 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• Fondazione Santa Lucia IRCCS — Roma

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. PMID 36869367
• Mao 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. PMID 25368651
• Martino 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. PMID 38539671
• Tramontano 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. PMID 33383031

Identifiers

NCT: NCT06780488 · 171/SL/24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗