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

Обзор

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Berg Balance Scale [Срок оценки: T0 (Baseline)]
• Berg Balance Scale [Срок оценки: T1 (4 weeks from the baseline - end of treatment period)]
• Berg Balance Scale [Срок оценки: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)]
• Performance Oriented Mobility Assessment [Срок оценки: T0 (Baseline)]
• Performance Oriented Mobility Assessment [Срок оценки: T1 (4 weeks from the baseline - end of treatment period)]
• Performance Oriented Mobility Assessment [Срок оценки: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)]
• Modified Barthel Index [Срок оценки: T0 (Baseline)]
• Modified Barthel Index [Срок оценки: T1 (4 weeks from the baseline - end of treatment period)]
• Modified Barthel Index [Срок оценки: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)]
• Stroke Specific Quality of Life Scale [Срок оценки: T0 (Baseline)]
• Stroke Specific Quality of Life Scale [Срок оценки: T1 (4 weeks from the baseline - end of treatment period)]
• Stroke Specific Quality of Life Scale [Срок оценки: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Fondazione Santa Lucia IRCCS — Roma

Публикации

• 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

Идентификаторы

NCT: NCT06780488 · 171/SL/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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