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

NCT06780488 | Recruiting

• 1 other identifier: 171/SL/24
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Vestibular Rehabilitation; Virtual Reality; Balance; Gait; Quality of Life

Outcome Measures

Primary Outcomes (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.

  T0 (Baseline)

• 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.

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

• 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.

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

Secondary Outcomes (21)

• Berg Balance Scale

  T0 (Baseline)

• Berg Balance Scale

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

• Berg Balance Scale

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

• Performance Oriented Mobility Assessment

  T0 (Baseline)

• Performance Oriented Mobility Assessment

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

Study Arms (2)

Real

EXPERIMENTAL

Other: Real Visual-Vestibuar Rehabilitation

Control

SHAM COMPARATOR

Other: Sham Rehabilitation

Interventions

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.

Real

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.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

Fondazione Santa Lucia IRCCS

Roma, RM, 00142, Italy

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jacopo Piermaria

  Fondazione Santa Lucia IRCCS

  PRINCIPAL INVESTIGATOR

• Diego Piatti, PT

  Fondazione Santa Lucia IRCCS

  STUDY CHAIR

• Sara De Angelis, MSc

  Fondazione Santa Lucia IRCCS

  STUDY CHAIR

• Roberta Annicchiarico, MD

  Fondazione Santa Lucia IRCCS

  STUDY CHAIR

• Matteo Marucci, PhD

  Department of Psychology, Sapienza University of Rome, Rome, Italy; Laboratory of Neuroscience and Applied Technology, Santa Lucia Foundation IRCCS, Rome, Italy.

  STUDY CHAIR

• Viviana Betti, Prof.

  Department of Psychology, Sapienza University of Rome, Rome, Italy; Laboratory of Neuroscience and Applied Technology, Santa Lucia Foundation IRCCS, Rome, Italy.

  STUDY CHAIR

• Marco Tramontano, Prof

  Department of Biomedical and Neuromotor Sciences, University of Bologna, 40138 Bologna, Italy.; Unit of Occupational Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy

  STUDY DIRECTOR

Central Study Contacts

Sara De Angelis, MSc

CONTACT

00390651501772; s.deangelis@hasantalucia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2025-10

Locations

IT (1)