Clinical trial NCT06780488: Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors
Official title: Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Vestibular Rehabilitation
Virtual Reality
Balance
Gait
Quality of Life
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Mini-BESTest
timeFrame: T0 (Baseline)
measure: Mini-BESTest
timeFrame: T1 (4 weeks from the baseline - end of treatment period)
measure: Mini-BESTest
timeFrame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: T0 (Baseline)
measure: Berg Balance Scale
timeFrame: T1 (4 weeks from the baseline - end of treatment period)
measure: Berg Balance Scale
timeFrame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
measure: Performance Oriented Mobility Assessment
timeFrame: T0 (Baseline)
measure: Performance Oriented Mobility Assessment
timeFrame: T1 (4 weeks from the baseline - end of treatment period)
measure: Performance Oriented Mobility Assessment
timeFrame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
measure: Modified Barthel Index
timeFrame: T0 (Baseline)
measure: Modified Barthel Index
timeFrame: T1 (4 weeks from the baseline - end of treatment period)
measure: Modified Barthel Index
timeFrame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
measure: Stroke Specific Quality of Life Scale
timeFrame: T0 (Baseline)
measure: Stroke Specific Quality of Life Scale
timeFrame: T1 (4 weeks from the baseline - end of treatment period)
measure: Stroke Specific Quality of Life Scale
timeFrame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
measure: User Satisfaction Evaluation Questionnaire
timeFrame: T0 (Baseline)
measure: User Satisfaction Evaluation Questionnaire
timeFrame: T1 (4 weeks from the baseline - end of treatment period)
measure: User Satisfaction Evaluation Questionnaire
timeFrame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
measure: Instrumental Gait Evaluation
timeFrame: T0 (Baseline)
measure: Instrumental Gait Evaluation
timeFrame: T1 (4 weeks from the baseline - end of treatment period)
measure: Instrumental Gait Evaluation
timeFrame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
measure: Instrumental assessment of vestibular function
timeFrame: T0 (Baseline)
measure: Instrumental assessment of vestibular function
timeFrame: T1 (4 weeks from the baseline - end of treatment period)
measure: Instrumental assessment of vestibular function
timeFrame: T2 ( 4 weeks and 1 month from the baseline - 1 month follow up)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Santa Lucia IRCCS
state: RM
Study officials:
affiliation: Fondazione Santa Lucia IRCCS
name: Jacopo Piermaria
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Santa Lucia IRCCS
name: Diego Piatti, PT
role: STUDY_CHAIR
affiliation: Fondazione Santa Lucia IRCCS
name: Sara De Angelis, MSc
role: STUDY_CHAIR
affiliation: Fondazione Santa Lucia IRCCS
name: Roberta Annicchiarico, MD
role: STUDY_CHAIR
affiliation: Department of Psychology, Sapienza University of Rome, Rome, Italy; Laboratory of Neuroscience and Applied Technology, Santa Lucia Foundation IRCCS, Rome, Italy.
name: Matteo Marucci, PhD
role: STUDY_CHAIR
affiliation: Department of Psychology, Sapienza University of Rome, Rome, Italy; Laboratory of Neuroscience and Applied Technology, Santa Lucia Foundation IRCCS, Rome, Italy.
name: Viviana Betti, Prof.
role: STUDY_CHAIR
affiliation: 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
name: Marco Tramontano, Prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.