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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Virtual Reality Based Rehabilitation After Ischemic Stroke

NCT06401564

Ischemic Stroke

RECRUITING NA

Virtual Reality Rehabilitation in Patients With Acquired Brain Injury

NCT03402360

Acquired Brain Injury

UNKNOWN NA

Virtual Reality Training Affects on Motor Functions and Mental Health in Stroke Patients

NCT04681235

Stroke Motor Disorders Affective Symptoms +1 more

COMPLETED NA

Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Stroke Rehabilitation Setting

NCT06053970

Stroke Rehabilitation Postural Equilibrium

UNKNOWN NA

Immersive Virtual Reality in Post Stroke

NCT04379687

Balance Stroke Physical Therapy +1 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Real

Group Type EXPERIMENTAL

Real Visual-Vestibuar Rehabilitation

Intervention Type 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.

Control

Group Type SHAM_COMPARATOR

Sham Rehabilitation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 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.

Intervention Type 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 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jacopo Piermaria

Role: PRINCIPAL_INVESTIGATOR

Fondazione Santa Lucia IRCCS

Diego Piatti, PT

Role: STUDY_CHAIR

Fondazione Santa Lucia IRCCS

Sara De Angelis, MSc

Role: STUDY_CHAIR

Fondazione Santa Lucia IRCCS

Roberta Annicchiarico, MD

Role: STUDY_CHAIR

Fondazione Santa Lucia IRCCS

Matteo Marucci, PhD

Role: STUDY_CHAIR

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

Viviana Betti, Prof.

Role: STUDY_CHAIR

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

Marco Tramontano, Prof

Role: STUDY_DIRECTOR

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