Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06780488

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

Led by I.R.C.C.S. Fondazione Santa Lucia · Updated on 2026-01-23

38

Participants Needed

1

Research Sites

139 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of hemorrhagic or ischemic stroke more than 6 months ago
  • Age between 18 and 80 years
  • No cognitive deficits interfering with understanding exercise instructions (MiniMentalState Evaluation > 24)
  • Functional Ambulation Category of 3 or higher
  • No orthopedic, visual, or neurological conditions affecting study participation (clinically assessed)
Not Eligible

You will not qualify if you...

  • Stroke occurred less than 6 months ago
  • Age under 18 or over 80 years
  • Orthopedic, visual, or neurological conditions affecting study participation (clinically assessed)
  • Cognitive deficits interfering with understanding exercise instructions (MiniMentalState Evaluation ≤ 24)
  • Epilepsy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione Santa Lucia IRCCS

Roma, RM, Italy, 00142

Actively Recruiting

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Research Team

S

Sara De Angelis, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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