Virtual reality rehabilitation for balance and gait improvement in stroke survivors
Visuo-Vestibular VR-based Stimulation Effects on Balance and Gait in Stroke Survivors
This study is testing if a virtual reality rehabilitation program can help stroke survivors improve their balance and walking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | I.R.C.C.S. Fondazione Santa Lucia Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT06780488 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effects of a virtual reality-based rehabilitation program on balance and gait in stroke survivors. A total of 38 patients, more than six months post-stroke, will be randomized into two groups: one receiving real visuo-vestibular stimuli and the other receiving sham treatment. Both groups will participate in 12 sessions of immersive virtual reality training, guided by specialized physiotherapists. Assessments will be conducted before and after the intervention to measure outcomes.
Who should consider this trial
Good fit: Ideal candidates are stroke survivors aged 18 to 80, more than six months post-stroke, with no cognitive deficits or other conditions affecting participation.
Not a fit: Patients who are less than six months post-stroke, under 18 or over 80, or have cognitive deficits or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance balance and gait recovery in stroke survivors, improving their quality of life.
How similar studies have performed: Other studies have shown promising results using virtual reality for rehabilitation, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma, RM
- Fondazione Santa Lucia IRCCS — Roma, Rm, Italy (Recruiting)
Study contacts
- Principal investigator: Jacopo Piermaria — Fondazione Santa Lucia IRCCS
- Study coordinator: Sara De Angelis, MSc
- Email: s.deangelis@hasantalucia.it
- Phone: 00390651501772
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.