Virtual reality plus a walking brace to improve walking in people with MS
Official title: Virtual Reality for Gait Training in Multiple Sclerosis (VIRTUE): an Interventional Feasibility Study
Run by Azienda Usl di Bologna · NCT07096700 · Data updated 2026-11-12
This trial is testing whether combining virtual reality, wearable sensors, and a passive walking brace can help adults with multiple sclerosis walk more naturally and provide better gait data for clinicians.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Azienda Usl di Bologna Government |
| Locations | 2 sites (Bologna, Bologna and 1 other locations) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | June 2026 |
| Study ends | September 2026 |
| Registry record updated | March 30, 2026 |
| Trial ID | NCT07096700 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with confirmed multiple sclerosis, moderate gait disability (EDSS 3–6), adequate cognition and balance, an indication for the Exoband orthosis, and no recent relapse are the intended participants.
✕Probably not a fit
People with severe visual or auditory impairment, severe lower-limb spasticity or fixed contractures, recent relapses, severe anxiety/depression, or VR-induced motion sickness are unlikely to benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This non-drug interventional project uses a head-mounted virtual reality system and wearable inertial sensors while participants wear a passive Exoband orthosis to recreate everyday walking tasks in a controlled clinic environment. Standardized gait tasks embedded in realistic virtual scenes are used to reduce the artificial influence of typical clinical assessments and to observe orthosis performance in situations that resemble daily life. Objective gait metrics from the sensors will be collected alongside clinical measures to guide orthosis adaptation and training. The protocol targets people with moderate disability and sufficient cognition and balance to complete the VR gait sessions.
Why it matters
Potential benefit: If successful, the approach could help clinicians better tailor orthoses and improve real-world walking performance and comfort for people with MS.
How similar studies have gone: Previous work using VR and wearable sensors for gait in neurological populations has shown promise, but combining these technologies specifically to guide orthosis adaptation is relatively novel and less tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of multiple sclerosis * Age between 18 and 65 years * Both sexes * Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS \> 100) * Expanded Disability Status Scale (EDSS between 3 and 6 inclusive) * Berg Balance Scale (BBS ≥ 46) * Indication for the use of the Exoband orthosis for gait assistance * Modified Fatigue Impact Scale (MFIS) physical subscale ≤ 20 * Signed informed consent Exclusion Criteria: * Presence of severe or current visual or auditory impairments * Relapses within the last 3 months * Presence of severe anxiety or depression * Severe spasticity patterns in the lower limbs or fixed distal tendon contractures * Presence of motion sickness symptoms induced by virtual reality (VR)
Where it's running
-
IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
Bologna, Bo, Italy Recruiting -
IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
Bologna, Bologna, Italy Not yet recruiting
Study contacts
- Principal investigator: Loredana Sabattini — IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
- Study coordinator: Kevin Marcaccini
- Email: kevin.marcaccini@ausl.bologna.it
- Phone: +390514966403
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Treadmill-based virtual reality walking training for MS patients
This study tests whether a treadmill with virtual reality and smart socks can help people with multiple sclerosis walk better and feel safer in daily life.
-
Virtual Reality and Mental Practice to Improve Balance and Walking in Relapsing MS
This study tests whether virtual reality training or mental practice can improve balance and walking in people with relapsing–remitting multiple sclerosis.
-
REAL-MS: A Look at Autologous Stem Cell Transplant vs High-Efficacy MS Therapies in Real-World Care
This study tests how AHSCT compares to high-efficacy MS medicines in adults treated in routine clinical care.
-
Tolebrutinib in real-world MS care for patients treated by clinicians
This real-world study sees how tolebrutinib is used for multiple sclerosis patients and what outcomes look like in everyday practice.
-
Pilates via live video vs. prerecorded videos for people with multiple sclerosis
This study tests whether live, coach-led Pilates sessions through video calls are more beneficial than prerecorded Pilates videos for adults with MS.
-
Cooling During Inpatient Rehab for People with MS
This trial tests whether wearing a cooling vest during intensive training can reduce fatigue and improve walking, strength, balance, and cognition in people with multiple sclerosis during a 3-week inpatient rehab stay.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.