Virtual reality plus a walking brace to improve walking in people with MS
Virtual Reality for Gait Training in Multiple Sclerosis (VIRTUE): an Interventional Feasibility Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Azienda Usl di Bologna Government |
| Locations | 2 sites (Bologna, Bologna and 1 other locations) |
| Trial ID | NCT07096700 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna, Bologna and 1 other locations
- IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna — Bologna, Bologna, Italy (Not_yet_recruiting)
- IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna — Bologna, Bo, Italy (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
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.