NCT07096700Recruiting
VR and Orthoses for Rehabilitation in Multiple Sclerosis
Virtual Reality for Gait Training in Multiple Sclerosis (VIRTUE): an Interventional Feasibility Study
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
This non-drug, non-medical device, interventional study explores the feasibility of integrating virtual reality (VR) with wearable sensors to support gait training using a passive orthosis in individuals with multiple sclerosis (MS). The aim is to determine whether this approach can enhance clinical gait assessment and facilitate orthosis adaptation by replicating real-life scenarios within a safe and controlled environment. The virtual environment, accessed through a head-mounted display, will be delivered via a custom simulator incorporating standardized gait tasks embedded in everyday settings. This system is designed to minimize the artificial influence of clinical settings on walking performance, while providing clinicians with objective gait data for more comprehensive evaluation.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 24 Jul 2025
- Start date
- 2 Mar 2026
- Primary completion date
- Jun 2026
- Lead sponsor
- Azienda Usl di Bologna
- Diseases
- Multiple sclerosis
- NCT number
- NCT07096700
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 2 Mar 2026 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Not yet recruiting |
Related publications
- Interventional Feasibility Study Investigating Virtual Reality-Based Gait Assessment With Orthoses in People With Multiple Sclerosis: A Study Protocol.Clin Transl Sci · 2026 · PMID 42717397
This page is information, not medical advice. Discuss any trial with your doctor.