VR and Orthoses for Rehabilitation in Multiple Sclerosis
Virtual Reality for Gait Training in Multiple Sclerosis (VIRTUE): an Interventional Feasibility Study
Azienda Usl di Bologna
12 participants
Mar 2, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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 Criteria5
- 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)
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Interventions
The study implements the use of VR and wearable sensors to enhance gait analysis in clinical practice. Participants will take part in two outpatient sessions (T1 and T2) involving the use of VR and wearable sensors, during which they will be asked to complete standardized gait tests and questionnaires. These two sessions will be separated by a one-week home phase (Th), during which participants will wear the walking brace in their daily activities and their gait and physiological data will be recorded by wearable sensors. A final session (T3), conducted without VR, will be scheduled two months later to assess the long-term retention of the intervention effects.
Locations(2)
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NCT07096700