VR and Orthoses for Rehabilitation in Multiple Sclerosis
Recruiting · NCT07096700 · Interventional (participants receive a specific treatment) · Lead sponsor: Azienda Usl di Bologna
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
2 locations listed.
- IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna - Bologna, BO, Italy
- IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna - Bologna, Bologna, Italy