NCT07096700

VR and Orthoses for Rehabilitation in Multiple Sclerosis

Virtual Reality for Gait Training in Multiple Sclerosis (VIRTUE): an Interventional Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Azienda Usl di Bologna · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with multiple sclerosis (MS) often experience significant gait impairments that impact their autonomy and overall quality of life. One of the primary rehabilitation strategies involves the use of walking braces. While these orthotic devices can support ambulation, their effective integration into daily life typically requires a period of adaptation and specific training. Traditionally, gait training and orthosis prescription occur in clinical settings, which may not fully reflect the real-world challenges that patients encounter. Moreover, current clinical assessments rely primarily on subjective observations and standardized scales, which may lack the sensitivity and objectivity needed to capture the full complexity of gait performance. virtual reality (VR) offers a promising opportunity to simulate realistic walking environments in a controlled and safe setting, such as an outpatient clinic, potentially enhancing the outcomes of gait rehabilitation. Another promising technology in this domain is the use of wearable inertial sensors, which have been shown to effectively measure gait and postural parameters in people with MS. A further challenge associated with the use of orthotic devices is the physical and psychological stress they may cause, which can lead patients to discontinue their use. To evaluate such discomfort more objectively, recent studies have explored the use of physiological signal analysis and machine learning (ML) algorithms as an alternative or complement to self-reported questionnaires. The integration of VR with wearable inertial and physiological sensors may allow for a more comprehensive and objective assessment of a patient's adaptation to walking braces. However, no validated system currently exists that combines these technologies for gait assessment and training with passive orthoses in people with MS. The VIRTUE study aims to address this gap by developing and evaluating a VR-based platform (VIRTUE4MS) that replicates real-life scenarios, such as navigating through a museum, park, or grocery store, and enables standardized gait assessments within immersive environments. The system will employ both inertial and physiological wearable sensors to gather data on gait dynamics and user experience, ultimately supporting clinical decision-making regarding orthotic use. In this study, 12 patients with MS will perform walking and balance tasks over three sessions (T1, T2, T3), both with and without the Exoband brace, in VR and real-world conditions. Ultimately, this study seeks to explore an innovative, technology-supported approach to orthosis assessment and gait training that could complement traditional clinical tools and contribute to more effective, personalized rehabilitation strategies for individuals with MS.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	VR and walking brace-based gait rehabilitation	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.

Timeline

• Start date: 2026-03-02
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2025-07-31
• Last updated: 2026-03-30

Locations

2 sites across 1 country: Italy