VR and Orthoses for Rehabilitation in Multiple Sclerosis

NCT ID: NCT07096700

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-05-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

VR - Multiple Sclerosis

Twelve adults with multiple sclerosis who require a walking brace to support ambulation and are compatible with Virtual Reality

Group Type: OTHER

VR and walking brace-based gait rehabilitation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Usl di Bologna

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Loredana Sabattini

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

Locations

IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

Bologna, Bologna, Italy

Countries

Italy

Central Contacts

Kevin Marcaccini

Role: CONTACT

kevin.marcaccini@ausl.bologna.it

+390514966403

Loredana Sabattini

Role: CONTACT

loredana.sabattini@isnb.it

+3905174966217

Facility Contacts

Kevin Marcaccini

Role: primary

kevin.marcaccini@ausl.bologna.it

+390514966403

Loredana Sabattini

Role: backup

loredana.sabattini@isnb.it

+3905174966217

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 33975555 (View on PubMed)

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Reference Type: BACKGROUND

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Other Identifiers

VIRTUE

Identifier Type: -

Identifier Source: org_study_id