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

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 12 participants

Interventions

• 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 re

Primary Outcomes

• Score of the standardized tests and gait parameters (From T1 (day 2) to T2 (day 9))

Secondary Outcomes

• NASA-TLX (NASA Task Load Index) questionnaire score (T1 (day 2); T2 (day 10); T3 (day 70))
• MSAQ (Motion Sickness Assessment Questionnaire) questionnaire score (T0 (day 1); T1 (day 2); T2 (day 10))
• IPQ (iGroupPresence Questionnaire) questionnaire score (T1 (day 2); T2 (day 10))
• MusiQoL (Multiple Sclerosis International Quality of Life) questionnaire score (T1 (day 2), T2 (day 10), T3 (day 70))
• BBS (Berg Balance Scale) questionnaire score (T1 (day 2); T2 (day 10); T3 (day 70))

Trial Locations

• IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna, Bologna, Bologna, Italy
• IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna, Bologna, BO, Italy

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