VR and Orthoses for Rehabilitation in Multiple Sclerosis

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Score of the standardized tests and gait parameters — From T1 (day 2) to T2 (day 9)
  This outcome assesses the adaptation to the walking brace during ambulation. Gait performance across different sessions will be analyzed and compared to observe improvement between T1 and T2. Participant satisfaction with the use of VR will be considered met if individuals can successfully engage with and complete the sessions using the system.

Trial sites (2)

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