VR and Orthoses for Rehabilitation in Multiple Sclerosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAzienda Usl di Bologna

About this trial

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 criteria

Qualifiers

Confirmed diagnosis of multiple sclerosis

Age between 18 and 65 years

Both sexes

Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS > 100)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • VR and walking brace-based gait rehabilitation

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators