Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07096700

VR and Orthoses for Rehabilitation in Multiple Sclerosis

Led by Azienda Usl di Bologna · Updated on 2026-03-30

12

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

VR and Orthoses for Rehabilitation in Multiple Sclerosis

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of multiple sclerosis
  • Age between 18 and 65 years
  • Both sexes
  • Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) score above 100
  • Expanded Disability Status Scale (EDSS) between 3 and 6 inclusive
  • Berg Balance Scale (BBS) score of 46 or higher
  • Indicated for use of the Exoband orthosis for gait support
  • Modified Fatigue Impact Scale (MFIS) physical subscale score of 20 or less
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Severe or current visual or auditory impairments
  • Multiple sclerosis relapses within the last 3 months
  • Severe anxiety or depression
  • Severe spasticity in lower limbs or fixed distal tendon contractures
  • Motion sickness symptoms triggered by virtual reality

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

Bologna, Bologna, Italy, 40139

Not Yet Recruiting

2

IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

Bologna, BO, Italy, 40139

Actively Recruiting

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Research Team

K

Kevin Marcaccini

CONTACT

L

Loredana Sabattini

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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VR and Orthoses for Rehabilitation in Multiple Sclerosis | DecenTrialz