Multiple Sclerosis (MS) Clinical Trials

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
RECRUITING
Bologna
IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
NOT_YET_RECRUITING
Bologna
Contact Information
Primary
Kevin Marcaccini
kevin.marcaccini@ausl.bologna.it
+390514966403
Backup
Loredana Sabattini
loredana.sabattini@isnb.it
+3905174966217
Time Frame
Start Date: 2026-03-02
Estimated Completion Date: 2026-09
Participants
Target number of participants: 12
Treatments
Other: VR - Multiple Sclerosis
Twelve adults with multiple sclerosis who require a walking brace to support ambulation and are compatible with Virtual Reality
Related Therapeutic Areas
Sponsors
Leads: Azienda Usl di Bologna

This content was sourced from clinicaltrials.gov