VR and Orthoses for Rehabilitation in Multiple Sclerosis (NCT07096700) | Clinical Trial Compass
RecruitingNot Applicable
VR and Orthoses for Rehabilitation in Multiple Sclerosis
Italy12 participantsStarted 2026-03-02
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Presence of motion sickness symptoms induced by virtual reality (VR)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Score of the standardized tests and gait parameters