VR and Orthoses for Rehabilitation in Multiple Sclerosis

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

RecruitingNot a drug-phase studyMS (type not specified)NCT07096700

What it found

Still running

No result yet.

What was tested

Treatment tested

  • VR and walking brace-based gait rehabilitation

What it measured

Main measures

  • Score of the standardized tests and gait parameters

    From T1 (day 2) to T2 (day 9)

    MRI lesionsWalking and mobilityQuality of life (reported by participants)

Other measures (13)

  • NASA-TLX (NASA Task Load Index) questionnaire score

    T1 (day 2); T2 (day 10); T3 (day 70)

    Physical function

  • MSAQ (Motion Sickness Assessment Questionnaire) questionnaire score

    T0 (day 1); T1 (day 2); T2 (day 10)

  • IPQ (iGroupPresence Questionnaire) questionnaire score

    T1 (day 2); T2 (day 10)

  • MusiQoL (Multiple Sclerosis International Quality of Life) questionnaire score

    T1 (day 2), T2 (day 10), T3 (day 70)

    Quality of life (reported by participants)

  • BBS (Berg Balance Scale) questionnaire score

    T1 (day 2); T2 (day 10); T3 (day 70)

    Walking and mobility

  • EDSS (Expanded Disability Status Scale) questionnaire score

    T0 (day 1)

    Disability progressionThinking and memoryBladder, bowel and sexual function

  • MFIS (Modified Fatigue Impact Scale) questionnaire score

    T0 (day 1); T1 (day 2); Th (day 3-9); T2 (day 10); T3 (day 70)

    Thinking and memoryFatigue

  • MSWS-12 (Twelve-Item Multiple Sclerosis Walking Scale) questionnaire score

    T1 (day 2); T2 (day 10); T3 (day 70)

    Walking and mobility

  • Timed 25-Foot Walk Test (T25FW) test score

    T1 (day 2); T2 (day 10); T3 (day 70)

    Disability progressionWalking and mobility

  • 2MWT (2-Minute Walk Test) test score

    T1 (day 2); T2 (day 10); T3 (day 70)

    Walking and mobility

Who could take part

MS (type not specified) · 18 to 65 · EDSS 3 to 6

Show the full criteria

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)

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Mar 2026

    2. Main results due

      Jun 2026

    3. Finished

      Sept 2026

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