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Multiple SclerosisVIRTUENCT07096700

VR and Orthoses for Rehabilitation in Multiple Sclerosis

A study testing VR and walking brace-based gait rehabilitation in people with Multiple Sclerosis, run by Azienda Usl di Bologna at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
VR and walking brace-based gait rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesItaly
Study dates
2 Mar 2026to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • Indication for the use of the Exoband orthosis for gait assistance
  • Modified Fatigue Impact Scale (MFIS) physical subscale ≤ 20
  • Signed informed consent

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Italy2 sites, 2 recruiting
  • IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

    Bologna, Bologna, 40139

    Kevin Marcaccini, +390514966403, kevin.marcaccini@ausl.bologna.it

    Loredana Sabattini, +3905174966217, loredana.sabattini@isnb.it

    Not yet recruiting
  • IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna

    Bologna, BO, 40139

    Kevin Marcaccini, +390514966403, kevin.marcaccini@ausl.bologna.it

    Recruiting

Other trials in Italy

About this study

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

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.

Read the detailed description

Patients with multiple sclerosis (MS) often experience significant gait impairments that impact their autonomy and overall quality of life. One of the primary rehabilitation strategies involves the use of walking braces. While these orthotic devices can support ambulation, their effective integration into daily life typically requires a period of adaptation and specific training. Traditionally, gait training and orthosis prescription occur in clinical settings, which may not fully reflect the real-world challenges that patients encounter. Moreover, current clinical assessments rely primarily on subjective observations and standardized scales, which may lack the sensitivity and objectivity needed to capture the full complexity of gait performance.

virtual reality (VR) offers a promising opportunity to simulate realistic walking environments in a controlled and safe setting, such as an outpatient clinic, potentially enhancing the outcomes of gait rehabilitation. Another promising technology in this domain is the use of wearable inertial sensors, which have been shown to effectively measure gait and postural parameters in people with MS. A further challenge associated with the use of orthotic devices is the physical and psychological stress they may cause, which can lead patients to discontinue their use. To evaluate such discomfort more objectively, recent studies have explored the use of physiological signal analysis and machine learning (ML) algorithms as an alternative or complement to self-reported questionnaires.

The integration of VR with wearable inertial and physiological sensors may allow for a more comprehensive and objective assessment of a patient's adaptation to walking braces. However, no validated system currently exists that combines these technologies for gait assessment and training with passive orthoses in people with MS.

The VIRTUE study aims to address this gap by developing and evaluating a VR-based platform (VIRTUE4MS) that replicates real-life scenarios, such as navigating through a museum, park, or grocery store, and enables standardized gait assessments within immersive environments. The system will employ both inertial and physiological wearable sensors to gather data on gait dynamics and user experience, ultimately supporting clinical decision-making regarding orthotic use. In this study, 12 patients with MS will perform walking and balance tasks over three sessions (T1, T2, T3), both with and without the Exoband brace, in VR and real-world conditions. Ultimately, this study seeks to explore an innovative, technology-supported approach to orthosis assessment and gait training that could complement traditional clinical tools and contribute to more effective, personalized rehabilitation strategies for individuals with MS.

Being tested
VR and walking brace-based gait rehabilitation
Keywords
Multiple sclerosis, Neurorehabilitation, Gait impairments, Virtual Reality, Wearable technology, Sensor-based monitoring, Inertial sensors, Physiological signals, Walking braces, Remote monitoring
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR and walking brace-based gait rehabilitationOther

    The study implements the use of VR and wearable sensors to enhance gait analysis in clinical practice. Participants will take part in two outpatient sessions (T1 and T2) involving the use of VR and wearable sensors, during which they will be asked to complete standardized gait tests and questionnaires. These two sessions will be separated by a one-week home phase (Th), during which participants will wear the walking brace in their daily activities and their gait and physiological data will be recorded by wearable sensors. A final session (T3), conducted without VR, will be scheduled two months later to assess the long-term retention of the intervention effects.

Study groups in NCT07096700
Study groupRoleWhat they receive
VR - Multiple SclerosisOtherTwelve adults with multiple sclerosis who require a walking brace to support ambulation and are compatible with Virtual Reality
Receives: Other: VR and walking brace-based gait rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Score of the standardized tests and gait parameters

    This outcome assesses the adaptation to the walking brace during ambulation. Gait performance across different sessions will be analyzed and compared to observe improvement between T1 and T2. Participant satisfaction with the use of VR will be considered met if individuals can successfully engage with and complete the sessions using the system.

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

Secondary outcomes (13)
  1. NASA-TLX (NASA Task Load Index) questionnaire score

    The NASA-TLX questionnaire score (National Aeronautics and Space Administration Task Load Index) measures physical and mental workload using six items related to mental load, physical activity, speed of performance, performance, effort, and frustration. Each item is accompanied by a 12 cm line scale divided into 20 equal intervals, anchored by binary descriptors (e.g., low/high), delimited by 21 vertical markers, and then converted to a scale from 0 to 100 points. To calculate the score for each scale, the number of lines marked by a participant is counted, 1 is subtracted, and the result is multiplied by 5. Weights from 0-5 will be assigned to the 15 subscale comparisons, which will be multiplied by the corresponding subscale score. The total score (from 0 to 100 points) is estimated by summing the weighted scores and dividing by 15.

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

  2. MSAQ (Motion Sickness Assessment Questionnaire) questionnaire score

    The MSAQ questionnaire assesses motion sickness. It consists of 16 questions divided into four subcategories: Gastrointestinal (G), Central (C), Peripheral (P), and Sopite-related (S). Responses are scored on a scale from 1 to 9 points. Each subcategory is scored individually, contributing to a total score ranging from 11 to 144 points. The overall motion sickness score is calculated as the percentage of total points scored: (sum of all item points / 144) × 100. Subscale scores are calculated similarly as percentages within each factor: (sum of gastrointestinal items / 36) × 100; (sum of central items / 45) × 100; (sum of peripheral items / 27) × 100; (sum of sopite items / 36) × 100.

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

  3. IPQ (iGroupPresence Questionnaire) questionnaire score

    The IPQ questionnaire assesses the sense of presence (SOP - level of immersion in VR) of a VR user. The IPQ consists of 14 items divided into four subcategories: spatial presence, involvement, perceived realism level, and a "sense of being present." All items are rated on a seven-point scale (0-6), with a higher score indicating greater SOP. The total score is obtained by summing the scores of individual items (from 0 to 84 points).

    Measured: T1 (day 2); T2 (day 10)

  4. MusiQoL (Multiple Sclerosis International Quality of Life) questionnaire score

    The MusiQoL questionnaire assesses health-related quality of life specifically in individuals with multiple sclerosis. It consists of 31 items grouped into nine dimensions: daily activities, psychological well-being, symptoms, social relationships, family relationships, relationship with healthcare professionals, emotional well-being, intimate relationships, and leisure activities. Each item is rated on a five-point Likert scale (from 1 = "never" to 5 = "always"). Scores for each dimension are calculated as the mean of the corresponding items, then transformed into a 0-100 scale, with higher scores indicating better quality of life.

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

  5. BBS (Berg Balance Scale) questionnaire score

    The BBS is a clinical assessment tool used to evaluate balance and fall risk in individuals. It consists of 14 functional tasks, each scored on a scale from 0 (unable to perform) to 4 (normal performance), with a maximum total score of 56 points. The items assess the ability to maintain upright standing positions without support (eyes open, closed, feet together, tandem, single-leg stance), perform posture transitions (e.g., sitting to standing, transfers between bed and chair), turn the body, and complete other tasks requiring static and dynamic postural control.

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

  6. EDSS (Expanded Disability Status Scale) questionnaire score

    The EDSS is an ordinal rating scale used to quantify disability in individuals with multiple sclerosis. Scores range from 0 (normal neurological status) to 10 (death due to MS), with 0.5-point increments indicating increasing levels of disability. The scale evaluates several functional systems, including motor, sensory, visual, bowel and bladder functions, and cognitive impairments, providing an overall measure of disability.

    Measured: T0 (day 1)

  7. MFIS (Modified Fatigue Impact Scale) questionnaire score

    The MFIS is a 21-item self-report questionnaire that assesses the perceived impact of fatigue on daily life, covering three domains: physical (0-36), cognitive (0-40), and psychosocial (0-8). Each item is rated from 0 to 4. The total score ranges from 0 to 84, with higher scores indicating greater fatigue impact. Subscale scores provide domain-specific insights, useful for monitoring targeted therapeutic interventions.

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

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

    The MSWS-12 is a self-reported questionnaire designed to measure the impact of MS on walking ability. It consists of 12 items rated on a 5-point scale (1-5), reflecting perceived walking difficulties over the past two weeks. Assessed domains include balance, speed, walking distance, and need for assistance. The total raw score is converted to a 0-100 scale, with higher scores indicating greater walking disability.

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

  9. Timed 25-Foot Walk Test (T25FW) test score

    The T25FW assesses walking speed and is used to evaluate the walking ability of individuals with multiple sclerosis. The test involves the participant walking 25 feet (approximately 7.62 meters) as quickly as possible, performing two separate trials. The time taken to complete each trial is measured in seconds using a stopwatch. The final score is calculated by averaging the two recorded times.

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

  10. 2MWT (2-Minute Walk Test) test score

    The 2MWT is a test used to assess walking ability, in which the subject is asked to walk as fast as possible for 2 minutes on a flat surface. The total distance covered during this time is measured. The test evaluates walking speed, as well as the patient's cardiovascular and muscular endurance.

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

  11. TAM (Technology Acceptance Model) questionnaire score

    The TAM is a tool used to measure users' acceptance of technology, based on two key components: perceived usefulness (how much the user believes the technology improves their performance) and perceived ease of use (how easy the user finds the technology to use). The test includes 12 items scored from 1 to 4, with a total score of 48. Higher scores indicate lower acceptance of the technology.

    Measured: T0 (day 1); T2 (day 10)

  12. TLSQ-WT (Tele-healthcare Satisfaction Questionnaire - Wearable Technology) questionnaire score

    The TLSQ-WT is an assessment tool designed to measure patients' satisfaction with telemedicine services. It evaluates six dimensions of the user experience with the wearable component of a system: Benefits, Usability, Self-perception, Privacy and Loss of Control, Quality of Life, and Comfort of Use.

    Each area includes five statements rated by the user on a 5-point Likert scale from 0 (strongly disagree) to 4 (strongly agree), for a total of 30 items. The final score ranges from 0 to 120.

    Measured: T2 (day 10)

  13. Timed Up and Go (TUG) test score

    The TUG (Podsiadlo \& Richardson, 1991) is a functional test commonly used to assess mobility and fall risk in patients with neurological conditions, including multiple sclerosis. The test involves asking the patient to stand up from a chair, walk 3 meters, turn around, walk back, and sit down again. The time required to complete the task is recorded in seconds using a stopwatch.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2025
  2. Study start2 Mar 2026
  3. Primary completionJun 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07096700
Sponsor's protocol ID
VIRTUE
Acronym
VIRTUE
Status last verified
Mar 2026
First submitted
24 Jul 2025
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tsai MF, Bandini A, Wang RH, Zariffa J. Capturing Representative Hand Use at Home Using Egocentric Video in Individuals with Upper Limb Impairment. J Vis Exp. 2020 Dec 23;(166). doi: 10.3791/61898.

    PubMed 33427235
  • Casuso-Holgado MJ, Martin-Valero R, Carazo AF, Medrano-Sanchez EM, Cortes-Vega MD, Montero-Bancalero FJ. Effectiveness of virtual reality training for balance and gait rehabilitation in people with multiple sclerosis: a systematic review and meta-analysis. Clin Rehabil. 2018 Sep;32(9):1220-1234. doi: 10.1177/0269215518768084. Epub 2018 Apr 13.

    PubMed 29651873
  • Peruzzi A, Cereatti A, Della Croce U, Mirelman A. Effects of a virtual reality and treadmill training on gait of subjects with multiple sclerosis: a pilot study. Mult Scler Relat Disord. 2016 Jan;5:91-6. doi: 10.1016/j.msard.2015.11.002. Epub 2015 Nov 6.

    PubMed 26856951
  • Bettoni E, Ferriero G, Bakhsh H, Bravini E, Massazza G, Franchignoni F. A systematic review of questionnaires to assess patient satisfaction with limb orthoses. Prosthet Orthot Int. 2016 Apr;40(2):158-69. doi: 10.1177/0309364614556836. Epub 2014 Nov 26.

    PubMed 25428901
  • Marimon X, Mengual I, Lopez-de-Celis C, Portela A, Rodriguez-Sanz J, Herraez IA, Perez-Bellmunt A. Kinematic Analysis of Human Gait in Healthy Young Adults Using IMU Sensors: Exploring Relevant Machine Learning Features for Clinical Applications. Bioengineering (Basel). 2024 Jan 23;11(2):105. doi: 10.3390/bioengineering11020105.

    PubMed 38391591
  • Panizzolo FA, Cimino S, Pettenello E, Belfiore A, Petrone N, Marcolin G. Effect of a passive hip exoskeleton on walking distance in neurological patients. Assist Technol. 2022 Sep 3;34(5):527-532. doi: 10.1080/10400435.2021.1880494. Epub 2021 Mar 5.

    PubMed 33481693
  • Karunakaran KK, Pamula SD, Bach CP, Legelen E, Saleh S, Nolan KJ. Lower extremity robotic exoskeleton devices for overground ambulation recovery in acquired brain injury-A review. Front Neurorobot. 2023 May 25;17:1014616. doi: 10.3389/fnbot.2023.1014616. eCollection 2023.

    PubMed 37304666
  • Homayuni A, Abedini S, Hosseini Z, Etemadifar M, Ghanbarnejad A. Explaining the facilitators of quality of life in patients with multiple sclerosis: a qualitative study. BMC Neurol. 2021 May 11;21(1):193. doi: 10.1186/s12883-021-02213-9.

    PubMed 33975555
  • Gil-Gonzalez I, Martin-Rodriguez A, Conrad R, Perez-San-Gregorio MA. Quality of life in adults with multiple sclerosis: a systematic review. BMJ Open. 2020 Nov 30;10(11):e041249. doi: 10.1136/bmjopen-2020-041249.

    PubMed 33257490
  • Marcaccini K, Aleo A, Pozzi S, Sgambato G, Chiari L, Verrengia MG, Milano DC, Moscato S, Mellone S, Arcobelli VA, Sabattini L, Orlandi S. Interventional Feasibility Study Investigating Virtual Reality-Based Gait Assessment With Orthoses in People With Multiple Sclerosis: A Study Protocol. Clin Transl Sci. 2026 Sep;19(9):e70728. doi: 10.1111/cts.70728.

    PubMed 42717397

Questions about this trial

What is this clinical trial studying?

A study testing VR and walking brace-based gait rehabilitation in people with Multiple Sclerosis, run by Azienda Usl di Bologna at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kevin Marcaccini (+390514966403, kevin.marcaccini@ausl.bologna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score of the standardized tests and gait parameters (time frame: From T1 (day 2) to T2 (day 9)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07096700, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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