Evidence map›Paper›PMID 42717397›Full record

ArticleClinical and translational science2026

Interventional Feasibility Study Investigating Virtual Reality-Based Gait Assessment With Orthoses in People With Multiple Sclerosis: A Study Protocol.

Kevin Marcaccini, Alessandro Aleo, Stefania Pozzi, Giorgia Sgambato, Lorenzo Chiari, Maria Giovanna Verrengia, Domenica Chiara Milano, Serena Moscato, Sabato Mellone, Valerio Antonio Arcobelli and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07096700 (Virtual Reality for Gait Training in Multiple Sclerosis), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07096700 narecruitingnot on this map

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

TypeinterventionalSponsorAzienda Usl di BolognaRan2026 to 2026Enrolled12ConditionsMultiple SclerosisArmsVR and walking brace-based gait rehabilitation
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Kevin MarcacciniDepartment of Electrical, Electronic, and Information Engineering "Guglielmo Marconi" (DEI), University of Bologna, Bologna, Italy.ORCID https://orcid.org/0009-0000-6096-5267
Alessandro AleoIRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.ORCID https://orcid.org/0009-0004-6778-4310
Stefania PozziUO DATER Riabilitazione Ospedaliera, Azienda USL Bologna, Bologna, Italy.ORCID https://orcid.org/0000-0002-7451-6566
Giorgia SgambatoIRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.ORCID https://orcid.org/0009-0008-4441-0964
Lorenzo ChiariDepartment of Electrical, Electronic, and Information Engineering "Guglielmo Marconi" (DEI), University of Bologna, Bologna, Italy.ORCID https://orcid.org/0000-0002-2318-4370
Maria Giovanna VerrengiaRehabilitation Bioengineering Lab, IRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.ORCID https://orcid.org/0009-0004-3432-2734
Domenica Chiara MilanoIRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.ORCID https://orcid.org/0009-0000-2546-6411
Serena MoscatoDepartment of Electrical, Electronic, and Information Engineering "Guglielmo Marconi" (DEI), University of Bologna, Bologna, Italy.ORCID https://orcid.org/0000-0002-0538-650X
Sabato MelloneDepartment of Electrical, Electronic, and Information Engineering "Guglielmo Marconi" (DEI), University of Bologna, Bologna, Italy.ORCID https://orcid.org/0000-0001-7688-0188
Valerio Antonio ArcobelliDepartment of Electrical, Electronic, and Information Engineering "Guglielmo Marconi" (DEI), University of Bologna, Bologna, Italy.ORCID https://orcid.org/0000-0002-1262-9899
Loredana SabattiniIRCCS Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy.ORCID https://orcid.org/0000-0002-6196-6672
Silvia OrlandiDepartment of Electrical, Electronic, and Information Engineering "Guglielmo Marconi" (DEI), University of Bologna, Bologna, Italy.ORCID https://orcid.org/0000-0001-9201-9398

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Multiple sclerosis (MS) often leads to significant impairments in gait and mobility. Although walking braces are commonly prescribed, their real-world effectiveness is limited by insufficient adaptation. Traditional clinical assessments rely on subjective scales and may not fully reflect daily-life challenges. Immersive virtual reality (VR) and wearable sensors offer promising solutions for ecological monitoring, but their combined use remains unvalidated for orthotic support in MS. This interventional study examines the feasibility of a novel, VR-based framework designed to support gait assessment with a passive walking brace. Twelve participants with MS will undergo a protocol combining four ambulatory sessions and a week-long home-monitoring phase. Standardized gait tests will be performed with and without the brace across both simulated scenarios and real-world conditions. Multimodal data collected via inertial and physiological wearable sensors will characterize spatiotemporal gait parameters, balance, posture, and physiological responses, alongside standardized clinical scales and subjective questionnaires. Overall feasibility will be evaluated directly through user usability and acceptability, recruitment and retention rates, safety, protocol adherence, and data completeness. Given that this pilot study is not powered to assess clinical efficacy, statistical analysis will focus strictly on descriptive and exploratory comparisons across conditions and sessions. This translational framework aims to establish robust feasibility metrics to support the design of future, larger-scale controlled trials. Ultimately, these preliminary observations will inform more ecologically valid, personalized rehabilitation strategies to improve the integration of assistive technologies into patients' daily lives. Trial Registration: ClinicalTrials.gov, NCT07096700. Registered July 24, 2025.

Indexed as

Gait AnalysisMultiple SclerosisOrthotic DevicesVirtual RealityAdultBracesFeasibility StudiesFemaleGaitHumansMaleMiddle AgedPilot ProjectsWalkingWearable Electronic Devicesgait impairmentsinertial sensorsmultiple sclerosisneurorehabilitationphysiological signalssensor‐based monitoringvirtual realitywalking braceswearable sensor

Identifiers

PMID42717397
PMCPMC13558658

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.