Evidence map›Paper›PMID 40679690›Full record

Trial reportNeurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology2025

An early feasibility study for neurological devices: The ARCTRAN study.

Francesco Bove, Giulia Di Lazzaro, Martina Petracca, Maria Rita Lo Monaco, Diego Ricciardi, Francesca Di Caro, Serena Fragapane, Silvia Giovannini, Chiara Iacovelli, Letizia Castelli and 12 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

22 authors.

Francesco Bove *Neurology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Giulia Di Lazzaro *Neurology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Martina Petracca *Neurology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Maria Rita Lo MonacoGeriatrics Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Diego RicciardiUOS Riabilitazione Post-Acuzie, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Francesca Di CaroUOS Riabilitazione Post-Acuzie, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Serena FragapaneDepartment of Neuroscience, Università Cattolica del Sacro Cuore, Largo Francesco Vito 1, Roma, 00168, Italia.
Silvia GiovanniniDepartment of Geriatrics and Orthopaedics, Università Cattolica del Sacro Cuore, Rome, Italy.
Chiara IacovelliDepartment of Emergency, Anaesthesiology and Intensive Care Medicine, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Letizia CastelliDepartment of Neuroscience, Università Cattolica del Sacro Cuore, Largo Francesco Vito 1, Roma, 00168, Italia.
Assunta BiancoNeurology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Irene ScalaNeurology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Aldobrando BroccoliniNeurology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Pietro CaliandroNeurology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Domenica Le PeraIRCCS San Raffaele Roma-Pisana, Rome, Italy.
Carmen FurnoHealth Technologies Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.
Giovanni ArcuriHealth Technologies Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.
Guerino Massimo Oscar FaresUniversità Roma Tre - Dipartimento di Scienze della formazione - Centro di ricerca Innovazione & Salute, Rome, Italy.
Federico SpandonaroUniversità degli Studi di Roma Tor Vergata, Rome, Italy.
Barbara PolistenaUniversità degli Studi di Roma Tor Vergata, Rome, Italy.
Paolo Calabresi *Neurology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. paolo.calabresi@policlinicogemelli.it.
Anna Rita Bentivoglio *Neurology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAn Early Feasibility Study (EFS) is an exploratory clinical investigation of a device to optimize its design through iterative feedback loops during early clinical experience. The ARCTRAN study is an EFS aimed at analyzing efficacy, safety and adherence to the home-rehabilitation device-based (ARC Intellicare) program compared to a paper-based exercise protocol in patients with Parkinson's disease (PD), Multiple Sclerosis (MS) and stroke. MATERIALS AND

methodsAt baseline (T0), patients of each group were randomly divided into two arms, with a 1:1 ratio: an 'interventional' group received ARC Intellicare and a 'control' group received a paper-based rehabilitation protocol, both consisting of three 60-minute sessions/week for 8 weeks. Each patient was evaluated by means of clinical scales, gait analysis and stabilometry at baseline (T0) and after the rehabilitation (T2).

resultsAll patients (n = 90, 30 per group) showed a significant improvement in clinical scales between T0 and T2. Stroke patients showed a bigger gait improvement in the ARC Intellicare arm, measured both by clinical scales (Tinetti gait p = 0.01) and gait analysis parameters. In PD group, only gait analysis parameters recorded a significant improvement in the active arm. DISCUSSION: We demonstrate the safety of ARC Intellicare for home-based rehabilitation in patients with chronic neurological conditions, with high adherence levels. Moreover, in stroke group, it produced more significant improvements of gait compared to paper-based protocol. In the global scenario of the EFS projects promoted by the Italian Ministry of Health, this study is a starting point to conduct this type of studies in Italy.

Indexed as

Exercise TherapyMultiple SclerosisNeurological RehabilitationParkinson DiseaseStroke RehabilitationAdultAgedFeasibility StudiesFemaleHumansMaleMiddle AgedStrokeEarly feasibility studyMultiple sclerosisParkinson’s diseaseStrokeTelerehabilitation

Identifiers

PMID40679690
PMCPMC12488755

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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 Socratic graph.