View in EDS HTML Full Text PDF Full Text

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

Saved in:
Bibliographic Details
Title: An early feasibility study for neurological devices: The ARCTRAN study.
Authors: Bove, Francesco (AUTHOR), Di Lazzaro, Giulia (AUTHOR), Petracca, Martina (AUTHOR), Lo Monaco, Maria Rita (AUTHOR), Ricciardi, Diego (AUTHOR), Di Caro, Francesca (AUTHOR), Fragapane, Serena (AUTHOR), Giovannini, Silvia (AUTHOR), Iacovelli, Chiara (AUTHOR), Castelli, Letizia (AUTHOR), Bianco, Assunta (AUTHOR), Scala, Irene (AUTHOR), Broccolini, Aldobrando (AUTHOR), Caliandro, Pietro (AUTHOR), Le Pera, Domenica (AUTHOR), Furno, Carmen (AUTHOR), Arcuri, Giovanni (AUTHOR), Fares, Guerino Massimo Oscar (AUTHOR), Spandonaro, Federico (AUTHOR), Polistena, Barbara (AUTHOR)
Source: Neurological Sciences. Oct2025, Vol. 46 Issue 10, p5221-5233. 13p.
Subjects: Home rehabilitation, Parkinson's disease, Medical sciences, Neurological disorders, Stroke
Abstract: Introduction: An 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 Methods: At 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). Results: All 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. [ABSTRACT FROM AUTHOR]
Copyright of Neurological Sciences is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
Full text is not displayed to guests.
FullText Links:
  – Type: pdflink
Text:
  Availability: 1
Header DbId: pbh
DbLabel: Psychology and Behavioral Sciences Collection
An: 188452380
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: An early feasibility study for neurological devices: The ARCTRAN study.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AR" term="%22Bove%2C+Francesco%22">Bove, Francesco</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Di+Lazzaro%2C+Giulia%22">Di Lazzaro, Giulia</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Petracca%2C+Martina%22">Petracca, Martina</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lo+Monaco%2C+Maria+Rita%22">Lo Monaco, Maria Rita</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ricciardi%2C+Diego%22">Ricciardi, Diego</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Di+Caro%2C+Francesca%22">Di Caro, Francesca</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Fragapane%2C+Serena%22">Fragapane, Serena</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Giovannini%2C+Silvia%22">Giovannini, Silvia</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Iacovelli%2C+Chiara%22">Iacovelli, Chiara</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Castelli%2C+Letizia%22">Castelli, Letizia</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Bianco%2C+Assunta%22">Bianco, Assunta</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Scala%2C+Irene%22">Scala, Irene</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Broccolini%2C+Aldobrando%22">Broccolini, Aldobrando</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Caliandro%2C+Pietro%22">Caliandro, Pietro</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Le+Pera%2C+Domenica%22">Le Pera, Domenica</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Furno%2C+Carmen%22">Furno, Carmen</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Arcuri%2C+Giovanni%22">Arcuri, Giovanni</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Fares%2C+Guerino+Massimo+Oscar%22">Fares, Guerino Massimo Oscar</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Spandonaro%2C+Federico%22">Spandonaro, Federico</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Polistena%2C+Barbara%22">Polistena, Barbara</searchLink> (AUTHOR)
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22Neurological+Sciences%22">Neurological Sciences</searchLink>. Oct2025, Vol. 46 Issue 10, p5221-5233. 13p.
– Name: Subject
  Label: Subjects
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22Home+rehabilitation%22">Home rehabilitation</searchLink><br /><searchLink fieldCode="DE" term="%22Parkinson's+disease%22">Parkinson's disease</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+sciences%22">Medical sciences</searchLink><br /><searchLink fieldCode="DE" term="%22Neurological+disorders%22">Neurological disorders</searchLink><br /><searchLink fieldCode="DE" term="%22Stroke%22">Stroke</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Introduction: An 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 Methods: At 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). Results: All 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. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of Neurological Sciences is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=pbh&AN=188452380
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1007/s10072-025-08367-5
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 13
        StartPage: 5221
    Subjects:
      – SubjectFull: Home rehabilitation
        Type: general
      – SubjectFull: Parkinson's disease
        Type: general
      – SubjectFull: Medical sciences
        Type: general
      – SubjectFull: Neurological disorders
        Type: general
      – SubjectFull: Stroke
        Type: general
    Titles:
      – TitleFull: An early feasibility study for neurological devices: The ARCTRAN study.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Bove, Francesco
      – PersonEntity:
          Name:
            NameFull: Di Lazzaro, Giulia
      – PersonEntity:
          Name:
            NameFull: Petracca, Martina
      – PersonEntity:
          Name:
            NameFull: Lo Monaco, Maria Rita
      – PersonEntity:
          Name:
            NameFull: Ricciardi, Diego
      – PersonEntity:
          Name:
            NameFull: Di Caro, Francesca
      – PersonEntity:
          Name:
            NameFull: Fragapane, Serena
      – PersonEntity:
          Name:
            NameFull: Giovannini, Silvia
      – PersonEntity:
          Name:
            NameFull: Iacovelli, Chiara
      – PersonEntity:
          Name:
            NameFull: Castelli, Letizia
      – PersonEntity:
          Name:
            NameFull: Bianco, Assunta
      – PersonEntity:
          Name:
            NameFull: Scala, Irene
      – PersonEntity:
          Name:
            NameFull: Broccolini, Aldobrando
      – PersonEntity:
          Name:
            NameFull: Caliandro, Pietro
      – PersonEntity:
          Name:
            NameFull: Le Pera, Domenica
      – PersonEntity:
          Name:
            NameFull: Furno, Carmen
      – PersonEntity:
          Name:
            NameFull: Arcuri, Giovanni
      – PersonEntity:
          Name:
            NameFull: Fares, Guerino Massimo Oscar
      – PersonEntity:
          Name:
            NameFull: Spandonaro, Federico
      – PersonEntity:
          Name:
            NameFull: Polistena, Barbara
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 10
              Text: Oct2025
              Type: published
              Y: 2025
          Identifiers:
            – Type: issn-print
              Value: 15901874
          Numbering:
            – Type: volume
              Value: 46
            – Type: issue
              Value: 10
          Titles:
            – TitleFull: Neurological Sciences
              Type: main
ResultId 1