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Randomized Controlled Trial
. 2025 Oct;46(10):5221-5233.
doi: 10.1007/s10072-025-08367-5. Epub 2025 Jul 18.

An early feasibility study for neurological devices: The ARCTRAN study

Francesco Bove #  1   2 , Giulia Di Lazzaro #  1   2 , Martina Petracca #  1   2 , Maria Rita Lo Monaco  3   4 , Diego Ricciardi  5 , Francesca Di Caro  5 , Serena Fragapane  2 , Silvia Giovannini  4   5 , Chiara Iacovelli  6 , Letizia Castelli  2 , Assunta Bianco  1 , Irene Scala  1 , Aldobrando Broccolini  1   2 , Pietro Caliandro  1   2 , Domenica Le Pera  7 , Carmen Furno  8 , Giovanni Arcuri  8 , Guerino Massimo Oscar Fares  9 , Federico Spandonaro  10   11 , Barbara Polistena  10   11 , Paolo Calabresi #  12   13 , Anna Rita Bentivoglio #  1   2
Affiliations
Randomized Controlled Trial

An early feasibility study for neurological devices: The ARCTRAN study

Francesco Bove et al. Neurol Sci. 2025 Oct.

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.

Keywords: Early feasibility study; Multiple sclerosis; Parkinson’s disease; Stroke; Telerehabilitation.

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Conflict of interest statement

Declarations. Competing Interests: Authors declare no competing interests. Conflict of interest: The authors have no relevant financial or non-financial interests to disclose. Ethical approval: This study was approved by the local Ethics Committee. Informed consent: Informed consent was obtained from all individual participants included in the study.

Figures

Fig. 1
Fig. 1
ARCTRAN study timeline
Fig. 2
Fig. 2
Tinetti gait score changes between T0 and T2 in the three groups
Fig. 3
Fig. 3
Patient-reported adherence to treatment in the three groups of patients
See this image and copyright information in PMC

References

    1. (2013) US Food and Drug Administration, Center for Biologics Evaluation and Research. Investigational device exemptions (IDEs) for early feasibility medical device clinical studies, including certain first in human (FIH) studies: guidance for industry and food and drug administration staff. Available from: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/...
    1. (2017) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
    1. (2021) Italian Ministry of Health, Directorate General for Medical Devices. Notifica di indagini cliniche svolte con dispositivi medici non recanti la marcatura CE (pre market). Available from: http://www.salute.gov.it/portale/ministro/p4_8_0.jsp?lingua=italiano26la...
    1. O’Malley N, Clifford AM, Conneely M, Casey B, Coote S (2021) Effectiveness of interventions to prevent falls for people with multiple sclerosis, parkinson’s disease and stroke: an umbrella review. BMC Neurol 21:378. 10.1186/s12883-021-02402-6 - PMC - PubMed
    1. Farag I, Sherrington C, Hayes A, Canning CG, Lord SR, Close JC, Fung VS, Howard K (2016) Economic evaluation of a falls prevention exercise program among people with parkinson’s disease. Mov Disord 31:53–61. 10.1002/mds.26420 - PubMed

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