Neurophysiological and Clinical Effects of Upper Limb Robot-Assisted Rehabilitation on Motor Recovery in Patients with Subacute Stroke: A Multicenter Randomized Controlled Trial Study Protocol

Sanaz Pournajaf; Giovanni Morone; Sofia Straudi; Michela Goffredo; Maria Rosaria Leo; Rocco Salvatore Calabrò; Giorgio Felzani; Stefano Paolucci; Serena Filoni; Andrea Santamato; Marco Franceschini; The Italian PowerUPS-Rehab Study Group

doi:10.3390/brainsci13040700

Neurophysiological and Clinical Effects of Upper Limb Robot-Assisted Rehabilitation on Motor Recovery in Patients with Subacute Stroke: A Multicenter Randomized Controlled Trial Study Protocol

Brain Sci. 2023 Apr 21;13(4):700. doi: 10.3390/brainsci13040700.

Authors

Affiliations

¹ IRCSS San Raffaele Roma, 000163 Rome, Italy.
² Department of Life, Health and Environmental Sciences, University of L'Aquila, 67100 L'Aquila, Italy.
³ San Raffaele Istitute of Sulmona, 67039 Sulmona, Italy.
⁴ Department of Neuroscience and Rehabilitation, University of Ferrara, 44121 Ferrara, Italy.
⁵ Department of Neuroscience and Rehabilitation, Ferrara University Hospital, 44121 Ferrara, Italy.
⁶ Villa Bellombra Hospital, 40132 Bologna, Italy.
⁷ IRCCS Centro Neurolesi Bonino-Pulejo, 98124 Messina, Italy.
⁸ IRCCS Fondazione Santa Lucia, 00124 Rome, Italy.
⁹ Fondazione Centri di Riabilitazione Padre Pio Onlus, San Giovani Rotondo, 71013 Foggia, Italy.
¹⁰ Physical Medicine and Rehabilitative Unit-Riuniti Hospital, University of Foggia, 71100 Foggia, Italy.
¹¹ Department of Human Sciences and Promotion of the Quality of Life, San Raffaele University, 00166 Rome, Italy.

Abstract

Background: The efficacy of upper limb (UL) robot-assisted therapy (RAT) on functional improvement after stroke remains unclear. However, recently published randomized controlled trials have supported its potential benefits in enhancing the activities of daily living, arm and hand function, and muscle strength. Task-specific and high-intensity exercises are key points in facilitating motor re-learning in neurorehabilitation since RAT can provide an assisted-as-needed approach. This study aims to investigate the clinical effects of an exoskeleton robotic system for UL rehabilitation compared with conventional therapy (CT) in people with subacute stroke. As a secondary aim, we seek to identify patients' characteristics, which can predict better recovery after UL-RAT and detects whether it could elicit greater brain stimulation.

Methods: A total of 84 subacute stroke patients will be recruited from 7 Italian rehabilitation centers over 3 years. The patients will be randomly allocated to either CT (control group, CG) or CT plus UL-RT through an Armeo^®Power (Hocoma AG, CH, Volketswil, Switzerland) exoskeleton (experimental group, EG). A sample stratification based on distance since onset, DSO (DSO ≤ 30; DSO > 30), and Fugl-Meyer Assessment (FM)-UL (FM-UL ≤ 22; 22 < FM-UL ≤ 44) will be considered for the randomization. The outcomes will be recorded at baseline (T0), after 25 + 3 sessions of intervention (T1), and at 6 months post-stroke (T2). The motor functioning assessed by the FM-UL (0-66) will be considered the primary outcome. The clinical assessments will be set based on the International Classification of Function, Disability and Health (ICF). A patient satisfaction questionnaire will be evaluated in the EG at T1. A subgroup of patients will be evaluated at T0 and T1 via electroencephalography. Their brain electrical activity will be recorded during rest conditions with their eyes closed and open (5 min each).

Conclusion: The results of this trial will provide an in-depth understanding of the efficacy of early UL-RAT through a whole arm exoskeleton and how it may relate to the neural plasticity process. The trial was registered at ClinicalTrial.gov with the registration identifier NCT04697368.

Keywords: EEG; neuroplasticity; rehabilitation; robot-assisted therapy; stroke; upper limb functions.

Associated data

ClinicalTrials.gov/NCT04697368

Grants and funding

For Sanaz Pournajaf, Rocco Salvatore Calabrò, Stefano Paolucci, Michela Goffredo, and Marco Franceschini, the research activity was partially funded by the Italian Ministry of Health (Ricerca Corrente). The funders played no role in the design, operation, or reporting of this study. The authors report no involvement of the sponsor in the research that could have influenced the outcome of this work.