Evidence map›Paper›PMID 41877259›Full record

Trial reportTrials2026

Investigating the role of therapist-patient interaction during robot-assisted gait training after incomplete spinal cord injury: the INTER-RO-GAIT randomized controlled trial.

Jlenia Toppi, Floriana Pichiorri, Angela Ciaramidaro, Shiva Mohebban, Francesca Patarini, Nevio Luigi Tagliamonte, Francesco Di Tommaso, Marica Ferrara, Maristella Scorza, Alessandra Bigioni and 5 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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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

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

15 authors.

Jlenia ToppiDepartment of Computer, Control and Management Engineering, Sapienza University of Rome, Rome, Italy.
Floriana PichiorriNeuroelectrical Imaging and Brain Computer Interface Lab, IRCCS Fondazione Santa Lucia, Rome, Italy. f.pichiorri@hsantalucia.it.
Angela CiaramidaroDepartment of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Reggio Emilia, Italy.
Shiva MohebbanDepartment of Computer, Control and Management Engineering, Sapienza University of Rome, Rome, Italy.
Francesca PatariniDepartment of Computer, Control and Management Engineering, Sapienza University of Rome, Rome, Italy.
Nevio Luigi TagliamonteResearch Unit of Advanced Robotics and Human-Centred Technologies, Università Campus Bio-Medico Di Roma, Rome, Italy.
Francesco Di TommasoResearch Unit of Advanced Robotics and Human-Centred Technologies, Università Campus Bio-Medico Di Roma, Rome, Italy.
Marica FerraraResearch Unit of Advanced Robotics and Human-Centred Technologies, Università Campus Bio-Medico Di Roma, Rome, Italy.
Maristella ScorzaDepartment of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Reggio Emilia, Italy.
Alessandra BigioniLaboratory of Robotic Neurorehabilitation, Neurorehabilitation 1 Department, Fondazione Santa Lucia, Rome, Italy.
Giada SerratoreLaboratory of Robotic Neurorehabilitation, Neurorehabilitation 1 Department, Fondazione Santa Lucia, Rome, Italy.
Giordano GureddaLaboratory of Robotic Neurorehabilitation, Neurorehabilitation 1 Department, Fondazione Santa Lucia, Rome, Italy.
Giorgio ScivolettoSpinal Unit, CTO Andrea Alesini Hospital, Rome, Italy.
Donatella MattiaNeuroelectrical Imaging and Brain Computer Interface Lab, IRCCS Fondazione Santa Lucia, Rome, Italy.
Federica TamburellaLaboratory of Robotic Neurorehabilitation, Neurorehabilitation 1 Department, Fondazione Santa Lucia, Rome, Italy.

Funding

Ministero della Salute GR-2019-12369207
6 · The paper itself

Abstract

backgroundIn the neurorehabilitation framework of treadmill-based robot-assisted gait training (t-RAGT), a threefold relationship among physiotherapist (Pht), patient (Pt), and the selected robotic device should be considered. Furthermore, the type of visual FeedBack (FB) selected for the training and how the Pht guides and supports the Pt have an important impact on Pt's engagement. Pht-Pt interaction is mostly effective when FB with high technical content is employed, and it affects Pt's visual attention and emotional experience during training. The INTER-RO-GAIT project proposes an experimental modulation of Pht-Pt interaction during the training with the Lokomat device, to primarily investigate its role in the effectiveness of t-RAGT for individuals with subacute and chronic incomplete spinal cord injury (i-SCI) through a longitudinal randomized controlled trial (RCT), by means of clinical scales and biomechanical data. Timed walking tests for gait speed evaluation (10-Meter Walking Test and 6-Minute Walking Test) are considered as primary outcome measures, while clinical scales for the assessment of lower limbs' force, spasticity, pain, clonus, spasms, and independence in activities of daily living are selected as secondary outcome measures. The biomechanical assessment includes overground gait analysis to assess recovery of motor functions, and human-Lokomat interaction analysis to measure the active Pt participation in the exercise and evaluate its evolution along training. Secondary aims are as follows: (i) to identify neurophysiological indices derived from electroencephalography (EEG) hyperscanning data monitoring the Pht-Pt relationship along t-RAGT; (ii) to evaluate the Pt's engagement in terms of Visual Attention during the RAGT; (iii) to investigate the correlation between the rehabilitation outcome and the neurophysiological indices or the psychological metrics referring to Pht-Pt relationship.

methodsFifty participants from I.R.C.C.S. Fondazione Santa Lucia (Rome, Italy) will be enrolled and randomized into a single-blind RCT to investigate the effects of 12 Lokomat t-RAGT sessions administered with two different levels of Pht-Pt interaction (high level of interaction for the experimental (EXP) group and low level of interaction for the control (CTRL) group), as an add-on training to conventional rehabilitation. Before and after the whole t-RAGT, as well as at the first, the mid, and the last training session, a battery of clinical, biomechanical, psychological, and neurophysiological assessments will be conducted. DISCUSSION: Given that incomplete subacute or chronic SCI may lead to long-term disability for which cost-effective rehabilitation options are critically needed, INTER-RO-GAIT aims at providing evidence for an optimal Pht-Pt interaction to potentially boost the t-RAGT effects on Pts' performance, improving robotic rehabilitation protocols and devices development even beyond the specific gait application.

trial registrationPatient-therapist INTERaction During RObotic GAIT Rehabilitation After Spinal Cord Injury (INTER-RO-GAIT); ClinicalTrial.gov platform registration number: GR-2019-12369207 on 31st July 2024.

Indexed as

Exercise TherapyGaitPhysical TherapistsProfessional-Patient RelationsRoboticsSpinal Cord InjuriesAdultBiomechanical PhenomenaFeedback, SensoryFemaleHumansMaleRecovery of FunctionTime FactorsTreatment OutcomeBody weight supportEEG hyperscanningIncomplete SCILokomatPhysiotherapist–patient interactionT-RAGTTreadmill

Identifiers

PMID41877259
PMCPMC13134159

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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.