Efficacy of a Rehabilitation Treatment Using Action Observation Therapy Enhanced by Muscle Synergy-Derived Electrical Stimulation (OTHELLO) in Post-Stroke Patients: A RCT Study Protocol

Background: Action Observation Therapy (AOT) and Neuromuscular Electrical Stimulation (NMES) are widely adopted techniques for upper-limb rehabilitation in post-stroke patients. Although AOT and NMES are individually effective, studies investigating a potential synergistic effect on enhancing rehabi...

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Main Authors: Monia Cabinio, Tiziana Lencioni, Arturo Nuara, Federica Rossetto, Valeria Blasi, Gaia Bailo, Rebecca Cardini, Rita Bertoni, Alessandro Viganò, Mariangela Bianco, Angela Comanducci, Pietro Avanzini, Maurizio Ferrarin, Luca Fornia, Francesca Baglio
Format: Article
Language:English
Published: SAGE Publishing 2025-03-01
Series:Journal of Central Nervous System Disease
Online Access:https://doi.org/10.1177/11795735251331511
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author Monia Cabinio
Tiziana Lencioni
Arturo Nuara
Federica Rossetto
Valeria Blasi
Gaia Bailo
Rebecca Cardini
Rita Bertoni
Alessandro Viganò
Mariangela Bianco
Angela Comanducci
Pietro Avanzini
Maurizio Ferrarin
Luca Fornia
Francesca Baglio
author_facet Monia Cabinio
Tiziana Lencioni
Arturo Nuara
Federica Rossetto
Valeria Blasi
Gaia Bailo
Rebecca Cardini
Rita Bertoni
Alessandro Viganò
Mariangela Bianco
Angela Comanducci
Pietro Avanzini
Maurizio Ferrarin
Luca Fornia
Francesca Baglio
author_sort Monia Cabinio
collection DOAJ
description Background: Action Observation Therapy (AOT) and Neuromuscular Electrical Stimulation (NMES) are widely adopted techniques for upper-limb rehabilitation in post-stroke patients. Although AOT and NMES are individually effective, studies investigating a potential synergistic effect on enhancing rehabilitative outcomes are lacking. Objectives: This study aims at comparing the effect of AOT and NMES applied together (AOT-NMES) on muscle synergies with respect to either AOT alone or a Motor Neutral Observation treatment alone (MNO, involving neither AOT nor NMES) on motor function recovery of upper limb. Design: Randomized Controlled Trial (RCT) with n = 60 post-stroke patients with resulting upper limb disability, randomly allocated (1:1:1 ratio) in three interventional arms: AOT-NMES (n = 20), AOT (n = 20) and MNO (n = 20). Methods and Analyses: All rehabilitation treatments will consist of n°15 60 min-long rehabilitative sessions. Primary outcome measure will be upper limb motor function, assessed using the Fugl-Meyer Assessment scale for upper limb (FM-UL), collected at the baseline (T0), post-intervention (T1) and at follow-up (T2, 6-months after T1). Other outcome measures will be collected through a multidimensional evaluation including assessing stroke-associated quality of life, neurophysiological data, biomechanical and MRI measures. The innovative protocol will also be evaluated for usability and safety. Discussion: We expect to determine the efficacy, usability and safety of the AOT-NMES rehabilitation approach for the recovery of upper limb motor function in post-stroke patients. The obtained results will also help reveal the neural underpinnings of motor recovery, as assessed by neurophysiological data, biomechanical and MRI measures.
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spelling doaj-art-3c6f9bca20f44240ad1fdfcafbdf62502025-08-20T02:15:28ZengSAGE PublishingJournal of Central Nervous System Disease1179-57352025-03-011710.1177/11795735251331511Efficacy of a Rehabilitation Treatment Using Action Observation Therapy Enhanced by Muscle Synergy-Derived Electrical Stimulation (OTHELLO) in Post-Stroke Patients: A RCT Study ProtocolMonia CabinioTiziana LencioniArturo NuaraFederica RossettoValeria BlasiGaia BailoRebecca CardiniRita BertoniAlessandro ViganòMariangela BiancoAngela ComanducciPietro AvanziniMaurizio FerrarinLuca ForniaFrancesca BaglioBackground: Action Observation Therapy (AOT) and Neuromuscular Electrical Stimulation (NMES) are widely adopted techniques for upper-limb rehabilitation in post-stroke patients. Although AOT and NMES are individually effective, studies investigating a potential synergistic effect on enhancing rehabilitative outcomes are lacking. Objectives: This study aims at comparing the effect of AOT and NMES applied together (AOT-NMES) on muscle synergies with respect to either AOT alone or a Motor Neutral Observation treatment alone (MNO, involving neither AOT nor NMES) on motor function recovery of upper limb. Design: Randomized Controlled Trial (RCT) with n = 60 post-stroke patients with resulting upper limb disability, randomly allocated (1:1:1 ratio) in three interventional arms: AOT-NMES (n = 20), AOT (n = 20) and MNO (n = 20). Methods and Analyses: All rehabilitation treatments will consist of n°15 60 min-long rehabilitative sessions. Primary outcome measure will be upper limb motor function, assessed using the Fugl-Meyer Assessment scale for upper limb (FM-UL), collected at the baseline (T0), post-intervention (T1) and at follow-up (T2, 6-months after T1). Other outcome measures will be collected through a multidimensional evaluation including assessing stroke-associated quality of life, neurophysiological data, biomechanical and MRI measures. The innovative protocol will also be evaluated for usability and safety. Discussion: We expect to determine the efficacy, usability and safety of the AOT-NMES rehabilitation approach for the recovery of upper limb motor function in post-stroke patients. The obtained results will also help reveal the neural underpinnings of motor recovery, as assessed by neurophysiological data, biomechanical and MRI measures.https://doi.org/10.1177/11795735251331511
spellingShingle Monia Cabinio
Tiziana Lencioni
Arturo Nuara
Federica Rossetto
Valeria Blasi
Gaia Bailo
Rebecca Cardini
Rita Bertoni
Alessandro Viganò
Mariangela Bianco
Angela Comanducci
Pietro Avanzini
Maurizio Ferrarin
Luca Fornia
Francesca Baglio
Efficacy of a Rehabilitation Treatment Using Action Observation Therapy Enhanced by Muscle Synergy-Derived Electrical Stimulation (OTHELLO) in Post-Stroke Patients: A RCT Study Protocol
Journal of Central Nervous System Disease
title Efficacy of a Rehabilitation Treatment Using Action Observation Therapy Enhanced by Muscle Synergy-Derived Electrical Stimulation (OTHELLO) in Post-Stroke Patients: A RCT Study Protocol
title_full Efficacy of a Rehabilitation Treatment Using Action Observation Therapy Enhanced by Muscle Synergy-Derived Electrical Stimulation (OTHELLO) in Post-Stroke Patients: A RCT Study Protocol
title_fullStr Efficacy of a Rehabilitation Treatment Using Action Observation Therapy Enhanced by Muscle Synergy-Derived Electrical Stimulation (OTHELLO) in Post-Stroke Patients: A RCT Study Protocol
title_full_unstemmed Efficacy of a Rehabilitation Treatment Using Action Observation Therapy Enhanced by Muscle Synergy-Derived Electrical Stimulation (OTHELLO) in Post-Stroke Patients: A RCT Study Protocol
title_short Efficacy of a Rehabilitation Treatment Using Action Observation Therapy Enhanced by Muscle Synergy-Derived Electrical Stimulation (OTHELLO) in Post-Stroke Patients: A RCT Study Protocol
title_sort efficacy of a rehabilitation treatment using action observation therapy enhanced by muscle synergy derived electrical stimulation othello in post stroke patients a rct study protocol
url https://doi.org/10.1177/11795735251331511
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