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.

IF 2.6 Q2 CLINICAL NEUROLOGY
Journal of Central Nervous System Disease Pub Date : 2025-05-11 eCollection Date: 2025-01-01 DOI:10.1177/11795735251331511
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
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引用次数: 0

Abstract

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.

肌肉协同电刺激(OTHELLO)增强动作观察疗法对脑卒中后患者康复治疗的疗效:一项RCT研究方案。
背景:动作观察疗法(AOT)和神经肌肉电刺激(NMES)是脑卒中后患者上肢康复中广泛采用的技术。虽然AOT和NMES单独有效,但缺乏研究调查潜在的协同作用,以提高康复结果。目的:本研究旨在比较AOT和NMES联合应用(AOT-NMES)在单独AOT或单独运动中性观察治疗(MNO,不涉及AOT和NMES)对上肢运动功能恢复的肌肉协同作用的影响。设计:随机对照试验(RCT)纳入60例脑卒中后导致上肢残疾的患者,按1:1:1的比例随机分配到AOT- nmes (n = 20)、AOT (n = 20)和MNO (n = 20)三个介入组。方法和分析:所有康复治疗将包括n°15 60分钟的康复疗程。主要结局指标将是上肢运动功能,使用Fugl-Meyer上肢评估量表(FM-UL)评估,在基线(T0)、干预后(T1)和随访(T2, T1后6个月)收集数据。其他结果测量将通过多维评估收集,包括评估卒中相关的生活质量、神经生理数据、生物力学和MRI测量。该创新协议还将对可用性和安全性进行评估。讨论:我们期望确定AOT-NMES康复方法对脑卒中后患者上肢运动功能恢复的有效性、可用性和安全性。所获得的结果也将有助于揭示运动恢复的神经基础,通过神经生理学数据,生物力学和MRI测量进行评估。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
6.90
自引率
0.00%
发文量
39
审稿时长
8 weeks
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