JMIR Publications

ABSTRACT

Background:

In the last few years, new non-invasive strategies have emerged as rehabilitative treatments after a stroke. The Action Observation Treatment (AOT) is a rehabilitation approach based on the properties of the Mirror Neuron System (MNS) with a positive impact in modifying cortical activation patterns and in improving the upper limb kinematics. AOT involves the dynamic process of observing purposeful actions with the intention of imitating and then practicing those actions. In the last years, several clinical studies have been published, suggesting the effectiveness of AOT in patients with stroke to improve motor recovery and autonomy in ADLs. However, a deeper knowledge of the behavior of the sensorimotor cortex during AOT seems to be essential.

Objective:

The aim of this clinical trial, conducted in two neurorehabilitation centers and in patients’ homes, is to deeply investigate the effectiveness of AOT on patients with stroke confirming the translational power of a tailored treatment. Particular emphasis will be placed to the possible predictive value of neurophysiological biomarkers. In addition, the feasibility and the impact of an AOT home-based program will be investigated.

Methods:

A three-arm, assessors-blinded, randomized controlled trial will be performed enrolling patients with stroke in chronic stage (i.e., >6 months from the first event). 60 subjects will be randomly allocated to receive 15 sessions of AOT with different protocols (AOT at the hospital, AOT at home, and sham AOT), three sessions per week, for 5 weeks. Primary outcome will be assessed with Fugl-Meyer Assessment-Upper Extremity scores. Secondary outcomes will be clinical, assessed using specific tests and clinical scales, kinematic and neurophysiological (i.e., EEG and EMG).

Results:

he study protocol is part of a project (Project Code GR-2016–02361678) approved by the Italian Minister of Health. Ethics Committees of both involved centers reviewed and approved the study protocol (IRCCS San Raffaele Roma, protocol code number: RP05/2018; Milano Area 2, protocol: 705_2018bis). The study began with the recruitment phase in January 2022, and enrollment is expected to end in October 2022. Recruitment is now closed. Results of the study are expected to be published in spring 2023. On completion of the analyses, we will examine the preliminary effectiveness of the intervention and the neurophysiological outcomes.

Conclusions:

This study will be used to evaluate the effectiveness of two different AOT scenarios (i.e., AOT at the hospital, AOT at home) in patients with chronic stroke, assessing also the predictive value of neurophysiological biomarkers. Specifically, we will try to induce a functional modification of the cortical components, exploiting the features of the MNS, demonstrating relevant clinical, kinematic, and neurophysiological changes after AOT. With our study, we also want to provide, for the first time in Italy, the AOT home-based program while assessing its feasibility and impact. Clinical Trial: ClinicalTrials.gov Identifier: NCT04047134.