Effects of integrated action and sensory observation therapy based on mirror neuron and embodied cognition theory on upper limb sensorimotor function in chronic stroke: a study protocol for a randomised controlled trial

Abstract

Introduction This study protocol aims to explore the effectiveness and neural mechanism of the integration of action observation therapy (AOT) and sensory observation therapy (SOT) for post-stroke patients on upper limb sensorimotor function.Methods and analysis This is a single-centre, single-blind, randomised controlled trial. A total of 69 patients with upper extremity hemiparesis after stroke will be recruited and randomly divided into an AOT group, a combined action observation and somatosensory stimulation therapy (AOT+SST) group, and a combined AOT and SOT (AOT+SOT) group in a 1:1:1 ratio. Each group will receive 30 min of daily treatment, five times weekly for 4 weeks. The primary clinical outcome will be the Fugl-Meyer Assessment for Upper Extremity. Secondary clinical outcomes will include the Box and Blocks Test, modified Barthel Index and sensory assessment. All clinical assessments and resting-state functional MRI and diffusion tensor imaging data will be obtained at pre-intervention (T1), post-intervention (T2) and 8 weeks of follow-up (T3).Ethics and dissemination The trial was approved by the Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Chinese Traditional Medicine (Grant No. 2020-178). The results will be submitted to a peer-review journal or at a conference.Trial registration number ChiCTR2000040568