Effectiveness of robot-assisted virtual reality mirror therapy for upper limb motor dysfunction after stroke: study protocol for a single-center randomized controlled clinical trial.

Upper limb motor dysfunction is a common sequela of stroke, and its clinical efficacy needs to be improved. This protocol describes a trial to verify the clinical efficacy of robot-assisted virtual reality mirror therapy (RAVRMT) in improving upper limb motor dysfunction in stroke patients, and to explore the central mechanism by using functional magnetic resonance imaging (fMRI). This trial will be a single-center, assessor-blinded, randomized controlled clinical study. Thirty-two eligible patients will be randomly divided into 2 groups according to the ratio of 1:1, namely virtual reality mirror therapy (VRMT) group and robot-assisted virtual reality mirror therapy (RAVRMT) group. The interventions will be performed once a day for 4 weeks. Primary outcome is Fugl-Meyer motor function assessment-Upper Extremity (FMA-UE), secondary outcomes are the Montreal Cognitive Assessment (MoCA), activities of daily living (ADL), quality of life (QOL), the pain visual analogue scale (VAS-pain) and fMRI. Adverse events will be recorded, and severe adverse events will be used as criteria to discontinue the intervention. Combined application of robot-assisted therapy and virtual reality mirror therapy could theoretically activate mirror neuron system and reward circuits to a greater extent, but further high-quality research is needed. The results of this trial will determine whether RAVRMT could better improve upper limb motor dysfunction after stroke and explore its central mechanism using fMRI. This trial was prospectively registered at ClinicalTrials.gov (ChiCTR2200061721; 01 July 2022).

Wei D ，Hua XY ，Zheng MX ，Wu JJ ，Xu JG ... -  《BMC Neurology》

Effects of robot-assisted upper limb training combined with functional electrical stimulation in stroke patients: study protocol for a randomized controlled trial.

About 17-80% stroke survivors experience the deficit of upper limb function, which strongly influences their independence and quality of life. Robot-assisted training and functional electrical stimulation are commonly used interventions in the rehabilitation of hemiplegia upper extremities, while the effect of their combination remains unclear. The aim of this trial is to explore the effect of robot-assisted upper limb training combined with functional electrical stimulation, in terms of neuromuscular rehabilitation, compared with robot-assisted upper limb training alone. Individuals (n = 60) with the first onset of stroke (more than 1 week and less than 1 year after stroke onset) will be considered in the recruitment of this single-blinded, three-arm randomized controlled trial. Participants will be allocated into three groups (robot-assisted training combined with functional electrical stimulation group, robot-assisted training group, and conventional rehabilitation therapies group) with a ratio of 1:1:1. All interventions will be executed for 45 min per session, one session per day, 5 sessions per week for 6 weeks. The neuromuscular function of the upper limb (Fugl-Meyer Assessment of upper extremity), ability of daily life (modified Barthel Index), pain (visual analogue scale), and quality of life (EQ-5D-5L) will be assessed at the baseline, at the end of this trial and after 3 months follow-up. Two-way repeated measures analysis of variance will be used to compare the outcomes if the data are normally distributed. Simple effects tests will be used for the further exploration of interaction effects by time and group. Scheirer-Ray-Hare test will be used if the data are not satisfied with normal distribution. We expect this three-arm randomized controlled trial to explore the effectiveness of robot-assisted training combined with functional electrical stimulation in improving post-stroke upper limb function compared with robot-assisted training alone. Effect of upper limb robot on improving upper limb function after stroke, identifier: ChiCTR2300073279. Registered on 5 July 2023.

Yang X ，Fengyi W ，Yi C ，Lin Q ，Yang L ，Xize L ，Shaxin L ，Yonghong Y ... -  《Trials》

Using brain functional magnetic resonance imaging to evaluate the effectiveness of acupuncture combined with mirror therapy on upper limb function in patients with cerebral ischemic stroke: a study protocol for a randomized, controlled trial.

Xu M ，Lin R ，Luo J ，Tang C ，Wang S ，Wong J ，Wu M ，Huang J ，Shi P ，Gao A ，Bai Y ，Xie Y ，Luo J ，Yang Y ，Cui S ... -  《Trials》

Augmented efficacy of intermittent theta burst stimulation on the virtual reality-based cycling training for upper limb function in patients with stroke: a double-blinded, randomized controlled trial.

Chen YH ，Chen CL ，Huang YZ ，Chen HC ，Chen CY ，Wu CY ，Lin KC ... -  《Journal of NeuroEngineering and Rehabilitation》

Combined robot motor assistance with neural circuit-based virtual reality (NeuCir-VR) lower extremity rehabilitation training in patients after stroke: a study protocol for a single-centre randomised controlled trial.

Improving lower extremity motor function is the focus and difficulty of post-stroke rehabilitation treatment. More recently, robot-assisted and virtual reality (VR) training are commonly used in post-stroke rehabilitation and are considered feasible treatment methods. Here, we developed a rehabilitation system combining robot motor assistance with neural circuit-based VR (NeuCir-VR) rehabilitation programme involving procedural lower extremity rehabilitation with reward mechanisms, from muscle strength training, posture control and balance training to simple and complex ground walking training. The study aims to explore the effectiveness and neurological mechanisms of combining robot motor assistance and NeuCir-VR lower extremity rehabilitation training in patients after stroke. This is a single-centre, observer-blinded, randomised controlled trial. 40 patients with lower extremity hemiparesis after stroke will be recruited and randomly divided into a control group (combined robot assistance and VR training) and an intervention group (combined robot assistance and NeuCir-VR training) by the ratio of 1:1. Each group will receive five 30 min sessions per week for 4 weeks. The primary outcome will be Fugl-Meyer assessment of the lower extremity. Secondary outcomes will include Berg Balance Scale, Modified Ashworth Scale and functional connectivity measured by resting-state functional MRI. Outcomes will be measured at baseline (T0), post-intervention (T1) and follow-ups (T2-T4). 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. 2019-014). The results will be submitted to a peer-reviewed journal or at a conference. ChiCTR2100052133.

Zhou ZQ ，Hua XY ，Wu JJ ，Xu JJ ，Ren M ，Shan CL ，Xu JG ... -  《-》