Digital mirror therapy combined with repetitive peripheral magnetic stimulation for upper limb motor function in patients who had a stroke: protocol for a single-centre randomised controlled trial in China.

Abstract

Upper limb motor dysfunction after stroke is a leading cause of disability worldwide, resulting in a significant economic burden on society. Rehabilitation is a key strategy for improving this condition. Although studies have shown that digital mirror therapy and repetitive peripheral magnetic stimulation individually provide benefits, the effectiveness of their combination remains unclear. We are conducting a randomised controlled trial to evaluate the efficacy of combining digital mirror therapy with repetitive peripheral magnetic stimulation in treating upper limb motor dysfunction post-stroke, in order to meet the urgent clinical need for more effective treatment options. This is a single-blind randomised controlled trial. A total of 46 participants will be randomly assigned in a 1:1 ratio to either the digital mirror therapy combined with repetitive peripheral magnetic stimulation group or the repetitive peripheral magnetic stimulation group. Both groups will undergo the intervention protocol spanning four consecutive weeks. Assessments will be conducted at baseline and after 4 weeks of treatment. The primary outcome will be evaluated using the Fugl-Meyer Assessment for Upper Extremity score. Secondary outcomes include the Action Research Arm Test, Box and Block Test, Modified Barthel Index, Fugl-Meyer Assessment - Upper Extremity Sensory subscale, Modified Ashworth Scale, as well as pinch strength, grip strength and adverse events. Intention-to-treat analysis will be applied to all data, including missing or dropout data. The study was approved by the Ethics Committee of Quanzhou First Hospital on 23 September 2024 (2024K193). The final results of this study will be published in a peer-reviewed journal. ChiCTR2400092692.