Abstract: Objective: To analyze the artificial intelligence (AI) randomized controlled trial (RCT) researches published in PubMed, and explore the current situation of AI RCT researches and provide a reference for researchers to carry out related researches. Methods: AI RCTs researches were obtained by searching PubMed database, the Web of Science was used to obtain the publication year, journals, authors, organizations, and countries of included AI RCTs researches. The VOSviewer 1. 6. 17 software was used to extract the related information, and generate visual cooperation network maps for the country, organizations, citations, and authors, perform cluster analysis for keywords. The Cite Space 5. 8. R3 software was used to analyze the burst citation references and keywords. Results: A total of 1174 RCTs in AI field were included, and the number of articles increased rapidly after 2007; United States, Italy, and South Korea contributed the most publications; China ranks fifth in the number of publications and has formed good cooperative relations with the United States, Canada, and Italy; The three most contributed institutions are Harvard University of the United States, Yonsei University of Korea, and Northwestern University of the United States. Krebs, Calabro, and Picelli published the most literature; The main hot topics are the application of robot technology in treatment, the application of machine learning in disease diagnosis and management, and the application of AI in rehabilitation training. Combined with strongest citation burst, it can be seen that machine learning maybe the current research hot topic; The magazine International Journal of Neuroengineering and Rehabilitation (n=40, IF 2020=4.26) is the most productive journal; The paper with the highest number of citations and the strongest citations burst is RCT published in the New England Journal of medicine in 2010 by Albert et al, which analyzed the effect of robot-assisted treatment of long-term upper-limb injury after stroke. Conclusion: The authors, institutions, and countries of AI RCTs research should strengthen cooperation, and the research theme needs to be expanded. AI has great application prospects in the medical field, Chinese scholars should strengthen tracking the application trend of AI in the medical field, strengthen cooperation with foreign scientific research institutions, and provide more high-quality evidence for the clinical application of AI.