Eye-acupuncture with rehabilitation therapy for stroke

BACKGROUND: Stroke survivors are accompanied by dysfunctions, greatly declining their activities of daily living and bringing burden to families and societies. Although modern rehabilitation therapy has a systematic program in post-stroke motor rehabilitation, numbers of patients still recover slowly. Eye-acupuncture (EA), as an important type of acupuncture, has been widely applied effectively in rehabilitation of stroke for about 50 years. So we combine EA with modern rehabilitation which has achieved successful results. Therefore, we need to adopt an objective and accurate evaluation method to study the effect of this method. METHODS: We aim to design a multi-center, block randomized, parallel control trial to assess the effect of eye-acupuncture combined with rehabilitation training therapy for patients with hemiplegia in the convalescent stage of stroke. 360 patients will be enrolled from 6 centres, with half of them (n = 180) in the control group (routine treatment group) and others (n = 180) in the experimental group (eye-acupuncture combined with routine treatment group). Stratified block randomization will be used in the study and the serial number 001-360 which corresponds to a participant will be assigned to each center randomly. We will use the sequentially sealed envelopes to hide the generating of assignment sequence. The cases of dropouts will be recorded with reasons. And the clinical CRFs will be filled in accurately, completely, and timely for statistical analysis. RESULTS: To verify the clinical effects, we will measure the change of bellows from visit 1 to visit 4. Primary outcomes: activity of daily living (ADL) scales (modified Barthel index); simple Fugl–Meyer motor function score; functional magnetic resonance imaging (fMRI) of the brain in the resting state. Secondary outcomes: traditional Chinese medicine (TCM) syndrome score scale; western aphasia battery (WAB); water swallow test; Montreal cognitive assessment (MoCA); growth-associated protein-43 (GAP-43); microtubule-associated protein-2 (MAP-2). CONCLUSION: The results of this study will provide present evidence on assessing effectiveness of EA combined with rehabilitation training for patients with hemiplegia in the convalescent stage of stroke. TRIAL REGISTRATION: This trial has been registrated in Chinese Clinical Trail Registry with the registration number as ChiCTR1900027835 (http://www.chictr.org.cn/).