Design and Implementation of Wearable Cephalic Stimulator / 中国康复理论与实践

ABSTRACT

Objective:To design a type of wearable cephalic stimulator and verify its feasibility, safety and effectiveness. Methods:The wearable cephalic stimulator was designed based on transcranial electric stimulation and the meridian. From June 2015 to February 2018, 80 patients with ischemic stroke were randomly divided into control group (n = 40) and treatment group (n = 40). The control group accepted routine rehabilitation, and the treatment group was treated with the wearable cephalic stimulator additionally, for four weeks. They were assessed with Fugl-Meyer Assessment (FMA) and modified Barthel index (MBI) before and after treatment. While, the safety and stability of the device were observed, and the temperature, pulse, respiration, blood pressure, etc. of the patient were recorded. Results:The prototype was successfully produced. There was no significant difference in the scores of FMA and MBI between two groups before treatment (P > 0.05). The scores of FMA and MBI significantly increased in both groups (t > 2.448, P < 0.05), and they were higher in the observation group than in the control group (|t| > 2.202, P < 0.05) after treatment. The temperature, pulse, and breathing did not change during the treatment with this device, and blood pressure did not increase. Conclusion:The wearable cephalic stimulator is safe, reliable and operability, and could effectively improve the motor function and activities of daily living in patients with acute ischemic stroke.