Power-Assisted Rehabilitation Device with Electrical Stimulation---Brige from Engineering to Clinical Trials

Stroke is one of the leading causes of disability in the developed countries especially with the approaching of aging society. Recent research has shown that early rehabilitation training using electrical stimulation (ES)-assisted cycling/cranking device incorporated with active movement has been the most effective protocol. Active exercise incorporated with ES can not only activate the affected limb but also enhance the brain re-organization, especially at early intervention time window. The brain reorganization can be further enhanced by extrinsic feedback and interaction to external cues such as given varied torque or speed. However, there is a lack of rehabilitation device on the bedside for the severely ill patient. In this project, an ES assisted cycling/cranking device with volitional EMG and ES-elicited muscle force biofeedback will be designed for early bedside training of stroke. Also, a power-assisted mode will be provided to assist the acute/subacute stroke patients whose muscles are usually too weak to propel the cycling/cranking ergometer and to provide resistance when the trained patients are gaining their muscle power. . The project of this year will be led by Prof. Shih-Ching Chen to continune the incoorperation of functional electrical stimulation assisted device with clinical trial. Prof. Shih-Ching Chen and Prof. Jia-Jin Chen have been cooperated for over 10 years with strong sense of mission together in hope to collaborate with ZMI Electronics, Ltd (傑邁) and Electrical Motor Technology Research Center (supervised by Prof. Tsai). The project including product design, regulatory preparation, prototype manufacturing is meant to develop a market directed medical device. The aim of the project this year contains going through the electrical safety of our device, finish the prototype of power assisted cycling device with electrical stimulation which is executed by ZMI. Meanwhile, there will be several clinical centers to accomplish the clinical trial. Prof. Shih-Ching Chen and Assistant Prof. Chih-Wei Peng to verify the treatment effect of developed product on gait and spasticity in stroke patients in Taipei Medical University Hospital. Chien-Chih Chen in Kaohsiung Medical University and Dr. Zheng-Yu Hoe in Kaohsiung Veterans General Hospital together verify the improvement of developed product to storke patient by Near-Infrared Spectroscopy and electromyography to assess the cycling performance and cortical plasiticity in central and perifereal nervous system aspect sapatrately. It is believed that strong academic publications, advanced engineering technology, solid clinical trials as well as excellent ICT production capability should pave the way to a successful medical device. These should attract the companies to further invest in medical device industry and enter incubation center of Biomedical Science Park. The proposed device can be extended for critically ill patients or as a homecare active exercise for elderly subjects with great market potentials.