Japan’s public health insurance system has started covering the use of Cyberdyne Inc.’s Hybrid Assistive Limb, commonly known as HAL, to assist people with mobility problems. It is hoped that HAL will open up a new horizon in the field of medical rehabilitation. The development of this kind of technology that helps people with physical difficulties is especially important as the nation faces the serious challenge of having a rapidly aging population.
Yoshiyuki Sankai, a robotics engineer and professor at the University of Tsukuba’s Graduate School of Systems and Information Engineering, began forming the basic principles of the powered exoskeleton in 1991 by taking a cue from the fictional concept of a cyborg — a person that has physiological functions enhanced by mechanical or electronic devices, often integrated with its nervous system. He built the prototype in 1997 and founded Cyberdyne, a venture enterprise, in Tsukuba, Ibaraki Prefecture, in 2004 to promote the robotic suit.
To move limbs, the brain generates bioelectric signals that then travel through a neural network to specific muscles. The robotic suit, designed for the lower body, senses the faint signals in the skin and its motors immediately provide added power to the muscles that accomplish the intended movement. Thus it can help the disabled and the elderly stand up, sit down or walk. By being in between the cerebral nerve system and the muscles, the robot controls itself by processing information from sensors and acts as if it were part of the body.
The Pharmaceuticals and Medical Devices Agency recognized HAL as a medical device last November and the Health, Labor and Welfare Ministry’s Central Social Insurance Medical Council decided in January to cover the use of HAL for medical rehabilitation under the public health insurance system beginning this month. This represented the first case of a robotic suit covered by public health insurance.
Cybderyne, for which Sankai serves as CEO, manufactures and sells HAL in several variations. The use of welfare-type HAL, designed to improve the quality of life for disabled or aged people, started in 2010 and about 500 units have so far been sold. But the development of a model for medical rehabilitation was not easy because of strict regulations. Its safety and efficacy as a medical device had to be tested and proven.
Clinical trials of the medical model were carried at nine hospitals with doctors leading the trials. These trials demonstrated that patients suffering from hard-to-cure diseases that affect their nerves or muscles who used the robotic suit nine times were able to walk longer distances than they could without the device and the progress of their diseases slowed.
That the powered exoskelton was able to alleviate the physical damage caused by hard-to-cure diseases is a significant step forward. Sankai said that persistent use of HAL to move paralyzed limbs might allow regeneration of the network between the nervous and musculoskeltal systems pertaining the use of legs.
The health ministry, with an eye on showcasing HAL as a prime example of a Japanese technological breakthrough, put the robotic suit on the fast track for approval for coverage under the public health insurance program. For now, its use under the health insurance will be limited to an estimated 3,400 patients suffering from eight intractable diseases, including amyotrophic lateral sclerosis, spinal muscular atrophy, muscular dystrophy, congenital myopathy and Charcot-Marie-Tooth disease. But there’s a good chance that its coverage under the insurance program will be widened to include spinal damage, cerebral stroke and other illnesses.
Since HAL is a device that incorporates a completely new technology, many things remain unknown, including its long-term efficacy. The clinical application should be carried out with utmost care to ensure it becomes a reliable and useful next-generation medical device. Medical workers should be fully trained to know how to properly use and maintain HAL. Doctors should try combining the use of HAL and drugs to try to enhance the effectiveness of treatments.
The use of HAL is not limited to Japan. It won approval as a medical device in Europe two years before it did in Japan. In Germany, its use is covered by publicly-administered labor accidents insurance. Approval by authorities in the United States is also expected in the near future.
HAL can also be used for purposes other than medical rehabilitation. A version worn around the waist to assist people with carrying heavy items is now in use. The technology has great potential as a new industry, and to this end Cyberdyne is building a new manufacturing center in Koriyama, Fukushima Prefecture.
For earlier generations, robotic devices like HAL may have been the stuff of books and movies. The 1968 science fictional movie “2001: A Space Odyssey” started with a rebellion by artificial intelligence HAL9000 aboard a spacecraft. About a half century later, a robot with a similar name has begun to be used with the hope that it will play an important role in solving problems that confront society. Serious efforts should be made to expand the promising new horizon opened up by HAL.