Abstract
The WHO definition of health as complete well-being is widely accepted. However, this definition has been criticized as being less feasible for incurable diseases and for the increase in chronic illnesses in ageing societies such as Japan. Therefore, this chapter refers to the alternative concept of health suggested by Huber et al. (2011) as the “ability to adapt and self-manage in the face of social, physical, and emotional challenges”. Accordingly, medical treatment could be interpreted as support for patients to adapt to certain disabilities instead of efforts towards normalization. The cyborg-type robot Hybrid Assistive Limb (HAL) developed by scientist Yoshiyuki Sankai as a device for motor learning is a medical treatment based on this alternative concept. Sankai’s innovation includes the concept of Cybernics, a term coined from cybernetics, mechatronics and informatics. Subsequently, a multi-institutional research group based at Niigata National Hospital in Kashiwazaki City performed a randomized clinical trial (NCY-3001) for gait treatment with HAL in patients with incurable neuromuscular diseases. The clinical trial found that the patients’ subjective evaluations, or patient-reported outcomes (PROs), should be strengthened as evidence of adaptation and improvement of symptoms.
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Notes
- 1.
The Orphan Drug Act is a mechanism to support the development of drugs and medical devices for rare diseases with public funds. The act, adopted in the United States in 1983, was established to address the disparity in funding for rare diseases. An almost identical act was adopted in Japan in 1993, in Australia in 1997 and in the EU in 1999.
- 2.
The author himself coordinated the whole clinical trial and functioned as principal investigator of the trial, NCY-3001, registered as JAM-IIA00156.
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I would like to thank Andrew P. Wood for his English-language assistance.
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Nakajima, T. (2021). Innovative Technology, Clinical Trials and the Subjective Evaluation of Patients: The Cyborg-type Robot HAL and the Treatment of Functional Regeneration in Patients with Rare Incurable Neuromuscular Diseases in Japan. In: Brucksch, S., Sasaki, K. (eds) Humans and Devices in Medical Contexts. Health, Technology and Society. Palgrave Macmillan, Singapore. https://doi.org/10.1007/978-981-33-6280-2_11
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