ロボットスーツHALによるCybernic neurorehabilitation

抄録

The neuromuscular diseases affect commonly motor–unit that constitutes spinal motor neuron and/or muscle fiber. They develop incurable progressive amyotrophy and have patients bedridden. We aimed to assess the efficacy and safety of intermittent walk program using Cybernic exoskeleton robot, Hybrid Assistive Limb (HAL) for improvement of ambulatory dysfunction of them in an open–labelled multicenter randomized controlled crossover trial. This clinical trial suggested that Cybernic walk program using HAL had the same safety as the ordinary walk program with hoist. This trial also suggested that only 9 times of Cybernic walk program proved clinical efficacy for the neuromuscular disease. Our general hypothesis is that intention based errorless motor learning using HAL may improve walking dysfunction due to a variety of neurological disorders. We name it Cybernic neurorehabilitaion because this method can be regarded as one of neurorehabilitation programs based on both Hebbian theory and Edelman's neural group selection theory. We are thinking that Cybernic walk program which is combined with another etiological treatment using compounds, oligonucleotides, antibodies and stem cells may be important for the therapy of incurable progressive diseases in the future because neurorehabilitation process may be essential for functional recovery. The clinical study report of this trial and summary technical document have been successfully reviewed by Japanese authority, Pharmaceutical and Medical Devices Agency. HAL–HN01 (ML05) has been approved as a new medical device by Ministry of Health Labor and Welfare on the 25th of November 2015.