| Presentation | 2021-08-20 A Preliminary Study on Scientific and Feasible Clinical Evaluation Methods for Assistive Products Satoshi Shirogane, |
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| PDF Download Page |  PDF download Page Link |
| Abstract(in Japanese) | (See Japanese page) |
| Abstract(in English) | As the growing field of assistive devices for people with disabilities and the elderly, the expectations of identifying and validating evidence is thriving on contribution to the decisions about clinical use and the application of related welfare systems. However, due to the facts including diversity of the subject's disability, environment of assistive device usage, and others, it seems hard to practice large-scale group comparative studies such as randomized controlled trials (RCTs). In fact, a survey of peer-reviewed articles related to the evaluation of assistive devices indicated that there were few large-scale trials, with RCT studies accounting for only about 5% of the total. In the field of development of drugs and medical devices for rare diseases, which have similar problems, guidelines were published to enhance scientificity with a small number of subjects. Although being not easy to implement the recommended methods into practice, and it was considered even more difficult to deal with highly individualized cases such as developmental disorders. Meanwhile, in the field of epidemiology, an n-of-1 study design was proposed to examine causal relationships in individuals, and the design seemed to be more suitable for highly individualized cases than group comparison studies. The applicability of the design to clinical evaluation will be discussed in the future. |
| Keyword(in Japanese) | (See Japanese page) |
| Keyword(in English) | Assistive technology / Welfare equipment / Clinical trials / N-of-1 trials / Evidence |
| Paper # | WIT2021-16 |
| Date of Issue | 2021-08-13 (WIT) |
| Conference Information | |
| Committee | WIT |
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| Conference Date | 2021/8/20(1days) |
| Place (in Japanese) | (See Japanese page) |
| Place (in English) | Online |
| Topics (in Japanese) | (See Japanese page) |
| Topics (in English) | |
| Chair | Shinji Sakou(Nagoya Inst. of Tech.) |
| Vice Chair | Tomohiro Amemiya(Univ. of Tokyo) |
| Secretary | Tomohiro Amemiya(Saitama Industrial Tech. Center) |
| Assistant | Minako Hosono(AIST) / Aki Sugano(Nagoya Univ.) / Tomoyasu Komori(NHK) |
| Paper Information | |
| Registration To | Technical Committee on Well-being Information Technology |
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| Language | JPN |
| Title (in Japanese) | (See Japanese page) |
| Sub Title (in Japanese) | (See Japanese page) |
| Title (in English) | A Preliminary Study on Scientific and Feasible Clinical Evaluation Methods for Assistive Products |
| Sub Title (in English) | Towards dealing with highly individualized cases such as developmental disorders |
| Keyword(1) | Assistive technology |
| Keyword(2) | Welfare equipment |
| Keyword(3) | Clinical trials |
| Keyword(4) | N-of-1 trials |
| Keyword(5) | Evidence |
| 1st Author's Name | Satoshi Shirogane |
| 1st Author's Affiliation | National Rehabilitation Center for Parsons with Disabilities(National Rehabilitation Center for Parsons with Disabilities) |
| Date | 2021-08-20 |
| Paper # | WIT2021-16 |
| Volume (vol) | vol.121 |
| Number (no) | WIT-142 |
| Page | pp.pp.17-22(WIT), |
| #Pages | 6 |
| Date of Issue | 2021-08-13 (WIT) |