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Paper Abstract and Keywords
Presentation 2021-08-20 14:45
A Preliminary Study on Scientific and Feasible Clinical Evaluation Methods for Assistive Products -- Towards dealing with highly individualized cases such as developmental disorders --
Satoshi Shirogane (National Rehabilitation Center for Parsons with Disabilities) WIT2021-16
Abstract (in Japanese) (See Japanese page) 
(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) 
(in English) Assistive technology / Welfare equipment / Clinical trials / N-of-1 trials / Evidence / / /  
Reference Info. IEICE Tech. Rep., vol. 121, no. 142, WIT2021-16, pp. 17-22, Aug. 2021.
Paper # WIT2021-16 
Date of Issue 2021-08-13 (WIT) 
ISSN Online edition: ISSN 2432-6380
All rights are reserved and no part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing from the publisher. Notwithstanding, instructors are permitted to photocopy isolated articles for noncommercial classroom use without fee. (License No.: 10GA0019/12GB0052/13GB0056/17GB0034/18GB0034)
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Conference Information
Committee WIT  
Conference Date 2021-08-20 - 2021-08-20 
Place (in Japanese) (See Japanese page) 
Place (in English) Online 
Topics (in Japanese) (See Japanese page) 
Topics (in English)  
Paper Information
Registration To WIT 
Conference Code 2021-08-WIT 
Language Japanese 
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)
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Speaker Author-1 
Date Time 2021-08-20 14:45:00 
Presentation Time 25 minutes 
Registration for WIT 
Paper # WIT2021-16 
Volume (vol) vol.121 
Number (no) no.142 
Page pp.17-22 
Date of Issue 2021-08-13 (WIT) 

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