AUTHOR=Takahashi Kazushi , Mizukami Masafumi , Watanabe Hiroki , Kuroda Mayumi Matsuda , Shimizu Yukiyo , Nakajima Takashi , Mutsuzaki Hirotaka , Kamada Hiroshi , Tokeji Kayo , Hada Yasushi , Koseki Kazunori , Yoshikawa Kenichi , Nakayama Tomohiro , Iwasaki Nobuaki , Kawamoto Hiroaki , Sankai Yoshiyuki , Yamazaki Masashi , Matsumura Akira , Marushima Aiki 

TITLE=Feasibility and safety study of wearable cyborg Hybrid Assistive Limb for pediatric patients with cerebral palsy and spinal cord disorders

JOURNAL=Frontiers in Neurology

VOLUME=Volume 14 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1255620

DOI=10.3389/fneur.2023.1255620

ISSN=1664-2295

ABSTRACT=The wearable cyborg Hybrid Assistive Limb (HAL) is the world's first cyborg-type wearable robotic device, and it assists the user's voluntary movements and facilitates muscle activities. However, since the minimum height required for using the HAL is 150 cm, a smaller HAL (2S size) has been newly developed for pediatric use. This study aimed to (1) examine the feasibility and safety of a protocol for treatments with HAL (2S size) in pediatric patients and (2) explore the optimal method for assessing the efficacy of HAL. Methods: This clinical study included seven pediatric patients with postural and motor function disorders, who received 8-12 sessions of smaller HAL (2S size) treatment. The primary outcome was the Gross Motor Function Measure-88 (GMFM-88). The secondary outcomes were GMFM-66, 10-m walk test, 2-and 6-min walking distances, Canadian Occupational Performance Measure (COPM), a post-treatment questionnaire, adverse events, and device failures. Statistical analyses were performed using the paired samples t-test or Wilcoxon signedrank test. Results: All participants completed the study protocol with no serious adverse events. GMFM-88 improved from 65.51±21.97 to 66.72±22.28 (P=0.