PMID- 38020664 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231201 IS - 1664-2295 (Print) IS - 1664-2295 (Electronic) IS - 1664-2295 (Linking) VI - 14 DP - 2023 TI - Feasibility and safety study of wearable cyborg Hybrid Assistive Limb for pediatric patients with cerebral palsy and spinal cord disorders. PG - 1255620 LID - 10.3389/fneur.2023.1255620 [doi] LID - 1255620 AB - INTRODUCTION: 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 signed-rank 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 = 0.07). The improvements in the secondary outcomes were as follows: GMFM-66, 53.63 +/- 11.94 to 54.96 +/- 12.31, p = 0.04; step length, 0.32 +/- 0.16 to 0.34 +/- 0.16, p = 0.25; 2-MWD, 59.1 +/- 57.0 to 62.8 +/- 63.3, p = 0.54; COPM performance score, 3.7 +/- 2.0 to 5.3 +/- 1.9, p = 0.06; COPM satisfaction score, 3.3 +/- 2.1 to 5.1 +/- 2.1, p = 0.04. DISCUSSION: In this exploratory study, we applied a new size of wearable cyborg HAL (2S size), to children with central nervous system disorders. We evaluated its safety, feasibility, and identified an optimal assessment method for multiple treatments. All participants completed the protocol with no serious adverse events. This study suggested that the GMFM would be an optimal assessment tool for validation trials of HAL (2S size) treatment in pediatric patients with posture and motor function disorders. CI - Copyright (c) 2023 Takahashi, Mizukami, Watanabe, Kuroda, Shimizu, Nakajima, Mutsuzaki, Kamada, Tokeji, Hada, Koseki, Yoshikawa, Nakayama, Iwasaki, Kawamoto, Sankai, Yamazaki, Matsumura and Marushima. FAU - Takahashi, Kazushi AU - Takahashi K AD - Department of Physical Therapy, Ibaraki Prefectural University of Health Sciences Hospital, Ami, Japan. AD - Graduate School of Health Science, Ibaraki Prefectural University of Health Sciences, Ami, Japan. FAU - Mizukami, Masafumi AU - Mizukami M AD - Department of Physical Therapy, Ibaraki Prefectural University of Health Sciences, Ami, Japan. FAU - Watanabe, Hiroki AU - Watanabe H AD - Department of Neurosurgery, Institute of Medicine, University of Tsukuba, Tsukuba, Japan. FAU - Kuroda, Mayumi Matsuda AU - Kuroda MM AD - Department of Physical Therapy, Ibaraki Prefectural University of Health Sciences, Ami, Japan. FAU - Shimizu, Yukiyo AU - Shimizu Y AD - Department of Rehabilitation Medicine, Institute of Medicine, University of Tsukuba, Tsukuba, Japan. AD - Center for Cybernics Research, University of Tsukuba, Tsukuba, Japan. FAU - Nakajima, Takashi AU - Nakajima T AD - Department of Neurology, National Hospital Organization Niigata National Hospital, Kashiwazaki, Japan. FAU - Mutsuzaki, Hirotaka AU - Mutsuzaki H AD - Center for Medical Science, Ibaraki Prefectural University of Health Sciences, Ami, Japan. FAU - Kamada, Hiroshi AU - Kamada H AD - Department of Orthopaedic Surgery, Institute of Medicine, University of Tsukuba, Tsukuba, Japan. FAU - Tokeji, Kayo AU - Tokeji K AD - Department of Rehabilitation Medicine, Institute of Medicine, University of Tsukuba, Tsukuba, Japan. FAU - Hada, Yasushi AU - Hada Y AD - Department of Rehabilitation Medicine, Institute of Medicine, University of Tsukuba, Tsukuba, Japan. AD - Center for Cybernics Research, University of Tsukuba, Tsukuba, Japan. FAU - Koseki, Kazunori AU - Koseki K AD - Department of Physical Therapy, Ibaraki Prefectural University of Health Sciences Hospital, Ami, Japan. FAU - Yoshikawa, Kenichi AU - Yoshikawa K AD - Department of Physical Therapy, Ibaraki Prefectural University of Health Sciences Hospital, Ami, Japan. FAU - Nakayama, Tomohiro AU - Nakayama T AD - Department of Pediatric, Ibaraki Prefectural University of Health Sciences Hospital, Ami, Japan. FAU - Iwasaki, Nobuaki AU - Iwasaki N AD - Department of Pediatric Neurology, Tsuchiura Rehabilitation Hospital, Tsuchiura, Japan. FAU - Kawamoto, Hiroaki AU - Kawamoto H AD - Center for Cybernics Research, University of Tsukuba, Tsukuba, Japan. FAU - Sankai, Yoshiyuki AU - Sankai Y AD - Center for Cybernics Research, University of Tsukuba, Tsukuba, Japan. FAU - Yamazaki, Masashi AU - Yamazaki M AD - Department of Orthopaedic Surgery, Institute of Medicine, University of Tsukuba, Tsukuba, Japan. FAU - Matsumura, Akira AU - Matsumura A AD - Graduate School of Health Science, Ibaraki Prefectural University of Health Sciences, Ami, Japan. FAU - Marushima, Aiki AU - Marushima A AD - Department of Neurosurgery, Institute of Medicine, University of Tsukuba, Tsukuba, Japan. AD - Center for Cybernics Research, University of Tsukuba, Tsukuba, Japan. LA - eng PT - Journal Article DEP - 20231103 PL - Switzerland TA - Front Neurol JT - Frontiers in neurology JID - 101546899 PMC - PMC10656736 OTO - NOTNLM OT - Hybrid Assistive Limb OT - cerebral palsy OT - gait training OT - spinal cord disorder OT - wearable cyborg COIS- HKaw, AkM, and YSa are shareholders and directors in Cyberdyne Inc., which manufactures Wearable Cyborg HAL, and YSa is the CEO of CYBERDYNE. CYBERDYNE was not involved in the study design, data collection, analysis, writing, or submission of this article. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/11/29 18:42 MHDA- 2023/11/29 18:43 PMCR- 2023/11/03 CRDT- 2023/11/29 14:48 PHST- 2023/07/09 00:00 [received] PHST- 2023/10/24 00:00 [accepted] PHST- 2023/11/29 18:43 [medline] PHST- 2023/11/29 18:42 [pubmed] PHST- 2023/11/29 14:48 [entrez] PHST- 2023/11/03 00:00 [pmc-release] AID - 10.3389/fneur.2023.1255620 [doi] PST - epublish SO - Front Neurol. 2023 Nov 3;14:1255620. doi: 10.3389/fneur.2023.1255620. eCollection 2023.