Safety and Selection Criteria of Single-joint Hybrid Assistive Limb for Upper Limb Paralysis After Stroke: A Phase I Trial
Robotic rehabilitation is a high-intensity intervention for upper limb paralysis after a stroke. This study explored the safety and feasibility of using a single-joint hybrid assistive limb (HAL-SJ) exoskeletal device for upper limb paralysis in patients with acute stroke. In total, 11 patients with...
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| Format: | Article |
| Language: | English |
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The Japan Neurosurgical Society
2025-01-01
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| Series: | Neurologia Medico-Chirurgica |
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| Online Access: | https://www.jstage.jst.go.jp/article/nmc/65/1/65_2024-0137/_pdf/-char/en |
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| _version_ | 1823861007740567552 |
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| author | Hiroshi OHMAE Taku MATSUDA Maki FUJIMOTO Yuka NAKANOWATARI Megumi YAMADA Nori SATO Kimiko UMEMURA Ryoma MORIGAKI Tetsuya MATSUURA Yasushi TAKAGI |
| author_facet | Hiroshi OHMAE Taku MATSUDA Maki FUJIMOTO Yuka NAKANOWATARI Megumi YAMADA Nori SATO Kimiko UMEMURA Ryoma MORIGAKI Tetsuya MATSUURA Yasushi TAKAGI |
| author_sort | Hiroshi OHMAE |
| collection | DOAJ |
| description | Robotic rehabilitation is a high-intensity intervention for upper limb paralysis after a stroke. This study explored the safety and feasibility of using a single-joint hybrid assistive limb (HAL-SJ) exoskeletal device for upper limb paralysis in patients with acute stroke. In total, 11 patients with stroke (6 with moderate paralysis and 5 with severe paralysis) were enrolled between October 2021 and October 2023 in a stroke care unit. The patients underwent HAL training 3 times a week for 6 sessions. No serious adverse events related to HAL-SJ occurred, and participants demonstrated significant improvements in the Fugl-Meyer Assessment Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT) (pre- vs. post-intervention; p < 0.05). The minimal clinically important difference (MCID) for FMA-UE was surpassed in 5 patients (83.3%) with moderate paralysis and 2 (40.0%) with severe paralysis. Regarding ARAT, 4 patients (66.7%) with moderate paralysis exceeded the MCID, whereas none (0.0%) with severe paralysis did. These findings suggest that HAL-SJ is both safe and feasible, particularly for individuals with moderate paralysis. |
| format | Article |
| id | doaj-art-0d6cfa922c244bd381e5195e7e4c6692 |
| institution | Kabale University |
| issn | 1349-8029 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | The Japan Neurosurgical Society |
| record_format | Article |
| series | Neurologia Medico-Chirurgica |
| spelling | doaj-art-0d6cfa922c244bd381e5195e7e4c66922025-02-10T05:22:30ZengThe Japan Neurosurgical SocietyNeurologia Medico-Chirurgica1349-80292025-01-01651152110.2176/jns-nmc.2024-01372024-0137Safety and Selection Criteria of Single-joint Hybrid Assistive Limb for Upper Limb Paralysis After Stroke: A Phase I TrialHiroshi OHMAE0Taku MATSUDA1Maki FUJIMOTO2Yuka NAKANOWATARI3Megumi YAMADA4Nori SATO5Kimiko UMEMURA6Ryoma MORIGAKI7Tetsuya MATSUURA8Yasushi TAKAGI9Division of Rehabilitation, Tokushima University HospitalDepartment of Neurosurgery, Institute of Biomedical Sciences, Graduate School of Medicine, Tokushima UniversityDivision of Rehabilitation, Tokushima University HospitalDivision of Rehabilitation, Tokushima University HospitalDivision of Rehabilitation, Tokushima University HospitalDepartment of Rehabilitation Medicine, Tokushima University HospitalDepartment of Rehabilitation Medicine, Tokushima University HospitalDepartment of Neurosurgery, Institute of Biomedical Sciences, Graduate School of Medicine, Tokushima UniversityDepartment of Rehabilitation Medicine, Tokushima University HospitalDepartment of Neurosurgery, Institute of Biomedical Sciences, Graduate School of Medicine, Tokushima UniversityRobotic rehabilitation is a high-intensity intervention for upper limb paralysis after a stroke. This study explored the safety and feasibility of using a single-joint hybrid assistive limb (HAL-SJ) exoskeletal device for upper limb paralysis in patients with acute stroke. In total, 11 patients with stroke (6 with moderate paralysis and 5 with severe paralysis) were enrolled between October 2021 and October 2023 in a stroke care unit. The patients underwent HAL training 3 times a week for 6 sessions. No serious adverse events related to HAL-SJ occurred, and participants demonstrated significant improvements in the Fugl-Meyer Assessment Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT) (pre- vs. post-intervention; p < 0.05). The minimal clinically important difference (MCID) for FMA-UE was surpassed in 5 patients (83.3%) with moderate paralysis and 2 (40.0%) with severe paralysis. Regarding ARAT, 4 patients (66.7%) with moderate paralysis exceeded the MCID, whereas none (0.0%) with severe paralysis did. These findings suggest that HAL-SJ is both safe and feasible, particularly for individuals with moderate paralysis.https://www.jstage.jst.go.jp/article/nmc/65/1/65_2024-0137/_pdf/-char/enstrokeroboticsrehabilitationsafetyupper extremity |
| spellingShingle | Hiroshi OHMAE Taku MATSUDA Maki FUJIMOTO Yuka NAKANOWATARI Megumi YAMADA Nori SATO Kimiko UMEMURA Ryoma MORIGAKI Tetsuya MATSUURA Yasushi TAKAGI Safety and Selection Criteria of Single-joint Hybrid Assistive Limb for Upper Limb Paralysis After Stroke: A Phase I Trial Neurologia Medico-Chirurgica stroke robotics rehabilitation safety upper extremity |
| title | Safety and Selection Criteria of Single-joint Hybrid Assistive Limb for Upper Limb Paralysis After Stroke: A Phase I Trial |
| title_full | Safety and Selection Criteria of Single-joint Hybrid Assistive Limb for Upper Limb Paralysis After Stroke: A Phase I Trial |
| title_fullStr | Safety and Selection Criteria of Single-joint Hybrid Assistive Limb for Upper Limb Paralysis After Stroke: A Phase I Trial |
| title_full_unstemmed | Safety and Selection Criteria of Single-joint Hybrid Assistive Limb for Upper Limb Paralysis After Stroke: A Phase I Trial |
| title_short | Safety and Selection Criteria of Single-joint Hybrid Assistive Limb for Upper Limb Paralysis After Stroke: A Phase I Trial |
| title_sort | safety and selection criteria of single joint hybrid assistive limb for upper limb paralysis after stroke a phase i trial |
| topic | stroke robotics rehabilitation safety upper extremity |
| url | https://www.jstage.jst.go.jp/article/nmc/65/1/65_2024-0137/_pdf/-char/en |
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