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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| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
The Japan Neurosurgical Society
2025-01-01
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| Series: | Neurologia Medico-Chirurgica |
| Subjects: | |
| Online Access: | https://www.jstage.jst.go.jp/article/nmc/65/1/65_2024-0137/_pdf/-char/en |
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| Summary: | 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. |
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| ISSN: | 1349-8029 |