Inclusion criteria | |
1. Within 1 month of a cerebrovascular event (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage). | |
2. With upper limb Brunnstrom stage (BRS) 2–4. | |
3. Aged 20 years or older at the time of obtaining informed consent. | |
4. Provides written informed consent to participate in this clinical study. | |
Exclusion criteria | |
1. Received treatments, such as botulinum therapy, repeated transcranial magnetic stimulation, and transcranial direct current stimulation, within 90 days of obtaining consent. | |
2. With a history of surgery (including device therapy) or intravenous t-PA for a cerebrovascular event (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage). | |
3. Cognitive decline (Mini-Mental State Examination (MMSE) is 21 or less). | |
4. Severe skin symptoms on the affected upper limb. | |
5. Have a history of epileptic seizures. | |
6. With a history of substance abuse or addiction (including alcoholism) at the time of enrolment and within the past year, or patients with complications. | |
7. Using an implantable cardiac stimulator, such as a cardiac pacemaker or an implantable assisted heart. | |
8. Using deep brain stimulation. | |
9. With metal (excluding titanium products) implanted in the affected upper limb. | |
10. Who are pregnant or may become pregnant. 11. Who are judged by doctors to be inappropriate as research subjects. | |
Discontinuation criteria | |
1. There was an offer to decline study participation or withdraw consent. | |
2. Who were found not to meet eligibility after enrolment. | |
3. The primary disease was completely cured and continued use was no longer necessary. | |
4. The device therapy used in this study was judged unfavorable due to exacerbation of the primary disease. | |
5. It is difficult to continue the study due to exacerbation of complications. | |
6. It is difficult to continue the study due to illness. | |
7. Although the frequency of use has been reduced according to the protocol, it is difficult to use even if the lower limit (less than 70% of the total planned number of uses) is reached. | |
8. Who became pregnant. | |
9. Poor compliance (if it is judged that less than 70% of the total planned number of uses will be used). | |
10. Who cannot receive intervention due to hospital transfer. | |
11. The entire study was discontinued | |
12. For other reasons, the doctor judged it appropriate to discontinue the study. |