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Table 1 Inclusion, exclusion, and discontinuation criteria

From: Feasibility and acceptability of novel functional electronic stimulated rehabilitation application for treatment in patients with cerebrovascular disorders: the FRAT study protocol

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.