Period | Screening | Treatment | Follow-up | ||||
---|---|---|---|---|---|---|---|
Items | Before enrolment (weeks) −2 to −1 | End of 2-week treatment (weeks) 3 | End of 4-week treatment (weeks) 5 | End of 6-week treatment (weeks) 7 | End of 6 weeks after the end of the treatment follow-up (weeks) 13 | End of 6 months after the onset time follow-up | |
Recruitment | X | ||||||
Enrolment | X | ||||||
Inclusion criteria | X | ||||||
Exclusion criteria | X | ||||||
Basic characteristic variables | X | ||||||
Randomization and allocation concealment | X | ||||||
Primary outcomes | Western Aphasia Battery | X | X | X | X | X | X |
Chinese Functional Communication Profile | X | X | X | X | X | X | |
Secondary outcomes | X | X | X | X | X | X | |
National Institute of Health Stroke Scale | X | X | X | X | X | X | |
Stroke and Aphasia Quality of Life Scale-39 | X | X | X | X | X | X | |
Stroke Specific Quality of Life Scale | X | X | X | X | X | X | |
Health Scale of Traditional Chinese Medicine | X | X | X | X | X | X | |
Adverse events recorded | X | X | X | ||||
Relapse | X | X | |||||
Self-reported drug therapy | X | X | X | X | X | ||
Compliance | X | X | X |