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Table 2 Trial process chart

From: The efficacy and safety of acupuncture combined with language training for motor aphasia after stroke: study protocol for a multicenter randomized sham-controlled trial

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