The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial

Table 1 Study design

Items		Before intervention		Intervention period		Follow-up period
Items		Screening	Evaluate^a	Weeks 1-12	Evaluate^b	Weeks 13-36	Evaluate^c
Enrollment		×
Informed consent		×
Basic information		×
Inclusion and exclusion criteria		×
Randomization and allocation		×
Primary outcomes	MMSE	×	×		×		×
Secondary outcomes	MoCA		×		×		×
	TAP		×		×
	WMS		×		×
	TMT		×		×
	Stroop		×		×
	MBI		×		×		×
	SF-36		×		×		×
	FMA		×		×
	fMRI		×		×
	ERP		×		×
Treatment recorded				×		×
Adverse events recorded				×		×
Rehabilitation expenses questionnaire				×		×	×

^aEvaluation in the week before intervention. ^bEvaluation in the week after intervention. ^cEvaluation in the week after follow-up. Abbreviations: MMSE, Mini-Mental State Examination; MoCA, Montreal Cognitive Assessment; TAP, Test of attentional performance; WMS, Wechsler memory scale; TMT, Trail Making Test A and B; Stroop, Stroop Test; MBI, Modified Barthel Index; SF-36, 36-Item Short Form Health Survey; FMA, Fugl-Meyer Motor Assessment; fMRI, Functional magnetic resonance imaging; ERP, Event-related potentials

ISSN: 1745-6215