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Table 1 Trial registration data

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

Data category Information
Registration number ChiCTR1900026740
Date of last refreshed on October 22, 2019
Date of registration October 20, 2019
Registration status Prospective registration
Public title A randomized controlled trial for “Xing-Nao Kai-Qiao” Rehabilitation Program in the Treatment of Motor Aphasia after Stroke
Scientific title A randomized controlled trial for “Xing-Nao Kai-Qiao” Rehabilitation Program in the Treatment of Motor Aphasia after Stroke
The registration number of the Partner Registry AMCTR-IOR-19000302
Study leader Meng Zhihong
Study leader’s address 314 Wes Anshant Road, Nankai District, Tianjin, China
Approved no. of the ethics committee TYLL2019[K]word015
Primary sponsor The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Source(s) of funding Central government special funds
Target disease Aphasia after stroke
Study type Interventional study
Study design Parallel
Inclusion criteria (1) Meet the diagnostic criteria for motor aphasia after stroke; (2) aphasia appears for the first time after stroke; (3) onset time ranged from 15 days to 3 months; (4) the severity of aphasia is 0–3, which can be used in conjunction with speech training; (5) consciousness of consciousness and stable vital signs; (6) aged 45 to 75 years old; (7) patient or family signed an informed consent form and have a good compliance
Exclusion criteria (1) Combined with severe primary diseases such as liver, kidney, hematopoietic system, and endocrine system; (2) there are abnormalities in audio-visual, severe cognitive impairment, and mental illness, which cannot be combined with examination and treatment; (3) pregnant and lactating women
Recruiting time From October 21, 2019, to December 31, 2020
Countries of recruitment China
Primary outcomes Western Aphasia Battery; Functional Language Communication Capability Check
Secondary outcomes Boston Diagnostic Aphasia Examination; NIH Stroke Scale; SAQOL-39 Quality of Life Scale; Stroke-Specific Quality of Life Scale; the Health Scale of Traditional Chinese Medicine
Randomization procedure Stratified block randomization method
Blinding Open label
The time of sharing IPD Within 6 months after the trial complete
The way of sharing IPD Apply to the main researcher for publication