Table 1 Trial registration data
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 |