The traditional Chinese medicine rehabilitation for the post-stroke cognitive impairment will be intervened, which can promote the recovery of post-stroke cognitive function patients, reduce the disability rate and improve the quality of life.
This study will collect inpatients from April 2019 to December 2024 who from the third affiliated hospital of Zhejiang university of traditional Chinese medicine, Jiaxing hospital of traditional Chinese medicine, Hangzhou hospital of traditional Chinese medicine.this study sets strict time window (stroke recovery, 30-180 days), use multi-center, large sample, randomized controlled study method and the objective recognition rehabilitation evaluation criteria and efficacy evaluation system to evaluate the clinical effect and analysis of health economics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
122
Chinese traditional rehabilitation including acupuncture and herbs
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
Hangzhou hospital of traditional Chinese medicine
Hangzhou, Zhejiang, China
Jiaxing hospital of Chinese traditional medicine
Jiaxing, Zhejiang, China
Change of Cognitive function
Montreal Cognitive Assessment(MOCA) will be used, this method focus on the sensitivity and specificity of the scale for the recognition of cognitive impairment are high, and it is evaluated from visual spatial/executive function, language function, image ability orientation and so on. MoCA has a maximum score of 30 points. The normal scoring standard is a total score ≥ 26 points (for those with an education level ≤ 12 years, this standard is reduced by 1 point). Higher scores mean a better outcome.
Time frame: 0 week, 4 weeks, 8 weeks, 12 weeks, 16weeks
change in the scores of mini-Mental State Examination (MMSE)
The scale is used for rapid evaluation of orientation, memory, attention, calculation, language, and visuospatial structure. MMSE has a maximum score of 30 points. The normal cut-off values are: illiterate group ≥17 points, primary school group ≥20 points, middle school or higher group ≥24 points. Higher scores mean a better outcome.
Time frame: 0 week, 8 weeks, 12 weeks, 16 weeks
Changes in Daily Living ability
ADL(Activity of Daily Living) will be used, which also known as the Barthel Index, consists of 10 items, including toileting, grooming, using the toilet, eating, dressing, transferring, activities, going up and down stairs, and bathing). The total score ranges from 0 to 100. Higher scores mean a better outcome.
Time frame: 0 week, 8 weeks, 12 weeks, 16 weeks
Changes in depressive status
use Hamilton Depression Scale to evaluate depression, the score were 24 for severe, 17 for moderate and 7 for mild. Higher scores mean a worse outcome.
Time frame: 0 week, 8 weeks, 12 weeks and 16 weeks
Changes in the patterns of activation of brain regions related to cognitive impairment
ALLF, fALFF, PerAF, ReHo and DC were used to analyze the resting state functional magnetic resonance imaging. The pattern changes of relevant brain regions related to cognitive impairment after stroke were revealed.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 0 weeks, 8 weeks