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Clinical Trial Summary

Post-stroke depression (PSD) is a common complication of stroke that leads to dysfunction and reduces the quality of life. PSD exacerbates cognitive dysfunction, delays the recovery process, and increases the disability, mortality and recurrence rates of stroke. Therefore, early clinical treatments for PSD are important to improve the prognosis and restore the social functions of stroke patients. Integrated rehabilitation has significant advantages in the treatment of PSD. First of all, there is a wide range of rehabilitation methods, such as acupuncture, traditional Chinese medicine, and repetitive transcranial magnetic stimulation, which have been proved to be effective for PSD. However, as the application of integrated rehabilitation becomes more and more widespread, its shortcomings are gradually emerging. For example, most of the treatment protocols used in clinical studies are based on personal experience of the investigators, a unified protocol has not yet been formed; treatment methods are still insufficient in standardization and reproducibility. More studies focus solely on the improvement of a certain symptom by a certain rehabilitation therapy, but ignore the important theoretical basis of the "holistic concept", thus showing the uneven clinical efficacy. For the above existing problems, it is necessary to conduct original and innovative research.


Clinical Trial Description

This randomized controlled trial will enroll 202 PSD patients from the Third Affiliated Hospital of Zhejiang Chinese Medical University, Zhejiang General Hospital of Armed Police, Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University, and Jinhua Second Hospital. All patients will be randomly assigned to either the integrated rehabilitation group or the standard care group through a randomization system. The primary outcome will be assessed by hamilton depression (HAMD) scale, self-rating depression scale (SDS), and activity of daily living (ADL) scale. Secondary outcomes will include montreal cognitive assessment (MoCA) scale, the simple fugl-meyer assessment of motor function (FMA) scale and pittsburgh sleep quality index (PSQI). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05187975
Study type Interventional
Source The Third Affiliated hospital of Zhejiang Chinese Medical University
Contact Hong Gao
Phone +8618072982566
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 30, 2022
Completion date March 24, 2022

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