NCT05147077

Integrated Rehabilitation in Treating Post-stroke Anxiety

Integrated Rehabilitation in Treating Post-stroke Anxiety: Study Protocol for a Multicentre, Prospective, Randomised, Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University · Academic / Other
• Sex: All
• Age: 25 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Post-stroke anxiety (PSA) is a common complication of stroke that leads to dysfunction and reduces the quality of life. PSA exacerbates cognitive dysfunction, delays the recovery process, and increases the disability, mortality, and recurrence rates of stroke. Therefore, early clinical treatments for PSA are important to improve the prognosis and restore the social functions of stroke patients. Integrated rehabilitation has significant advantages in the treatment of PSA. 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 PSA. 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.

Detailed description

This randomized controlled trial will enroll 188 PSA 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 anxiety (HAMA) scale, self-rating anxiety scale (SAS), 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).

Conditions

• Post-stroke
• Anxiety

Interventions

Type	Name	Description
PROCEDURE	Acupuncture	Acupuncture: Scalp acupuncture includes middle line of forehead (MS1), a front line by the forehead (MS2), and middle line of vertex (MS5), these acupoints are needled for 1 inch with the direction with scalp tilted 15-30 degrees. Body acupuncture includes Yintang (DU29), Taichong (LR3), Shenmen (HT7), Neiguan (PC6), Danzhong (RN17), Tongli (HT5), Xingjian (LR2). Traditional Chinese medicine Danzhixiaoyao Power: Danpi 10g, fried Zhizi 10g, Danggui 12g, Baishao 12g, fried Chaihu 6g, Fuling 10g, fried Baishu 10, roasted Gancao 3g. Repetitive transcranial magnetic stimulation The CCY-I magnetic field stimulator from Wuhan Irid Medical Equipment New Technology Co is used, with a frequency of 1Hz. Standard care The same as the standard care group.

Timeline

• Start date: 2022-01-24
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-12-07
• Last updated: 2022-06-27

Locations

1 site across 1 country: China