Integrated Rehabilitation in Treating Post-stroke Depression: Study Protocol for a Multicentre, Prospective, Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Change in self-rating depression scale (SDS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of cerebral infarction or cerebral hemorrhage with depression disorder, the type of depression and the clinical syndrome of liver qi stagnation;
- •Patients with clear consciousness, stable vital signs, ability to understand and cooperate with instructions, barthel index (BI) > 20, FMA (0-95), Mini-mental State Examination (MMSE) meet the following criteria: illiterate > 17, primary school level > 20, secondary school level (including technical secondary school) > 22, and college level (including junior college) > 23 points;
- •25 <= age <= 85 years, male or female;
- •First episode of stroke, no personal or family history of mental disability before the stroke;
- •Depression level as mild or moderate (HAMD scores >= 7 and <= 24);
- •Depression symptoms occur after the stroke in a clear temporal sequence;
- •The course of the PSD is limited to 2 weeks to 36 months after the stroke;
- •Participants can understand the study protocol and written informed consent is signed.
排除标准
- •Patients with acute brain trauma, brain infection, effusion, or tumor occupation;
- •There are intracranial metals and other foreign bodies (such as orthopedic materials, arterial clips, etc.), cardiac pacemakers, deep brain stimulators, and other electronic devices;
- •Previous seizures, including primary and secondary seizures；
- •Patients have severe complications in cardiovascular, liver, kidney or psychiatric history ;
- •There is a significant cognitive impairment (MMSE: literacy <= 17, primary school level <= 20, secondary school level (including technical secondary school) <= 22, and college level (including junior college) <= 23 points) or hearing impairment, aphasia;
- •Coma, dying or chronic illness;
- •Patients have taken psychotropic drugs or been treated for depression for nearly a month;
- •People with unstable vital signs or patients with other mental disorders.
结局指标
主要结局
Change in self-rating depression scale (SDS)
时间窗: Baseline, at 4-week during treatment, at 8-week follow-up
Self-Rating Depression Scale (SDS) Description. This self-report scale was designed to quantify the severity of current major depression in 20 items. The scale was tested for psychometric properties. Various studies showed good to adequate results for validity.
Change in hamilton depression (HAMD) scale
时间窗: Baseline, at 4-week during treatment, at 8-week follow-up
Based on this large study of psychiatric outpatients with major depressive disorder we recommend the following severity ranges for the HAMD: no depression (0-7); mild depression (8-16); moderate depression (17-23); and severe depression (≥24). Severity classification on the Hamilton Depression Rating Scale J Affect Disord.
Change in activity of daily living (ADL) scale
时间窗: Baseline, at 4-week during treatment, at 8-week follow-up
The Activities of Daily Living are a series of basic activities necessary for independent living at home or in the community. They are performed on a daily basis. There are many variations on the definition of the ADLs, but most organizations agree there are 5 basic categories. The Activities of Daily Living are a series of basic activities necessary for independent living at home or in the community. They are performed on a daily basis. There are many variations on the definition of the ADLs, but most organizations agree there are 5 basic categories.
次要结局
- Change in montreal cognitive assessment (MoCA) scale(Baseline, at 4-week during treatment, at 8-week follow-up)
- Change in the simple fugl-meyer assessment of motor function (FMA) scale(Baseline, at 4-week during treatment, at 8-week follow-up)
- Change in pittsburgh sleep quality index (PSQI)(Baseline, at 4-week during treatment, at 8-week follow-up)
研究者
Hong Gao
Deputy dean
The Third Affiliated hospital of Zhejiang Chinese Medical University