Effectiveness of Enhanced External Counterpulsation for Post-acute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale (MRS)
研究概览
简要总结
The goal of this clinical trial is to learn if there benefits combine enhanced external counterpulsation (EECP) with the standard post-acute care (PAC) rehabilitation treatment to treat stroke patients.. The main questions it aims to answer are:
What is the feasibility of combining EECP and PAC? Does EECP combined PAC rehabilitation improve functional outcomes of post-stroke patients? Researchers will compare standard PAC rehabilitation and EECP combined PAC rehabilitation to see if EECP has benefits to treat stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute cerebrovascular disease, within 1 month after acute attack.
- •Stable medical condition: (1). Neurological condition: The neurological condition has not deteriorated for more than 72 hours. (2). Vital signs including blood pressure, heartbeat, and body temperature are stable or controllable for more than 72 hours. (3). No complications such as infection, blood abnormalities, gastrointestinal bleeding, or stable or controllable after treatment.
- •Those whose functional status is moderate to moderately severe functional impairment (MRS 3-4) and who are judged by the medical team to have active rehabilitation potential: (1). Have basic cognition, learning ability and willingness. (2) Have sufficient physical strength: able to maintain a sitting position on a wheelchair or bed edge for at least one hour with support. (3). Be able to actively participate in rehabilitation treatment plans.
- •Aged over 20 years old
排除标准
- •Patients with atrial fibrillation/arrhythmia.
- •Within 2 weeks after cardiac catheterization or arterial puncture at the femoral artery puncture site.
- •Decompensated heart failure (NYHA class 3 or 4).
- •Left ventricular ejection fraction (EF) < 30%.
- •Moderate or severe aortic regurgitation.
- •Persistent and uncontrolled hypertension (blood pressure persistently >160/100 mmHg).
- •Bleeding tendency.
- •Active phlebitis/venous disease of the lower extremities.
- •Severe vascular occlusive disease of the lower extremities.
- •The presence of documented aortic aneurysm/dissection requiring surgical repair.
- •Pregnancy.
结局指标
主要结局
Modified Rankin Scale (MRS)
时间窗: 0, 3, 6, 9 weeks
A 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. It is used to categorize level of functional independence with reference to pre-stroke activities. Activity limitations are difficulties in performance of activities.It can be documented by the physician/APN/PA, nurse (RN), medical assistant, or any individual trained to perform the mRS.
Barthel Activity Daily Living Index
时间窗: 0, 3, 6, 9 weeks
The Barthel Index-based Supplementary Scales assesses basic activities of daily living using three scales:actual performance, ability, and self-perceived difficulty. The score ranges the three scales (i.e., actual performance, ability, and self-perceived difficulty)is 0-20, 0-18, and 0-20, respectively. A higher score indicates better basic activities of daily living.
Lawton-Brody Instrumental Activity Daily Living scale
时间窗: 0, 3, 6, 9 weeks
It consists of 8 questions including information about telephone use, meal preparation, shopping, doing daily household chores, laundry, getting on transportation, traveling, medication use and management of finances.
Functional Oral Intake Scale
时间窗: 0, 3, 6, 9 weeks
The Functional Oral Intake Scale (FOIS) is a reliable and valid tool for assessing functional oral food and fluid intake in patients with oropharyngeal dysphagia (OD). Fois has seven levels, with higher levels indicating better swallowing function.
Mini Nutrition Assessment
时间窗: 0, 3, 6, 9 weeks
questionnaire score (maximum score 30): total score \> 23.5 = normal nutritional status; total score \< 23.5 = inadequate nutritional status
EuroQol Five Dimensions Questionnaire (EQ-5D)
时间窗: 0, 3, 6, 9 weeks
EuroQol Five Dimension 5-level (validated measure for health-related quality of life). This is a validated measure of health-related quality of life (HRQoL) (see references). Subjects are asked to rate the level of problems they experience related to 5 domains of HRQoL (mobility, self care, usual activities, pain/discomfort and anxiety/depression). There are 5 values to choose from in each domain (e.g. no problem, slight problem, moderate problem, severe problem, unable to). A higher score indicates a worse quality of life. EQ-5D scores are converted to overall utilities by averaging domains and weighting by the general public's valuation of the domains. A higher overall utility score for EQ-5D represents better HRQoL.
Berg Balance Scale (BBS)
时间窗: 0, 3, 6, 9 weeks
A testing tool with high validity ( 0.93) and reliability (0.98) was used to measure balance in the elderly. The Berg Balance Scale (BBS) is a valid tool. The total score for the BBS is 56 and a higher score means good balance. It will be measured at baseline, 4th week and 8th week.
Gait speed
时间窗: 0, 3, 6, 9 weeks
m/s
Mini Mental State Examination
时间窗: 0, 3, 6, 9 weeks
The Mini Mental State Examination general cognitive function. The score ranges is 0 to 30. A higher score indicates better general cognitive function.
Short Portable Mental Status Questionnaire (SPMSQ)
时间窗: 0, 3, 6, 9 weeks
Based on psychiatric examination using the Indonesian SPMSQ to determine patient's cognitive status. An SPMSQ test in which the patient demonstrated more than 3 mistakes implies mild cognitive impairment, whereas a mistake of greater than 8 implies dementia.
Fugl-Meyer Assessment
时间窗: 0, 3, 6, 9 weeks
The Fugl-Meyer Assessment scale is an index to assess the sensorimotor impairment in individuals who have had stroke. The score ranges is 0 to 226. A higher score indicates better body function.
Motor Activity Log
时间窗: 0, 3, 6, 9 weeks
The Motor Activity Log (MAL) is a semistructured interview for hemiparetic stroke patients to assess the use of their paretic arm and hand (amount of use \[AOU\]) and quality of movement \[QOM\]) during activities of daily living. Scores range from 0 to 5.
Albert's Test
时间窗: 0, 3, 6, 9 weeks
Albert's Test is is screening tool used to detect the presence of unilateral spatial neglect (USN) in patients with stroke. Patients cross out lines ruled in a standard fashion on a sheet of paper.
Canadian Occupational Performance Measure
时间窗: 0, 3, 6, 9 weeks
It is a semi-structured scale that helps to identify problematic areas of performance experienced by individuals and to measure their perceived occupational performance and satisfaction. This scale assesses the level of performance of self-care, productivity and leisure and satisfaction with these performances as perceived by the individual.
次要结局
- ankle-brachial index(0 and 9 weeks)