RecruitingNot ApplicableNCT06711003

Effectiveness of Enhanced External Counterpulsation for Post-acute Stroke Patients


Sponsor

China Medical University Hospital

Enrollment

110 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 20 Years

Inclusion Criteria4

  • 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

Exclusion Criteria11

  • 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.

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Interventions

DEVICEenhanced external counterpulsation

Enhanced External Counterpulsation (EECP) is a non-invasive treatment primarily used for patients with angina or heart failure. It involves the application of pressure cuffs to the legs, which inflate and deflate in sync with the cardiac cycle. This enhances blood flow to the heart during diastole, the phase when the heart is resting between beats. The increased pressure promotes coronary artery perfusion, helping to improve oxygen delivery to the heart muscle, reduce angina symptoms, and enhance cardiovascular function. EECP is typically recommended for patients who are not good candidates for invasive procedures like angioplasty or bypass surgery, or for those seeking supplementary treatment for angina. Over time, it may promote the development of new blood vessels (collateral circulation), further improving heart health. The treatment is generally administered over several weeks in outpatient settings, with each session lasting around one hour.

PROCEDUREpost acute care

Post-Acute Care (PAC) for stroke patients focuses on improving functional independence, reducing disability, and preventing secondary complications.


Locations(1)

China Medical University Hospital Taichung East District Branch

Taichung, Taiwan

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NCT06711003


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