Effectiveness of Enhanced External Counterpulsation for Post-acute Stroke Patients

China Medical University

Status: Enrolling

Conditions: Cerebrovascular Accident (CVA)

Treatments: Procedure: post acute care; Device: enhanced external counterpulsation

Study type: Interventional

Funder types: Other

Identifiers

NCT06711003

CMUH113-REC3-136

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

110 participants in 2 patient groups

EECP+PAC

Experimental group

Description:

Patients receive 35 times EECP treatments during standard PAC program.

Treatment:

Device: enhanced external counterpulsation

Procedure: post acute care

PAC

Active Comparator group

Description:

Patients receive standard PAC program.

Treatment:

Procedure: post acute care