Using enhanced external counterpulsation to help stroke patients recover

Effectiveness of Enhanced External Counterpulsation for Post-acute Stroke Patients

This study is testing if adding a special treatment called enhanced external counterpulsation to regular rehab can help stroke patients recover better after their stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: China Medical University Hospital (Academic / other)
• Locations: 1 site (Taichung)
• Trial ID: NCT06711003 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of combining enhanced external counterpulsation (EECP) with standard post-acute care (PAC) rehabilitation for patients who have recently experienced a stroke. Researchers will assess the feasibility of this combination and its impact on improving functional outcomes compared to standard PAC alone. The study focuses on patients within one month of a cerebrovascular accident who have stable medical conditions and moderate to moderately severe functional impairments. The goal is to determine if EECP can enhance recovery in post-stroke patients.

Who should consider this trial

Good fit: Ideal candidates are adults over 20 years old who have experienced an acute cerebrovascular accident within the last month and have moderate to moderately severe functional impairments.

Not a fit: Patients with severe complications or those unable to participate actively in rehabilitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for stroke patients undergoing rehabilitation.

How similar studies have performed: While the combination of EECP with PAC is a novel approach, similar studies have shown promise in enhancing recovery in other patient populations.

Eligibility criteria

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.

Where this trial is running

Taichung

• China Medical University Hospital Taichung East District Branch — Taichung, Taiwan (Recruiting)

Study contacts

• Study coordinator: Li-Wei Chou, PhD

Conditions Cerebrovascular Accident; enhanced external counterpulsation; post-acute care