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Recruiting NCT06711003

Effectiveness of Enhanced External Counterpulsation for Post-acute Stroke Patients

No phase Interventional Cerebrovascular Accident (CVA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: enhanced external counterpulsation, post acute care.
Who it may be relevant to
Registry conditions: Cerebrovascular Accident (CVA). Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Device enhanced 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 enhanc
  • Procedure post acute care
    Post-Acute Care (PAC) for stroke patients focuses on improving functional independence, reducing disability, and preventing secondary complications.

Primary outcome measures

  • Modified Rankin Scale (MRS) [Time frame: 0, 3, 6, 9 weeks]
  • Barthel Activity Daily Living Index [Time frame: 0, 3, 6, 9 weeks]
  • Lawton-Brody Instrumental Activity Daily Living scale [Time frame: 0, 3, 6, 9 weeks]
  • Functional Oral Intake Scale [Time frame: 0, 3, 6, 9 weeks]
  • Mini Nutrition Assessment [Time frame: 0, 3, 6, 9 weeks]
  • EuroQol Five Dimensions Questionnaire (EQ-5D) [Time frame: 0, 3, 6, 9 weeks]
  • Berg Balance Scale (BBS) [Time frame: 0, 3, 6, 9 weeks]
  • Gait speed [Time frame: 0, 3, 6, 9 weeks]
  • Mini Mental State Examination [Time frame: 0, 3, 6, 9 weeks]
  • Short Portable Mental Status Questionnaire (SPMSQ) [Time frame: 0, 3, 6, 9 weeks]
Secondary outcome measures (1)
  • ankle-brachial index [Time frame: 0 and 9 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • China Medical University Hospital Taichung East District Branch — Taichung

Identifiers

NCT: NCT06711003 · CMUH113-REC3-136

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗