Clinical trial NCT06711003: Effectiveness of Enhanced External Counterpulsation for Post-acute Stroke Patients
Official title: Effectiveness of Enhanced External Counterpulsation for Post-acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebrovascular Accident (CVA)
Keywords: Cerebrovascular Accident (CVA)
enhanced external counterpulsation
post-acute care
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Modified Rankin Scale (MRS)
timeFrame: 0, 3, 6, 9 weeks
measure: Barthel Activity Daily Living Index
timeFrame: 0, 3, 6, 9 weeks
measure: Lawton-Brody Instrumental Activity Daily Living scale
timeFrame: 0, 3, 6, 9 weeks
measure: Functional Oral Intake Scale
timeFrame: 0, 3, 6, 9 weeks
measure: Mini Nutrition Assessment
timeFrame: 0, 3, 6, 9 weeks
measure: EuroQol Five Dimensions Questionnaire (EQ-5D)
timeFrame: 0, 3, 6, 9 weeks
measure: Berg Balance Scale (BBS)
timeFrame: 0, 3, 6, 9 weeks
measure: Gait speed
timeFrame: 0, 3, 6, 9 weeks
measure: Mini Mental State Examination
timeFrame: 0, 3, 6, 9 weeks
measure: Short Portable Mental Status Questionnaire (SPMSQ)
timeFrame: 0, 3, 6, 9 weeks
measure: Fugl-Meyer Assessment
timeFrame: 0, 3, 6, 9 weeks
measure: Motor Activity Log
timeFrame: 0, 3, 6, 9 weeks
measure: Albert's Test
timeFrame: 0, 3, 6, 9 weeks
measure: Canadian Occupational Performance Measure
timeFrame: 0, 3, 6, 9 weeks
Secondary outcomes:
measure: ankle-brachial index
timeFrame: 0 and 9 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital Taichung East District Branch
Study officials:
References: