Cerebrovascular Accident (CVA)NCT06711003
Effectiveness of Enhanced External Counterpulsation for Post-acute Stroke Patients
A study testing enhanced external counterpulsation and post acute care in people with Cerebrovascular Accident (CVA), run by China Medical University Hospital at 1 site in Taiwan.
Trial 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.. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cerebrovascular Accident (CVA)
- What is being tested?
- enhanced external counterpulsation and post acute care
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Oct 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital Taichung East District Branch
Taichung
Li-Wei Chou, 886+975681612, chouliwe@gmail.com
About this study
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.
- Conditions
- Cerebrovascular Accident (CVA)
- Being tested
- enhanced external counterpulsation, post acute care
- Keywords
- Cerebrovascular Accident (CVA), enhanced external counterpulsation, post-acute care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced external counterpulsationDevice
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.
post acute careProcedure or surgery
Post-Acute Care (PAC) for stroke patients focuses on improving functional independence, reducing disability, and preventing secondary complications.
| Study group | Role | What they receive |
|---|---|---|
| EECP+PAC | Experimental | Patients receive 35 times EECP treatments during standard PAC program. Receives: Device: enhanced external counterpulsation; Procedure: post acute care |
| PAC | Active comparator | Patients receive standard PAC program. Receives: Procedure: post acute care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (MRS)
A 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. It is used to categorize level of functional independence with reference to pre-stroke activities. Activity limitations are difficulties in performance of activities.It can be documented by the physician/APN/PA, nurse (RN), medical assistant, or any individual trained to perform the mRS.
Measured: 0, 3, 6, 9 weeks
Barthel Activity Daily Living Index
The Barthel Index-based Supplementary Scales assesses basic activities of daily living using three scales:actual performance, ability, and self-perceived difficulty. The score ranges the three scales (i.e., actual performance, ability, and self-perceived difficulty)is 0-20, 0-18, and 0-20, respectively. A higher score indicates better basic activities of daily living.
Measured: 0, 3, 6, 9 weeks
Lawton-Brody Instrumental Activity Daily Living scale
It consists of 8 questions including information about telephone use, meal preparation, shopping, doing daily household chores, laundry, getting on transportation, traveling, medication use and management of finances.
Measured: 0, 3, 6, 9 weeks
Functional Oral Intake Scale
The Functional Oral Intake Scale (FOIS) is a reliable and valid tool for assessing functional oral food and fluid intake in patients with oropharyngeal dysphagia (OD). Fois has seven levels, with higher levels indicating better swallowing function.
Measured: 0, 3, 6, 9 weeks
Mini Nutrition Assessment
questionnaire score (maximum score 30): total score > 23.5 = normal nutritional status; total score < 23.5 = inadequate nutritional status
Measured: 0, 3, 6, 9 weeks
EuroQol Five Dimensions Questionnaire (EQ-5D)
EuroQol Five Dimension 5-level (validated measure for health-related quality of life). This is a validated measure of health-related quality of life (HRQoL) (see references).
Subjects are asked to rate the level of problems they experience related to 5 domains of HRQoL (mobility, self care, usual activities, pain/discomfort and anxiety/depression). There are 5 values to choose from in each domain (e.g. no problem, slight problem, moderate problem, severe problem, unable to). A higher score indicates a worse quality of life.
EQ-5D scores are converted to overall utilities by averaging domains and weighting by the general public's valuation of the domains. A higher overall utility score for EQ-5D represents better HRQoL.
Measured: 0, 3, 6, 9 weeks
Berg Balance Scale (BBS)
A testing tool with high validity ( 0.93) and reliability (0.98) was used to measure balance in the elderly. The Berg Balance Scale (BBS) is a valid tool. The total score for the BBS is 56 and a higher score means good balance. It will be measured at baseline, 4th week and 8th week.
Measured: 0, 3, 6, 9 weeks
Gait speed
m/s
Measured: 0, 3, 6, 9 weeks
Mini Mental State Examination
The Mini Mental State Examination general cognitive function. The score ranges is 0 to 30. A higher score indicates better general cognitive function.
Measured: 0, 3, 6, 9 weeks
Short Portable Mental Status Questionnaire (SPMSQ)
Based on psychiatric examination using the Indonesian SPMSQ to determine patient's cognitive status. An SPMSQ test in which the patient demonstrated more than 3 mistakes implies mild cognitive impairment, whereas a mistake of greater than 8 implies dementia.
Measured: 0, 3, 6, 9 weeks
Fugl-Meyer Assessment
The Fugl-Meyer Assessment scale is an index to assess the sensorimotor impairment in individuals who have had stroke. The score ranges is 0 to 226. A higher score indicates better body function.
Measured: 0, 3, 6, 9 weeks
Motor Activity Log
The Motor Activity Log (MAL) is a semistructured interview for hemiparetic stroke patients to assess the use of their paretic arm and hand (amount of use [AOU]) and quality of movement [QOM]) during activities of daily living. Scores range from 0 to 5.
Measured: 0, 3, 6, 9 weeks
Albert's Test
Albert's Test is is screening tool used to detect the presence of unilateral spatial neglect (USN) in patients with stroke. Patients cross out lines ruled in a standard fashion on a sheet of paper.
Measured: 0, 3, 6, 9 weeks
Canadian Occupational Performance Measure
It is a semi-structured scale that helps to identify problematic areas of performance experienced by individuals and to measure their perceived occupational performance and satisfaction. This scale assesses the level of performance of self-care, productivity and leisure and satisfaction with these performances as perceived by the individual.
Measured: 0, 3, 6, 9 weeks
Secondary outcomes (1)
ankle-brachial index
The ankle-brachial index test compares the blood pressure in the ankle with the blood pressure in the arm.
Measured: 0 and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start22 Oct 2024
- Primary completion15 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular Accident (CVA)Studies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711003
- Sponsor's protocol ID
- CMUH113-REC3-136
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Enhanced External Counterpulsation for Post-acute Stroke Patients
- ClinicalTrials.gov ID
- NCT06711003
- Acronym / sponsor ID
- CMUH113-REC3-136
- Conditions
- Cerebrovascular Accident (CVA)
- Keywords
- Cerebrovascular Accident (CVA), enhanced external counterpulsation, post-acute care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EECP+PAC | Experimental | Device: enhanced external counterpulsation, Procedure: post acute carePatients receive 35 times EECP treatments during standard PAC program. |
| PAC | Active comparator | Procedure: post acute carePatients receive standard PAC program. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enhanced external counterpulsationEnhanced 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. | Device | EECP+PAC |
| post acute carePost-Acute Care (PAC) for stroke patients focuses on improving functional independence, reducing disability, and preventing secondary complications. | Procedure or surgery | EECP+PAC, PAC |
Primary outcome
Modified Rankin Scale (MRS)
Time frame: 0, 3, 6, 9 weeks
A 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire. It is used to categorize level of functional independence with reference to pre-stroke activities. Activity limitations are difficulties in performance of activities.It can be documented by the physician/APN/PA, nurse (RN), medical assistant, or any individual trained to perform the mRS.
Barthel Activity Daily Living Index
Time frame: 0, 3, 6, 9 weeks
The Barthel Index-based Supplementary Scales assesses basic activities of daily living using three scales:actual performance, ability, and self-perceived difficulty. The score ranges the three scales (i.e., actual performance, ability, and self-perceived difficulty)is 0-20, 0-18, and 0-20, respectively. A higher score indicates better basic activities of daily living.
Lawton-Brody Instrumental Activity Daily Living scale
Time frame: 0, 3, 6, 9 weeks
It consists of 8 questions including information about telephone use, meal preparation, shopping, doing daily household chores, laundry, getting on transportation, traveling, medication use and management of finances.
Functional Oral Intake Scale
Time frame: 0, 3, 6, 9 weeks
The Functional Oral Intake Scale (FOIS) is a reliable and valid tool for assessing functional oral food and fluid intake in patients with oropharyngeal dysphagia (OD). Fois has seven levels, with higher levels indicating better swallowing function.
Mini Nutrition Assessment
Time frame: 0, 3, 6, 9 weeks
questionnaire score (maximum score 30): total score > 23.5 = normal nutritional status; total score < 23.5 = inadequate nutritional status
EuroQol Five Dimensions Questionnaire (EQ-5D)
Time frame: 0, 3, 6, 9 weeks
EuroQol Five Dimension 5-level (validated measure for health-related quality of life). This is a validated measure of health-related quality of life (HRQoL) (see references). Subjects are asked to rate the level of problems they experience related to 5 domains of HRQoL (mobility, self care, usual activities, pain/discomfort and anxiety/depression). There are 5 values to choose from in each domain (e.g. no problem, slight problem, moderate problem, severe problem, unable to). A higher score indicates a worse quality of life. EQ-5D scores are converted to overall utilities by averaging domains and weighting by the general public's valuation of the domains. A higher overall utility score for EQ-5D represents better HRQoL.
Berg Balance Scale (BBS)
Time frame: 0, 3, 6, 9 weeks
A testing tool with high validity ( 0.93) and reliability (0.98) was used to measure balance in the elderly. The Berg Balance Scale (BBS) is a valid tool. The total score for the BBS is 56 and a higher score means good balance. It will be measured at baseline, 4th week and 8th week.
Gait speed
Time frame: 0, 3, 6, 9 weeks
m/s
Mini Mental State Examination
Time frame: 0, 3, 6, 9 weeks
The Mini Mental State Examination general cognitive function. The score ranges is 0 to 30. A higher score indicates better general cognitive function.
Short Portable Mental Status Questionnaire (SPMSQ)
Time frame: 0, 3, 6, 9 weeks
Based on psychiatric examination using the Indonesian SPMSQ to determine patient's cognitive status. An SPMSQ test in which the patient demonstrated more than 3 mistakes implies mild cognitive impairment, whereas a mistake of greater than 8 implies dementia.
Fugl-Meyer Assessment
Time frame: 0, 3, 6, 9 weeks
The Fugl-Meyer Assessment scale is an index to assess the sensorimotor impairment in individuals who have had stroke. The score ranges is 0 to 226. A higher score indicates better body function.
Motor Activity Log
Time frame: 0, 3, 6, 9 weeks
The Motor Activity Log (MAL) is a semistructured interview for hemiparetic stroke patients to assess the use of their paretic arm and hand (amount of use [AOU]) and quality of movement [QOM]) during activities of daily living. Scores range from 0 to 5.
Albert's Test
Time frame: 0, 3, 6, 9 weeks
Albert's Test is is screening tool used to detect the presence of unilateral spatial neglect (USN) in patients with stroke. Patients cross out lines ruled in a standard fashion on a sheet of paper.
Canadian Occupational Performance Measure
Time frame: 0, 3, 6, 9 weeks
It is a semi-structured scale that helps to identify problematic areas of performance experienced by individuals and to measure their perceived occupational performance and satisfaction. This scale assesses the level of performance of self-care, productivity and leisure and satisfaction with these performances as perceived by the individual.
1 secondary outcome
ankle-brachial index
Time frame: 0 and 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced external counterpulsation and post acute care in people with Cerebrovascular Accident (CVA), run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li-Wei Chou, PhD (886+975681612, chouliwe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (MRS) (time frame: 0, 3, 6, 9 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.