Ischemic StrokeNCT06224517
Pulse Wave Velocity and in Subacute Stroke Patients Following Rehabilitation
An observational study of Ischemic Stroke and Arterial Stiffness, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
Currently, the literature regarding the relationship between Pulse Wave Velocity (PWV) and functional recovery, particularly of upper limb function, in patients with subacute stroke is still limited. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Stroke, Arterial Stiffness, Pulse Wave Velocity
- What is being tested?
- Rehabilitation
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2024to 30 Jun 2025
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Twenty-five patients admitted to the Department of Physical Medicine and Rehabilitation Medicine at Shin-Kong Wu Ho Su Memorial Hospital will be enrolled prospectively.
Who may be able to join
- First-onset cerebral ischemic stroke within the previous 3 months, which is confirmed clinically by computed tomography scans or magnetic resonance imaging
- Sufficient cognition to understand procedures and provide informed consent.
Who cannot join
- Hemorrhagic stroke, cerebellar or brainstem lesions which may affect autonomic or balance
- Concurrent neurological or neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis, etc.)
- Brain tumor
- Malignancy
- Limb deficiency or amputation
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
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111
Ying Chen Kuo, MD
About this study
Official title: The Improvement in Pulse Wave Velocity and Its Correlation With Clinical Outcomes in Subacute Stroke Patients Following Rehabilitation
Currently, the literature regarding the relationship between Pulse Wave Velocity (PWV) and functional recovery, particularly of upper limb function, in patients with subacute stroke is still limited. Therefore, the aim of the study is to evaluate the changes in baPWV after four weeks of intensive rehabilitation therapy, and the correlation between these changes and functional recovery.
Read the detailed description
Objectives: The purpose of this study is to evaluate the changes in baPWV after four weeks of intensive rehabilitation therapy, and the correlation between these changes and functional recovery.
Background: Arterial stiffness, increasing with age, is a significant risk factor for atherosclerotic diseases and a predictor of mortality from various causes, including symptomatic strokes. The brachial-ankle pulse wave velocity (baPWV), a reliable measure of arterial stiffness, correlates with cardiovascular events and mortality risk. Clinical improvements post-ischemic stroke align with a decrease in PWV, emphasizing arterial stiffness's role in recovery. Previous studies indicate significant differences in pressure waveforms and baPWV between stroke patients and control groups. Despite evidence of baPWV's prognostic value in predicting functional outcomes after acute cerebral infarction, the literature on its relation to functional recovery, especially upper limb function, in subacute stroke patients remains limited.
Study Design: Twenty-five patients admitted to the Department of Physical Medicine and Rehabilitation Medicine at Shin-Kong Wu Ho Su Memorial Hospital will be enrolled prospectively. Demographic and baseline clinical data, including age, gender, stroke duration (day), lesion side, stroke type, underlying disease, severity of neurological deficit (NIHSS) at admission were recorded. Once their neurological symptoms have stabilized, all patients will have their baPWV and functional outcome measurements before and four weeks after undergoing intensive rehabilitation therapy.
Methods: Inclusion criteria are as follows: first-onset cerebral ischemic stroke within the previous 3 months, which is confirmed clinically by computed tomography scans or magnetic resonance imaging; sufficient cognition to understand procedures and provide informed consent. Exclusion criteria are as follows: hemorrhagic stroke, cerebellar or brainstem lesions which may affect autonomic or balance; concurrent neurological or neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis, etc.), brain tumor, malignancy, limb deficiency or amputation.
The intervention includes daily physical and occupational therapy sessions tailored to each patient's functional status. In this study, stroke patients will undergo a four-week rehabilitation therapy program comprising 60-minute daily sessions of physical and occupational therapy. The physical therapy includes balance training, mobility and strengthening exercises, while occupational therapy covers sensorimotor and fine motor training, and ADL activities. The primary outcome is baPWV, measured noninvasively using an oscillometric method. Patients maintain their prescribed medication regime throughout. Secondary outcomes assessed include activities of daily living, balance, gait function, ambulation, and upper limb function.
Effect: Arterial stiffness in subacute stroke patients can be improved after four weeks of intensive rehabilitation therapy. After four weeks of intensive rehabilitation training, the brachial-ankle pulse wave velocity (baPWV) will decrease and will be negatively correlated with functional recovery.
- Being tested
- Rehabilitation
- Keywords
- ischemic stroke, Arterial Stiffness, pulse wave velocity, rehabilitation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
The intervention includes daily physical and occupational therapy sessions tailored to each patient's functional status. In this study, stroke patients will undergo a four-week rehabilitation therapy program comprising 60-minute daily sessions of physical and occupational therapy. The physical therapy includes balance training, mobility and strengthening exercises, while occupational therapy covers sensorimotor and fine motor training, and ADL activities.
| Study group | Role | What they receive |
|---|---|---|
| Patients of ischemic stroke | Inclusion criteria are as follows: first-onset cerebral ischemic stroke within the previous 3 months, which is confirmed clinically by computed tomography scans or magnetic resonance imaging; sufficient cognition to understand procedures and provide informed consent. Exclusion criteria are as follows: hemorrhagic stroke, cerebellar or brainstem lesions which may affect autonomic or balance; concurrent neurological or neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis, etc.), brain tumor, malignancy, limb deficiency or amputation. Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
brachial-ankle pulse wave velocity
baPWV is measured noninvasively using an oscillometric method (HBP-8000, Omron, Japan). The participants are required to abstain from caffeine for at least three hours prior to the test. The participant will be asked to rest in a supine position for a minimum of 10 minutes. Following this rest period, oscillometric cuffs were attached at the midway points of both arms and ankles for the simultaneous measurement of volume pulse and blood pressure. The arm-to-ankle distance was determined based on the patient's height. The baPWV was then computed by dividing the arm-ankle distance by the pulse time interval. The blood pressure analysis utilized the instantaneous systolic and diastolic blood pressure readings taken at the time of the baPWV measurement. For analytical purposes, an average of the values from both the left and right sides will be used.
Measured: 4-week
Secondary outcomes (4)
Activities of daily living
Chinese version of the Modified Barthel Index (MBI-C) is used to assess performance in basic ADL. The validity and reliability of MBI-C were good stroke patients according to previous research. the maximum score of 100 represents a patient fully independent in performing basic ADL, whereas the lowest score (0) represents a totally dependent state.
Measured: 4-week
Balance
he Berg balance scale (BBS) is used to assess balance function, providing a measure of a participant's stability while executing routine functional tasks encountered in daily life. The BBS uses a 5-point grading system, with each task scored from 0 to 4. A maximum achievable score of 56 represents an indication of excellent balance. The interrater reliability, intrarater reliability, and test-retest reliability were excellent in stroke patients.
Measured: 4-week
Gait function and ambulation
Gait function and ambulation ability are evaluated by Functional ambulation category (FAC). FAC test identifies six degrees of walking capability, determined by the extent of physical assistance needed. The FAC has six categories ranging from 0 (non-functional ambulation) to 5 (independent). It is straightforward to administer, simple to interpret, and cost-effective. The FAC has excellent reliability and good validity in stroke patients.
Measured: 4-week
Upper limb function
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is widely used in stroke patients to evaluate the severity of stroke and quantify the recovery process, and demonstrates good reliability, validity, and responsiveness. The assessment has 33 items, which are further divided into four subcategories: shoulder/elbow (comprising 18 items), wrist (5 items), hand (7 items), and coordination/speed (3 items). The scoring for each item is on a 3-point ordinal scale and a maximum total score of 66 indicates better sensorimotor function.
Measured: 4-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Feb 2024
- Primary completion15 Feb 2025
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Chen Kuo, Shin Kong Wu Ho-Su Memorial Hospital
- Investigators
- Ying-Chen Kuo, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224517
- Sponsor's protocol ID
- 20230706R
- Status last verified
- Feb 2025
- First submitted
- 5 Jan 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improvement in Pulse Wave Velocity and Its Correlation With Clinical Outcomes in Subacute Stroke Patients Following Rehabilitation
- ClinicalTrials.gov ID
- NCT06224517
- Acronym / sponsor ID
- 20230706R
- Keywords
- ischemic stroke, Arterial Stiffness, pulse wave velocity, rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 25 Jan 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.
Currently, the literature regarding the relationship between Pulse Wave Velocity (PWV) and functional recovery, particularly of upper limb function, in patients with subacute stroke is still limited. Therefore, the aim of the study is to evaluate the changes in baPWV after four weeks of intensive rehabilitation therapy, and the correlation between these changes and functional recovery.
Detailed description
Objectives: The purpose of this study is to evaluate the changes in baPWV after four weeks of intensive rehabilitation therapy, and the correlation between these changes and functional recovery.
Background: Arterial stiffness, increasing with age, is a significant risk factor for atherosclerotic diseases and a predictor of mortality from various causes, including symptomatic strokes. The brachial-ankle pulse wave velocity (baPWV), a reliable measure of arterial stiffness, correlates with cardiovascular events and mortality risk. Clinical improvements post-ischemic stroke align with a decrease in PWV, emphasizing arterial stiffness's role in recovery. Previous studies indicate significant differences in pressure waveforms and baPWV between stroke patients and control groups. Despite evidence of baPWV's prognostic value in predicting functional outcomes after acute cerebral infarction, the literature on its relation to functional recovery, especially upper limb function, in subacute stroke patients remains limited.
Study Design: Twenty-five patients admitted to the Department of Physical Medicine and Rehabilitation Medicine at Shin-Kong Wu Ho Su Memorial Hospital will be enrolled prospectively. Demographic and baseline clinical data, including age, gender, stroke duration (day), lesion side, stroke type, underlying disease, severity of neurological deficit (NIHSS) at admission were recorded. Once their neurological symptoms have stabilized, all patients will have their baPWV and functional outcome measurements before and four weeks after undergoing intensive rehabilitation therapy.
Methods: Inclusion criteria are as follows: first-onset cerebral ischemic stroke within the previous 3 months, which is confirmed clinically by computed tomography scans or magnetic resonance imaging; sufficient cognition to understand procedures and provide informed consent. Exclusion criteria are as follows: hemorrhagic stroke, cerebellar or brainstem lesions which may affect autonomic or balance; concurrent neurological or neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis, etc.), brain tumor, malignancy, limb deficiency or amputation.
The intervention includes daily physical and occupational therapy sessions tailored to each patient's functional status. In this study, stroke patients will undergo a four-week rehabilitation therapy program comprising 60-minute daily sessions of physical and occupational therapy. The physical therapy includes balance training, mobility and strengthening exercises, while occupational therapy covers sensorimotor and fine motor training, and ADL activities. The primary outcome is baPWV, measured noninvasively using an oscillometric method. Patients maintain their prescribed medication regime throughout. Secondary outcomes assessed include activities of daily living, balance, gait function, ambulation, and upper limb function.
Effect: Arterial stiffness in subacute stroke patients can be improved after four weeks of intensive rehabilitation therapy. After four weeks of intensive rehabilitation training, the brachial-ankle pulse wave velocity (baPWV) will decrease and will be negatively correlated with functional recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients of ischemic stroke | – | Other: RehabilitationInclusion criteria are as follows: first-onset cerebral ischemic stroke within the previous 3 months, which is confirmed clinically by computed tomography scans or magnetic resonance imaging; sufficient cognition to understand procedures and provide informed consent. Exclusion criteria are as follows: hemorrhagic stroke, cerebellar or brainstem lesions which may affect autonomic or balance; concurrent neurological or neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis, etc.), brain tumor, malignancy, limb deficiency or amputation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty-five patients admitted to the Department of Physical Medicine and Rehabilitation Medicine at Shin-Kong Wu Ho Su Memorial Hospital will be enrolled prospectively.
Key inclusion criteria (2 listed)
- First-onset cerebral ischemic stroke within the previous 3 months, which is confirmed clinically by computed tomography scans or magnetic resonance imaging
- Sufficient cognition to understand procedures and provide informed consent.
Key exclusion criteria (5 listed)
- Hemorrhagic stroke, cerebellar or brainstem lesions which may affect autonomic or balance
- Concurrent neurological or neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis, etc.)
- Brain tumor
- Malignancy
- Limb deficiency or amputation
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 |
|---|---|---|
| RehabilitationThe intervention includes daily physical and occupational therapy sessions tailored to each patient's functional status. In this study, stroke patients will undergo a four-week rehabilitation therapy program comprising 60-minute daily sessions of physical and occupational therapy. The physical therapy includes balance training, mobility and strengthening exercises, while occupational therapy covers sensorimotor and fine motor training, and ADL activities. | Other | Patients of ischemic stroke |
Primary outcome
brachial-ankle pulse wave velocity
Time frame: 4-week
baPWV is measured noninvasively using an oscillometric method (HBP-8000, Omron, Japan). The participants are required to abstain from caffeine for at least three hours prior to the test. The participant will be asked to rest in a supine position for a minimum of 10 minutes. Following this rest period, oscillometric cuffs were attached at the midway points of both arms and ankles for the simultaneous measurement of volume pulse and blood pressure. The arm-to-ankle distance was determined based on the patient's height. The baPWV was then computed by dividing the arm-ankle distance by the pulse time interval. The blood pressure analysis utilized the instantaneous systolic and diastolic blood pressure readings taken at the time of the baPWV measurement. For analytical purposes, an average of the values from both the left and right sides will be used.
4 secondary outcomes
Activities of daily living
Time frame: 4-week
Balance
Time frame: 4-week
Gait function and ambulation
Time frame: 4-week
Upper limb function
Time frame: 4-week
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 25 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Ying-Chen Kuo, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Arterial Stiffness, run by Shin Kong Wu Ho-Su Memorial 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 2 inclusion and 5 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 25 Feb 2025. 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 Ying-Chen Kuo, MD (+886-952848997, allazure1121@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brachial-ankle pulse wave velocity (time frame: 4-week). 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 25 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.